OXYBUTYNIN CHLORIDE- oxybutynin chloride tablet

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

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Active ingredient:
OXYBUTYNIN CHLORIDE (UNII: L9F3D9RENQ) (OXYBUTYNIN - UNII:K9P6MC7092)
Available from:
NuCare Pharmaceuticals, Inc.
INN (International Name):
OXYBUTYNIN CHLORIDE
Composition:
OXYBUTYNIN CHLORIDE 5 mg
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Oxybutynin Chloride Tablets USP are indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria). Oxybutynin chloride is contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. Oxybutynin chloride is also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product.
Product summary:
Oxybutynin Chloride Tablets USP are available as follows: 5 mg – Very pale blue, round, biconvex, scored tablets. Debossed with PLIVA 456 on one side and scored on the other side . Available in bottles of 20 NDC 68071-1875-2 bottles of 30 NDC 68071-1875-3 bottles of 60 NDC 68071-1875-6 bottles of 90 NDC 68071-1875-9 bottles of 120 NDC 68071-1875-1 bottles of 270 NDC 68071-1875-7 Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Authorization status:
Abbreviated New Drug Application
Authorization number:
68071-1875-1, 68071-1875-2, 68071-1875-3, 68071-1875-6, 68071-1875-7, 68071-1875-9

OXYBUTYNIN CHLORIDE- oxybutynin chloride tablet

NuCare Pharmaceuticals, Inc.

----------

OXYBUTYNIN CHLORIDE TABLETS USP

Rx Only

DESCRIPTION

Oxybutynin Chloride Tablets USP are very pale blue, round, biconvex, scored, debossed tablets

containing 5 mg of oxybutynin chloride, USP. Chemically, oxybutynin chloride, USP is d,l (racemic) 4-

diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The structural formula appears

below:

HCl M.W. 393.9

Oxybutynin chloride, USP is a white crystalline solid. It is readily soluble in water and acids, but

relatively insoluble in alkalis.

Oxybutynin Chloride Tablets USP also contain calcium stearate, microcrystalline cellulose, anhydrous

lactose, sodium starch glycolate and FD&C Blue #1 Aluminum Lake.

Oxybutynin Chloride Tablets USP are for oral administration.

Meets USP Dissolution Test 2.

Therapeutic Category: Antispasmodic, anticholinergic.

CLINICAL PHARMACOLOGY

Oxybutynin chloride exerts a direct antispasmodic effect on smooth muscle and inhibits the muscarinic

action of acetylcholine on smooth muscle. Oxybutynin chloride exhibits only one fifth of the

anticholinergic activity of atropine on the rabbit detrusor muscle, but four to ten times the antispasmodic

activity. No blocking effects occur at skeletal neuromuscular junctions or autonomic ganglia

(antinicotinic effects).

Oxybutynin chloride relaxes bladder smooth muscle. In patients with conditions characterized by

involuntary bladder contractions, cystometric studies have demonstrated that oxybutynin chloride

increases bladder (vesical) capacity, diminishes the frequency of uninhibited contractions of the

detrusor muscle, and delays the initial desire to void. Oxybutynin chloride thus decreases urgency and

the frequency of both incontinent episodes and voluntary urination.

Antimuscarinic activity resides predominately in the R-isomer. A metabolite, desethyloxybutynin, has

pharmacological activity similar to that of oxybutynin in in vitro studies.

Pharmacokinetics

Absorption

Following oral administration of oxybutynin chloride tablets, oxybutynin is rapidly absorbed achieving

within an hour, following which plasma concentration decreases with an effective half-life of

approximately 2 to 3 hours. The absolute bioavailability of oxybutynin is reported to be about 6%

(range 1.6 to 10.9%) for the tablets. Wide interindividual variation in pharmacokinetic parameters is

evident following oral administration of oxybutynin.

The mean pharmacokinetic parameters for R- and S-oxybutynin are summarized in Table 1. The plasma

concentration-time profiles for R- and S-oxybutynin are similar in shape; Figure 1 shows the profile for

R-oxybutynin.

