GLYBURIDE tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
GLYBURIDE (UNII: SX6K58TVWC) (GLYBURIDE - UNII:SX6K58TVWC)
Available from:
RPK Pharmaceuticals, Inc.
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Glyburide tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glyburide tablets are contraindicated in patients with:   - Known hypersensitivity or allergy to the drug. - Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin. - Type I diabetes mellitus. - Concomitant administration of bosentan. SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITY The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with non-insulin-dependent diabetes. The study involved 823 patients who were randomly assigned to one of fo
Product summary:
Product: 53002-4170 NDC: 53002-4170-3 30 TABLET in a BOTTLE NDC: 53002-4170-6 60 TABLET in a BOTTLE NDC: 53002-4170-0 100 TABLET in a BOTTLE
Authorization status:
Abbreviated New Drug Application
Authorization number:
53002-4170-0, 53002-4170-3, 53002-4170-6

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GLYBURIDE- glyburide tablet

RPK Pharmaceuticals, Inc.

----------

Glyburide Tablets, USP

Rx only

DESCRIPTION

Glyburide tablets, USP contain a smaller particle size glyburide, which is an oral blood-glucose-

lowering drug of the sulfonylurea class. Glyburide is a white, crystalline compound, formulated as

glyburide tablets, USP of 1.25, 2.5, and 5 mg strengths for oral administration. Inactive ingredients:

lactose monohydrate, microcrystalline cellulose, magnesium stearate. In addition, the 2.5 mg contains

FD&C Red No.40 and the 5 mg contains FD&C Blue No.1. The chemical name for glyburide is 1-[[p-

[2-(5-chloro-o-anisamido)-ethyl]phenyl]-sulfonyl]-3-cyclohexylurea and the molecular weight is

493.99. The structural formula is represented below.

CLINICAL PHARMACOLOGY

Actions

Glyburide appears to lower the blood glucose acutely by stimulating the release of insulin from the

pancreas, an effect dependent upon functioning beta cells in the pancreatic islets. The mechanism by

which glyburide lowers blood glucose during long-term administration has not been clearly

established. With chronic administration in Type II diabetic patients, the blood glucose lowering effect

persists despite a gradual decline in the insulin secretory response to the drug. Extrapancreatic effects

may be involved in the mechanism of action of oral sulfonylurea hypoglycemic drugs. The combination

of glyburide and metformin may have a synergistic effect, since both agents act to improve glucose

tolerance by different but complementary mechanisms.

Some patients, who are initially responsive to oral hypoglycemic drugs, including glyburide tablets,

may become unresponsive or poorly responsive over time. Alternatively, glyburide tablets may be

effective in some patients who have become unresponsive to one or more other sulfonylurea drugs.

In addition to its blood glucose lowering actions, glyburide produces a mild diuresis by enhancement of

renal free water clearance. Disulfiram-like reactions have very rarely been reported in patients treated

with glyburide tablets.

Pharmacokinetics

Single dose studies with glyburide tablets in normal subjects demonstrate significant absorption of

glyburide within one hour, peak drug levels at about four hours, and low but detectable levels at twenty-

four hours. Mean serum levels of glyburide, as reflected by areas under the serum concentration-time

curve, increase in proportion to corresponding increases in dose. Multiple dose studies with glyburide

tablets in diabetic patients demonstrate drug level concentration-time curves similar to single dose

studies, indicating no buildup of drug in tissue depots. The decrease of glyburide in the serum of

normal healthy individuals is biphasic; the terminal half-life is about 10 hours. In single dose studies in

fasting normal subjects, the degree and duration of blood glucose lowering is proportional to the dose

administered and to the area under the drug level concentration-time curve. The blood glucose lowering

administered and to the area under the drug level concentration-time curve. The blood glucose lowering

effect persists for 24 hours following single morning doses in nonfasting diabetic patients. Under

conditions of repeated administration in diabetic patients, however, there is no reliable correlation

between blood drug levels and fasting blood glucose levels. A one year study of diabetic patients

treated with glyburide tablets showed no reliable correlation between administered dose and serum

drug level.

The major metabolite of glyburide is the 4-transhydroxy derivative. A second metabolite, the 3-

cishydroxy derivative, also occurs. These metabolites probably contribute no significant hypoglycemic

action in humans since they are only weakly active (1/400th and 1/40th as active, respectively, as

glyburide) in rabbits.

Glyburide is excreted as metabolites in the bile and urine, approximately 50% by each route. This dual

excretory pathway is qualitatively different from that of other sulfonylureas, which are excreted

primarily in the urine.

Sulfonylurea drugs are extensively bound to serum proteins. Displacement from protein binding sites by

other drugs may lead to enhanced hypoglycemic action. In vitro, the protein binding exhibited by

glyburide is predominantly non-ionic, whereas that of other sulfonylureas (chlorpropamide,

tolbutamide, tolazamide) is predominantly ionic. Acidic drugs such as phenylbutazone, warfarin, and

salicylates displace the ionic-binding sulfonylureas from serum proteins to a far greater extent than the

non-ionic binding glyburide. It has not been shown that this difference in protein binding will result in

fewer drug-drug interactions with glyburide tablets in clinical use.

INDICATIONS AND USAGE

Glyburide tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in

adults with type 2 diabetes mellitus.

CONTRAINDICATIONS

Glyburide tablets are contraindicated in patients with:

1. Known hypersensitivity or allergy to the drug.

2. Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.

3. Type I diabetes mellitus.

4. Concomitant administration of bosentan.

SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITY

The administration of oral hypoglycemic drugs has been reported to be associated with

increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin.

This warning is based on the study conducted by the University Group Diabetes Program

(UGDP), a long-term prospective clinical trial designed to evaluate the effectiveness of glucose-

lowering drugs in preventing or delaying vascular complications in patients with non-insulin-

dependent diabetes. The study involved 823 patients who were randomly assigned to one of four

treatment groups.

UGDP reported that patients treated for 5 to 8 years with diet plus a fixed dose of tolbutamide (1.5

grams per day) had a rate of cardiovascular mortality approximately 2½ times that of patients

treated with diet alone. A significant increase in total mortality was not observed, but the use of

tolbutamide was discontinued based on the increase in cardiovascular mortality, thus limiting the

opportunity for the study to show an increase in overall mortality. Despite controversy regarding

the interpretation of these results, the findings of the UGDP study provide an adequate basis for

this warning. The patient should be informed of the potential risks and advantages of glyburide

tablets and of alternative modes of therapy.

Although only one drug in the sulfonylurea class (tolbutamide) was included in this study, it is

prudent from a safety standpoint to consider that this warning may also apply to other oral

hypoglycemic drugs in this class, in view of their close similarities in mode of action and chemical

s tructure.

PRECAUTIONS

General

Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of

macrovascular risk reduction with glyburide tablets or any other anti-diabetic drug.

Hypoglycemia: All sulfonylureas including glyburide are capable of producing severe hypoglycemia.

Proper patient selection and dosage and instructions are important to avoid hypoglycemic episodes.

Renal or hepatic insufficiency may cause elevated drug levels of glyburide and the latter may also

diminish gluconeogenic capacity, both of which increase the risk of serious hypoglycemic reactions.

Elderly, debilitated or malnourished patients, and those with adrenal or pituitary insufficiency, are

particularly susceptible to the hypoglycemic action of glucose-lowering drugs. Hypoglycemia may be

difficult to recognize in the elderly and in people who are taking beta-adrenergic blocking drugs.

Hypoglycemia is more likely to occur when caloric intake is deficient, after severe or prolonged

exercise, when alcohol is ingested, or when more than one glucose lowering drug is used. The risk of

hypoglycemia may be increased with combination therapy.

Loss of Control of Blood Glucose: When a patient stabilized on any diabetic regimen is exposed to

stress such as fever, trauma, infection or surgery, a loss of control may occur. At such times it may be

necessary to discontinue glyburide tablets and administer insulin.