Table 1: Mean (SD) R- and S-Oxybutynin Pharmacokinetic Parameters Following Three Doses of

Oxybutynin Chloride 5 mg Administered Every 8 Hours (n = 23)

Parameters (Units)

R-Oxybutynin

S-Oxybutynin

(ng/mL)

3.6 (2.2)

7.8 (4.1)

0.89 (0.34)

0.65 (0.32)

AUC (ng h/mL)

22.6 (11.3)

35 (17.3)

(ng h/mL)

24.3 (12.3)

37.3 (18.7)

Figure 1. Mean R-Oxybutynin Plasma Concentrations Following Three Doses of Oxybutynin Chloride 5

mg Administered Every 8 Hours for 1 Day in 23 Healthy Adult Volunteers

Oxybutynin chloride steady-state pharmacokinetics were also studied in 11 pediatric patients with

detrusor overactivity associated with a neurological condition (e.g., spina bifida). These pediatric

patients were on oxybutynin chloride tablets with total daily dose ranging from 7.5 mg to 15 mg (0.22 to

0.53 mg/kg). Overall, most patients (86.9%) were taking a total daily oxybutynin chloride dose between

10 mg and 15 mg. Sparse sampling technique was used to obtain serum samples. When all available data

are normalized to an equivalent of 5 mg twice daily oxybutynin chloride, the mean pharmacokinetic

parameters derived for R- and S-oxybutynin and R- and S-desethyloxybutynin are summarized in Table

2. The plasma-time concentration profiles for R- and S-oxybutynin are similar in shape; Figure 2 shows

the profile for R-oxybutynin when all available data are normalized to an equivalent of 5 mg twice daily.

Table 2: Mean ± SD R- and S-Oxybutynin and R- and S-Desethyloxybutynin Pharmacokinetic

Parameters in Children Aged 5 to 15 Following Administration of 7.5 mg to 15 mg Total Daily

Dose of Oxybutynin Chloride Tablets (N = 11)

All Available Data Normalized to an Equivalent of Oxybutynin Chloride Tablets 5 mg BID or TID at

Steady-State

R-Oxybutynin

S-Oxybutynin

R-Desethyloxybutynin

S-Desethyloxybutynin

(ng/mL)

6.1 ± 3.2

10.1 ± 7.5

55.4 ± 17.9

28.2 ± 10

(hr)

(ng.hr/mL) 19.8 ± 7.4

28.4 ± 12.7

238.8 ± 77.6

119.5 ± 50.7

Figure 2. Mean Steady-State (± SD) R-Oxybutynin Plasma Concentrations Following Administration of

Total Daily Oxybutynin Chloride Tablet Dose of 7.5 mg to 15 mg (0.22 mg/kg to 0.53 mg/kg) in

Children 5 to 15 Years of Age. – Plot Represents All Available Data Normalized to the Equivalent of

Oxybutynin Chloride 5 mg BID or TID at Steady-State

Food Effects

Data in the literature suggests that oxybutynin solution coadministered with food resulted in a slight

delay in absorption and an increase in its bioavailability by 25% (n = 18).

Distribution

Oxybutynin is widely distributed in body tissues following systemic absorption. The volume of

distribution is 193 L after intravenous administration of 5 mg oxybutynin chloride. Both enantiomers of

oxybutynin are highly bound (> 99%) to plasma proteins. Both enantiomers of desethyloxybutynin are

Reflects C max for pooled data

AUC 0-end of dosing interval

also highly bound (> 97%) to plasma proteins. The major binding protein is alpha-1 acid glycoprotein.

Metabolism

Oxybutynin is metabolized primarily by the cytochrome P450 enzyme systems, particularly CYP3A4

found mostly in the liver and gut wall. Its metabolic products include phenylcyclohexylglycolic acid,

which is pharmacologically inactive, and desethyloxybutynin, which is pharmacologically active.

Excretion

Oxybutynin is extensively metabolized by the liver, with less than 0.1% of the administered dose

excreted unchanged in the urine. Also, less than 0.1% of the administered dose is excreted as the

metabolite desethyloxybutynin.

CLINICAL STUDIES

Oxybutynin chloride was well tolerated in patients administered the drug in controlled studies of 30

days’ duration and in uncontrolled studies in which some of the patients received the drug for 2 years.

INDICATIONS AND USAGE

Oxybutynin Chloride Tablets USP are indicated for the relief of symptoms of bladder instability

associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e.,

urgency, frequency, urinary leakage, urge incontinence, dysuria).

CONTRAINDICATIONS

Oxybutynin chloride is contraindicated in patients with urinary retention, gastric retention and other

severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma and in

patients who are at risk for these conditions.

Oxybutynin chloride is also contraindicated in patients who have demonstrated hypersensitivity to the

drug substance or other components of the product.

WARNINGS

Angioedema of the face, lips, tongue and/or larynx has been reported with oxybutynin. In some cases,

angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be

life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, oxybutynin should be

promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway

should be promptly provided.

PRECAUTIONS

Central Nervous System Effects

Oxybutynin is associated with anticholinergic central nervous system (CNS) effects (see ADVERSE

REACTIONS). A variety of CNS anticholinergic effects have been reported, including hallucinations,

agitation, confusion and somnolence. Patients should be monitored for signs of anticholinergic CNS

effects, particularly in the first few months after beginning treatment or increasing the dose. If a patient

experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.

Oxybutynin chloride should be used with caution in patients with preexisting dementia treated with

cholinesterase inhibitors due to the risk of aggravation of symptoms.

General

Oxybutynin chloride should be used with caution in the frail elderly, in patients with hepatic or renal

impairment, and in patients with myasthenia gravis.

Oxybutynin chloride may aggravate the symptoms of hyperthyroidism, coronary heart disease,

congestive heart failure, cardiac arrhythmias, hiatal hernia, tachycardia, hypertension, myasthenia

gravis, and prostatic hypertrophy.

Urinary Retention

Oxybutynin chloride should be administered with caution to patients with clinically significant bladder

outflow obstruction because of the risk of urinary retention (see CONTRAINDICATIONS).

Gastrointestinal Disorders

Oxybutynin chloride should be administered with caution to patients with gastrointestinal obstructive

disorders because of the risk of gastric retention (see CONTRAINDICATIONS).

Administration of oxybutynin chloride to patients with ulcerative colitis may suppress intestinal motility

to the point of producing a paralytic ileus and precipitate or aggravate toxic megacolon, a serious

complication of the disease.

Oxybutynin chloride, like other anticholinergic drugs, may decrease gastrointestinal motility and should

be used with caution in patients with conditions such as ulcerative colitis, and intestinal atony.

Oxybutynin chloride should be used with caution in patients who have gastroesophageal reflux and/or

who are concurrently taking drugs (such as bisphosphonates) that can cause or exacerbate esophagitis.

Information for Patients

Patients should be informed that oxybutynin may produce angioedema that could result in life-

threatening airway obstruction. Patients should be advised to promptly discontinue oxybutynin therapy

and seek immediate medical attention if they experience edema of the tongue, edema of the

laryngopharynx, or difficulty breathing.

Patients should be informed that heat prostration (fever and heat stroke due to decreased sweating) can

occur when anticholinergics such as oxybutynin chloride are administered in the presence of high

environmental temperature.

Because anticholinergic agents such as oxybutynin may produce drowsiness (somnolence), or blurred

vision, patients should be advised to exercise caution.

Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents

such as oxybutynin.

Drug Interactions

The concomitant use of oxybutynin with other anticholinergic drugs or with other agents which

produce dry mouth, constipation, somnolence (drowsiness), and/or other anticholinergic-like effects

may increase the frequency and/or severity of such effects.

Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs

due to anticholinergic effects on gastrointestinal motility. This may be of concern for drugs with a

narrow therapeutic index.