The effectiveness of any hypoglycemic drug, including glyburide tablets, in lowering blood glucose to

a desired level decreases in many patients over a period of time which may be due to progression of the

severity of diabetes or to diminished responsiveness to the drug. This phenomenon is known as

secondary failure, to distinguish it from primary failure in which the drug is ineffective in an individual

patient when glyburide tablets is first given. Adequate adjustment of dose and adherence to diet should

be assessed before classifying a patient as a secondary failure.

Hemolytic Anemia:

Treatment of patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency with sulfonylurea

agents can lead to hemolytic anemia. Because glyburide tablets belongs to the class of sulfonylurea

agents, caution should be used in patients with G6PD deficiency and a non-sulfonylurea alternative

should be considered. In post marketing reports, hemolytic anemia has also been reported in patients

who did not have known G6PD deficiency.

Information for Patients:

Patients should be informed of the potential risks and advantages of glyburide tablets and of alternative

modes of therapy. They also should be informed about the importance of adherence to dietary

instructions, of a regular exercise program, and of regular testing of urine and/or blood glucose.

The risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its

development should be explained to patients and responsible family members. Primary and secondary

failure also should be explained.

Physician Counseling Information for Patients:

In initiating treatment for type 2 diabetes, diet should be emphasized as the primary form of treatment.

Caloric restriction and weight loss are essential in the obese diabetic patient. Proper dietary

management alone may be effective in controlling the blood glucose and symptoms of hyperglycemia.

The importance of regular physical activity should also be stressed, and cardiovascular risk factors

should be identified and corrective measures taken where possible. Use of glyburide tablets or other

antidiabetic medications must be viewed by both the physician and patient as a treatment in addition to

diet and not as a substitution or as a convenient mechanism for avoiding dietary restraint. Furthermore,

loss of blood glucose control on diet alone may be transient, thus requiring only short-term

administration of glyburide tablets or other antidiabetic medications. Maintenance or discontinuation of

glyburide tablets or other antidiabetic medications should be based on clinical judgment using regular

clinical and laboratory evaluations.

Laboratory Tests

Therapeutic response to glyburide tablets should be monitored by frequent urine glucose tests and

periodic blood glucose tests. Measurement of glycosylated hemoglobin levels may be helpful in some

patients.

Drug Interactions

The hypoglycemic action of sulfonylureas may be potentiated by certain drugs including nonsteroidal

anti-inflammatory agents and other drugs that are highly protein bound, salicylates, sulfonamides,

chloramphenicol, probenecid, coumarins, monoamine oxidase inhibitors, and beta adrenergic blocking

agents. When such drugs are administered to a patient receiving glyburide tablets, the patient should be

observed closely for hypoglycemia. When such drugs are withdrawn from a patient receiving glyburide

tablets, the patient should be observed closely for loss of control.

An increased risk of liver enzyme elevations was observed in patients receiving glyburide

concomitantly with bosentan. Therefore concomitant administration of glyburide tablets and bosentan is

contraindicated.

Certain drugs tend to produce hyperglycemia and may lead to loss of control. These drugs include the

thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral

contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and

isoniazid. When such drugs are administered to a patient receiving glyburide tablets, the patient should

be closely observed for loss of control. When such drugs are withdrawn from a patient receiving

glyburide tablets, the patient should be observed closely for hypoglycemia.

A possible interaction between glyburide and ciprofloxacin, a fluoroquinolone antibiotic, has been

reported, resulting in a potentiation of the hypoglycemic action of glyburide. The mechanism for this

interaction is not known.

A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe

hypoglycemia has been reported. Whether this interaction also occurs with the intravenous, topical or

vaginal preparations of miconazole is not known.

Metformin: In a single-dose interaction study in NIDDM subjects, decreases in glyburide AUC and

Cmax were observed, but were highly variable. The single-dose nature of this study and the lack of

correlation between glyburide blood levels and pharmacodynamic effects, makes the clinical

significance of this interaction uncertain. Coadministration of glyburide and metformin did not result in

any changes in either metformin pharmacokinetics or pharmacodynamics.