Mean oxybutynin chloride plasma concentrations were approximately 3 to 4 fold higher when

oxybutynin chloride was administered with ketoconazole, a potent CYP3A4 inhibitor.

Other inhibitors of the cytochrome P450 3A4 enzyme system, such as antimycotic agents (e.g.,

itraconazole and miconazole) or macrolide antibiotics (e.g., erythromycin and clarithromycin), may alter

oxybutynin mean pharmacokinetic parameters (i.e., C

and AUC). The clinical relevance of such

potential interactions is not known. Caution should be used when such drugs are coadministered.

Carcinogenesis, Mutagenesis, Impairment of Fertility

A 24 month study in rats at dosages of oxybutynin chloride of 20, 80, and 160 mg/kg/day showed no

evidence of carcinogenicity. These doses are approximately 6, 25, and 50 times the maximum human

exposure, based on surface area.

Oxybutynin chloride showed no increase of mutagenic activity when tested in Schizosaccharomyces

pompholiciformis, Saccharomyces cerevisiae and Salmonella typhimurium test systems.

Reproduction studies using oxybutynin chloride in the hamster, rabbit, rat, and mouse have shown no

definite evidence of impaired fertility.

Pregnancy

Teratogenic Effects

Category B

Reproduction studies using oxybutynin chloride in the hamster, rabbit, rat, and mouse have shown no

definite evidence of impaired fertility or harm to the animal fetus. The safety of oxybutynin chloride

administered to women who are or who may become pregnant has not been established. Therefore,

oxybutynin chloride should not be given to pregnant women unless, in the judgment of the physician, the

probable clinical benefits outweigh the possible hazards.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human

milk, caution should be exercised when oxybutynin chloride is administered to a nursing woman.

Pediatric Use

The safety and efficacy of oxybutynin chloride administration have been demonstrated for pediatric

patients 5 years of age and older (see DOSAGE AND ADMINISTRATION).

The safety and efficacy of oxybutynin chloride tablets were studied in 30 children in a 24 week, open-

label trial. Patients were aged 5 to 15 years, all had symptoms of detrusor overactivity in association

with a neurological condition (e.g., spina bifida), all used clean intermittent catheterization, and all were

current users of oxybutynin chloride. Study results demonstrated that the administration of oxybutynin

chloride was associated with improvement in clinical and urodynamic parameters.

At total daily doses ranging from 5 mg to 15 mg, treatment with oxybutynin chloride tablets was

associated with an increase from baseline in mean urine volume per catheterization from 122 mL to 145

mL, an increase from baseline in mean urine volume after morning awakening from 148 mL to 168 mL,

and an increase from baseline in the mean percentage of catheterizations without a leaking episode from

43% to 61%. Urodynamic results in these patients were consistent with the clinical results. Treatment

with oxybutynin chloride tablets was associated with an increase from baseline in maximum cystometric

capacity from 230 mL to 279 mL, a decrease from baseline in mean detrusor pressure at maximum

cystometric capacity from 36 cm H

O to 33 cm H

O, and a reduction in the percentage of patients

demonstrating uninhibited detrusor contractions (of at least 15 cm H

O) from 39% to 20%.

As there is insufficient clinical data for pediatric populations under age 5, oxybutynin chloride is not

recommended for this age group.

Geriatric Use

Clinical studies of oxybutynin chloride did not include sufficient numbers of subjects age 65 and over

to determine whether they respond differently from younger patients. Other reported clinical

experience has not identified differences in responses between healthy elderly and younger patients;

however, a lower initial starting dose of 2.5 mg given 2 or 3 times a day has been recommended for the

2,3,4

frail elderly due to a prolongation of the elimination half-life from 2 to 3 hours to 5 hours.

general, dose selection for an elderly patient should be cautious, usually starting at the low end of the

dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of

concomitant disease or other drug therapy.