Colesevelam: Concomitant administration of colesevelam and glyburide resulted in reductions in

glyburide AUC and Cmax of 32% and 47%, respectively. The reductions in glyburide AUC and Cmax

were 20% and 15%, respectively when administered 1 hour before, and not significantly changed (-7%

and 4%, respectively) when administered 4 hours before colesevelam.

Topiramate: A drug-drug interaction study conducted in patients with type 2 diabetes evaluated the

steady-state pharmacokinetics of glyburide (5 mg/day) alone and concomitantly with topiramate (150

mg/day). There was a 22% decrease in Cmax and a 25% reduction in AUC24 for glyburide during

topiramate administration. Systemic exposure (AUC) of the active metabolites, 4-trans-hydroxy-

glyburide (M1) and 3-cis hydroxyglyburide (M2), was also reduced by 13% and 15%, and Cmax was

reduced by 18% and 25%, respectively. The steady-state pharmacokinetics of topiramate were

unaffected by concomitant administration of glyburide.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Studies in rats at doses up to 300 mg/kg/day for 18 months showed no carcinogenic effects. Glyburide

is nonmutagenic when studied in the Salmonella microsome test (Ames test) and in the DNA

damage/alkaline elution assay. No drug related effects were noted in any of the criteria evaluated in the

two year oncogenicity study of glyburide in mice.

Pregnancy

Teratogenic Effects: Pregnancy Category B

Reproduction studies have been performed in rats and rabbits at doses up to 500 times the human dose

and have revealed no evidence of impaired fertility or harm to the fetus due to glyburide. There are,

however, no adequate and well controlled studies in pregnant women. Because animal reproduction

studies are not always predictive of human response, this drug should be used during pregnancy only if

clearly needed.

Because recent information suggests that abnormal blood glucose levels during pregnancy are

associated with a higher incidence of congenital abnormalities, many experts recommend that insulin be

used during pregnancy to maintain blood glucose as close to normal as possible.

Nonteratogenic Effects: Prolonged severe hypoglycemia (4 to 10 days) has been reported in neonates

born to mothers who were receiving a sulfonylurea drug at the time of delivery. This has been reported

more frequently with the use of agents with prolonged half-lives. If glyburide tablets is used during

pregnancy, it should be discontinued at least two weeks before the expected delivery date.

Nursing Mothers

Although it is not known whether glyburide is excreted in human milk, some sulfonylurea drugs are

known to be excreted in human milk. Because the potential for hypoglycemia in nursing infants may

exist, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into

account the importance of the drug to the mother. If the drug is discontinued, and if diet alone is

inadequate for controlling blood glucose, insulin therapy should be considered.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Elderly patients are particularly susceptible to the hypoglycemic action of glucose lowering drugs.

Hypoglycemia may be difficult to recognize in the elderly (see PRECAUTIONS). The initial and

maintenance dosing should be conservative to avoid hypoglycemic reactions (see DOSAGE AND

ADMINISTRATION).

Elderly patients are prone to develop renal insufficiency, which may put them at risk of hypoglycemia.

Dose selection should include assessment of renal function.

ADVERSE REACTIONS

Hypoglycemia: See Precautions and Overdosage Sections.

Gastrointestinal Reactions: Cholestatic jaundice and hepatitis may occur rarely which may progress to

liver failure; glyburide tablets should be discontinued if this occurs.

Liver function abnormalities, including isolated transaminase elevations, have been reported.

Gastrointestinal disturbances, eg, nausea, epigastric fullness, and heartburn are the most common

reactions, having occurred in 1.8% of treated patients during clinical trials. They tend to be dose related

and may disappear when dosage is reduced.

Dermatologic Reactions: Allergic skin reactions, eg, pruritus, erythema, urticaria, and morbilliform or

maculopapular eruptions occurred in 1.5% of treated patients during clinical trials. These may be

transient and may disappear despite continued use of glyburide tablets; if skin reactions persist, the drug

should be discontinued.

Porphyria cutanea tarda and photosensitivity reactions have been reported with sulfonylureas.

Hematologic Reactions: Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia (see

PRECAUTIONS), aplastic anemia, and pancytopenia have been reported with sulfonylureas.