ADVERSE REACTIONS

The safety and efficacy of oxybutynin chloride was evaluated in a total of 199 patients in three clinical

trials. These participants were treated with oxybutynin chloride 5 to 20 mg/day for up to 6 weeks.

Table 3 shows the incidence of adverse events judged by investigators to be at least possibly related to

treatment and reported by at least 5% of patients.

Table 3: Incidence (%) of Adverse Events Reported by ≥ 5% of Patients Using Oxybutynin

Chloride (5 to 20 mg/day)

Body System

Adverse Event

Oxybutynin Chloride

(5 to 20 mg/day) (n = 199)

Infections and Infestations

Urinary tract infection

6.5%

Psychiatric Disorders

Insomnia

5.5%

Nervousness

6.5%

Nervous System Disorders

Dizziness

16.6%

Somnolence

Headache

7.5%

Eye Disorders

Blurred vision

9.6%

Gastrointestinal Disorders

Dry mouth

71.4%

Constipation

15.1%

Nausea

11.6%

Dyspepsia

Renal and Urinary Disorders

Urinary Hesitation

8.5%

Urinary Retention

The most common adverse events reported by patients receiving oxybutynin chloride 5 to 20 mg/day

were the expected side effects of anticholinergic agents. The incidence of dry mouth was dose-related.

In addition, the following adverse events were reported by 1 to < 5% of patients using oxybutynin

chloride (5 to 20 mg/day) in all studies . Infections and Infestations: nasopharyngitis, upper respiratory

tract infection, bronchitis, cystitis, fungal infection; Metabolism and Nutrition Disorders: fluid retention;

Psychiatric Disorders: confusional state; Nervous System Disorders: dysgeusia, sinus headache; Eye

Disorders: keratoconjunctivitis sicca, eye irritation; Cardiac Disorders: palpitations, sinus arrhythmia;

Vascular Disorders: flushing; Respiratory, Thoracic and Mediastinal Disorders: nasal dryness, cough,

pharyngolaryngeal pain, dry throat, sinus congestion, hoarseness, asthma, nasal congestion;

Gastrointestinal Disorders: diarrhea, abdominal pain, loose stools, flatulence, vomiting, abdominal pain

upper, dysphagia, aptyalism, eructation, tongue coated; Skin and Subcutaneous Tissue Disorders: dry skin,

pruritis; Musculoskeletal and Connective Tissue Disorders: back pain, arthralgia, pain in extremity, flank

pain; Renal and Urinary Disorders: dysuria, pollakiuria; General Disorders and Administration Site

Conditions: fatigue, edema peripheral, asthenia, pain, thirst, edema; Investigations: blood pressure

increased, blood glucose increased, blood pressure decreased; Injury, Poisoning, and Procedural

Complications: fall.

Postmarketing Surveillance

Because postmarketing adverse events are reported voluntarily from a population of uncertain size, it is

not always possible to reliably estimate their frequency or establish a causal relationship to drug

2,3,4

exposure. The following additional adverse events have been reported from worldwide postmarketing

experience with oxybutynin chloride: Psychiatric Disorders: psychotic disorder, agitation, hallucination,

memory impairment; Nervous System Disorders: convulsions; Eye Disorders: cycloplegia, mydriasis,

glaucoma; Cardiac Disorders: tachycardia, QT interval prolongation; Gastrointestinal Disorders:

decreased gastrointestinal motility; Skin and Subcutaneous Tissue Disorders: rash, decreased sweating;

Renal and Urinary Disorders: impotence; Reproductive System and Breast Disorders: suppression of

lactation; General Disorders and Administration Site Conditions: hypersensitivity reactions, including

angioedema with airway obstruction, urticaria, and face edema; rare anaphylactic reactions requiring

hospitalization for emergency treatment.

OVERDOSAGE

Treatment should be symptomatic and supportive. Activated charcoal as well as a cathartic may be

administered.

Overdosage with oxybutynin chloride has been associated with anticholinergic effects including central

nervous system excitation (e.g., restlessness, tremor, irritability, convulsions, delirium, hallucinations),

flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention. Other symptoms may

include hypotension or hypertension, respiratory failure, paralysis, and coma.

Ingestion of 100 mg oxybutynin chloride in association with alcohol has been reported in a 13-year-old

boy who experienced memory loss, and a 34-year-old woman who developed stupor, followed by

disorientation and agitation on awakening, dilated pupils, dry skin, cardiac arrhythmia, and retention of

urine. Both patients fully recovered with symptomatic treatment.

DOSAGE AND ADMINISTRATION

Adults

The usual dose is one 5 mg tablet two to three times a day. The maximum recommended dose is one 5

mg tablet four times a day. A lower starting dose of 2.5 mg two or three times a day is recommended for

the frail elderly.

Pediatric Patients Over 5 Years of Age

The usual dose is one 5 mg tablet two times a day. The maximum recommended dose is one 5 mg tablet

three times a day.

HOW SUPPLIED

Oxybutynin Chloride Tablets USP are available as follows:

5 mg – Very pale blue, round, biconvex, scored tablets. Debossed with PLIVA 456 on one side and

scored on the other side . Available in bottles of 20 NDC 68071-1875-2

bottles of 30 NDC 68071-1875-3

bottles of 60 NDC 68071-1875-6

bottles of 90 NDC 68071-1875-9

bottles of 120 NDC 68071-1875-1

bottles of 270 NDC 68071-1875-7

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as

required).

Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

REFERENCES

1. Yong C et al. Effect of Food on the Pharmacokinetics of Oxybutynin in normal subjects. Pharm Res.

1991; 8 (Suppl.): S-320.

2. Hughes KM et al. Measurement of oxybutynin and its N-desethyl metabolite in plasma, and its

application to pharmacokinetic studies in young, elderly and frail elderly volunteers. Xenobiotica.

1992; 22 (7): 859-869.

3. Ouslander J et al. Pharmacokinetics and Clinical Effects of Oxybutynin in Geriatric Patients. J. Urol.

1988; 140: 47-50.

4. Yarker Y et al. Oxybutynin: A review of its Pharmacodynamic and Pharmacokinetic Properties, and

its Therapeutic Use in Detrusor Instability. Drugs & Aging. 1995; 6(3): 243-262.

TEVA PHARMACEUTICALS USA, INC.

North Wales, PA 19454

Rev. D 9/2015

Package/Label Display Panel

Oxybutynin Chloride Tablets USP 5 mg 100s Label Text

NDC 50111 -456-01

Oxybutynin

Chloride

Tablets USP

5 mg

Rx only

100 TABLETS

TEVA

OXYBUTYNIN CHLORIDE

oxybutynin chloride tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 8 0 71-18 75(NDC:50 111-456 )

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O XYBUTYNIN CHLO RIDE (UNII: L9 F3D9 RENQ) (OXYBUTYNIN - UNII:K9 P6 MC70 9 2)

OXYBUTYNIN CHLORIDE

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CALCIUM STEARATE (UNII: 776 XM70 47L)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

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

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

Product Characteristics

Color

blue (very pale blue)

S core

2 pieces

S hap e

ROUND

S iz e

8 mm

Flavor

Imprint Code

PLIVA;456

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 0 71-18 75-2

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

0 3/29 /20 17

2

NDC:6 8 0 71-18 75-3

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

0 3/29 /20 17

3

NDC:6 8 0 71-18 75-6

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

0 3/29 /20 17

4

NDC:6 8 0 71-18 75-9

9 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/29 /20 17

5

NDC:6 8 0 71-18 75-1

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

0 3/29 /20 17

6

NDC:6 8 0 71-18 75-7

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

0 3/29 /20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 716 55

0 9 /30 /19 9 0

Labeler -

NuCare Pharmaceuticals, Inc. (010632300)

Establishment

NuCare Pharmaceuticals, Inc.

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

NuCare Pharmaceuticals, Inc.

0 10 6 3230 0

re pa c k(6 8 0 71-18 75)

Revised: 3/2017

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