Metabolic Reactions: Hepatic porphyria and disulfiram-like reactions have been reported with

sulfonylureas; however, hepatic porphyria has not been reported with Glyburide tablets and disulfiram-

like reactions have been reported very rarely.

Cases of hyponatremia have been reported with glyburide and all other sulfonylureas, most often in

patients who are on other medications or have medical conditions known to cause hyponatremia or

increase release of antidiuretic hormone. The syndrome of inappropriate antidiuretic hormone (SIADH)

secretion has been reported with certain other sulfonylureas, and it has been suggested that these

sulfonylureas may augment the peripheral (antidiuretic) action of ADH and/or increase release of ADH.

Other Reactions: Changes in accommodation and/or blurred vision have been reported with glyburide

and other sulfonylureas. These are thought to be related to fluctuation in glucose levels.

In addition to dermatologic reactions, allergic reactions such as angioedema, arthralgia, myalgia and

vasculitis have been reported.

OVERDOSAGE

Overdosage of sulfonylureas, including glyburide tablets, can produce hypoglycemia. Mild

hypoglycemic symptoms, without loss of consciousness or neurological findings, should be treated

aggressively with oral glucose and adjustments in drug dosage and/or meal patterns. Close monitoring

should continue until the physician is assured that the patient is out of danger. Severe hypoglycemic

reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute

medical emergencies requiring immediate hospitalization. If hypoglycemic coma is diagnosed or

suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose

solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a

rate which will maintain the blood glucose at a level above 100 mg/dL. Patients should be closely

monitored for a minimum of 24 to 48 hours, since hypoglycemia may recur after apparent clinical

recovery.

DOSAGE AND ADMINISTRATION

Patients should be retitrated when transferred from glyburide tablets or other oral hypoglycemic

agents .

There is no fixed dosage regimen for the management of diabetes mellitus with glyburide tablets. In

addition to the usual monitoring of urinary glucose, the patient's blood glucose must also be monitored

periodically to determine the minimum effective dose for the patient; to detect primary failure, ie,

inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect

secondary failure, ie, loss of adequate blood glucose lowering response after an initial period of

effectiveness. Glycosylated hemoglobin levels may also be of value in monitoring the patient's

response to therapy.

Short-term administration of glyburide tablets may be sufficient during periods of transient loss of

control in patients usually controlled well on diet.

Usual Starting Dose

The usual starting dose of glyburide tablets is 2.5 to 5 mg daily, administered with breakfast or the first

main meal. Those patients who may be more sensitive to hypoglycemic drugs should be started at 1.25

mg daily. (See PRECAUTIONS section for patients at increased risk.) Failure to follow an appropriate

dosage regimen may precipitate hypoglycemia. Patients who do not adhere to their prescribed dietary

and drug regimen are more prone to exhibit unsatisfactory response to therapy.

Transfer From Other Hypoglycemic Therapy Patients Receiving Other Oral Antidiabetic

Therapy: Transfer of patients from other oral antidiabetic regimens to glyburide tablets should be done

conservatively and the initial daily dose should be 2.5 to 5 mg. When transferring patients from oral

hypoglycemic agents other than chlorpropamide to glyburide tablets, no transition period and no initial

or priming dose are necessary. When transferring patients from chlorpropamide, particular care should

be exercised during the first two weeks because the prolonged retention of chlorpropamide in the body

and subsequent overlapping drug effects may provoke hypoglycemia.

Patients Receiving Insulin: Some Type II diabetic patients being treated with insulin may respond

satisfactorily to glyburide tablets. If the insulin dose is less than 20 units daily, substitution of glyburide

tablets 2.5 to 5 mg as a single daily dose may be tried. If the insulin dose is between 20 and 40 units

daily, the patient may be placed directly on glyburide tablets 5 mg daily as a single dose. If the insulin

dose is more than 40 units daily, a transition period is required for conversion to glyburide tablets. In

these patients, insulin dosage is decreased by 50% and glyburide tablets 5 mg daily is started. Please

refer to Titration to Maintenance Dose for further explanation.

Patients Receiving Colesevelam: When colesevelam is coadministered with glyburide, maximum

plasma concentration and total exposure to glyburide is reduced. Therefore, glyburide tablets should be

administered at least 4 hours prior to colesevelam.

Titration to Maintenance Dose

The usual maintenance dose is in the range of 1.25 to 20 mg daily, which may be given as a single dose

or in divided doses (See Dosage Interval section). Dosage increases should be made in increments of

no more than 2.5 mg at weekly intervals based upon the patient's blood glucose response.

No exact dosage relationship exists between glyburide tablets and the other oral hypoglycemic agents.

Although patients may be transferred from the maximum dose of other sulfonylureas, the maximum

starting dose of 5 mg of glyburide tablets should be observed. A maintenance dose of 5 mg of

glyburide tablets provides approximately the same degree of blood glucose control as 250 to 375 mg

chlorpropamide, 250 to 375 mg tolazamide, 500 to 750 mg acetohexamide, or 1000 to 1500 mg

tolbutamide.

When transferring patients receiving more than 40 units of insulin daily, they may be started on a daily

dose of glyburide tablets 5 mg concomitantly with a 50% reduction in insulin dose. Progressive

withdrawal of insulin and increase of glyburide tablets in increments of 1.25 to 2.5 mg every 2 to 10

days is then carried out. During this conversion period when both insulin and glyburide tablets are being

used, hypoglycemia may occur. During insulin withdrawal, patients should test their urine for glucose

and acetone at least three times daily and report results to their physician. The appearance of persistent

acetonuria with glycosuria indicates that the patient is a Type I diabetic who requires insulin therapy.

Concomitant Glyburide and Metformin Therapy

Glyburide tablets should be added gradually to the dosing regimen of patients who have not responded

to the maximum dose of metformin monotherapy after four weeks (see Usual Starting Dose and Titration

to Maintenance Dose). Refer to metformin package insert.

With concomitant glyburide and metformin therapy, the desired control of blood glucose may be

obtained by adjusting the dose of each drug. However, attempts should be made to identify the optimal

dose of each drug needed to achieve this goal. With concomitant glyburide and metformin therapy, the

risk of hypoglycemia associated with sulfonylurea therapy continues and may be increased. Appropriate

precautions should be taken (see PRECAUTIONS section).

Maximum Dose

Daily doses of more than 20 mg are not recommended.

Dosage Interval

Once-a-day therapy is usually satisfactory. Some patients, particularly those receiving more than 10 mg

daily, may have a more satisfactory response with twice-a-day dosage.

Specific Patient Populations

Glyburide tablets is not recommended for use in pregnancy or for use in pediatric patients.

In elderly patients, debilitated or malnourished patients, and patients with impaired renal or hepatic

function, the initial and maintenance dosing should be conservative to avoid hypoglycemic reactions.

(See PRECAUTIONS section.)

HOW SUPPLIED

Product: 53002-4170

NDC: 53002-4170-3 30 TABLET in a BOTTLE

NDC: 53002-4170-6 60 TABLET in a BOTTLE

NDC: 53002-4170-0 100 TABLET in a BOTTLE

Glyburide 5mg Tablets

GLYBURIDE

glyburide tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:530 0 2-4170 (NDC:23155-0 58 )

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

GLYBURIDE (UNII: SX6 K58 TVWC) (GLYBURIDE - UNII:SX6 K58 TVWC)

GLYBURIDE

5 mg

Inactive Ingredients

RPK Pharmaceuticals, Inc.

Ingredient Name

Stre ng th

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

Product Characteristics

Color

BLUE

S core

2 pieces

S hap e

CAPSULE

S iz e

9 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:530 0 2-4170 -3

30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/0 1/20 20

2

NDC:530 0 2-4170 -6

6 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/0 1/20 20

3

NDC:530 0 2-4170 -0

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/0 1/20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 9 0 9 37

10 /0 5/20 10

Labeler -

RPK Pharmaceuticals, Inc. (147096275)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

RPK Pharmaceuticals, Inc.

1470 9 6 275

RELABEL(530 0 2-4170 ) , REPACK(530 0 2-4170 )

Revised: 12/2020

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