DIAZEPAM

Main information

  • Trade name:
  • DIAZEPAM tablet
  • Composition:
  • DIAZEPAM 5 mg
  • Prescription type:
  • PRESCRIPTION DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DIAZEPAM tablet
    United States
  • Language:
  • English

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • Abbreviated New Drug Application
  • Last update:
  • 06-11-2017

Summary of Product characteristics: dosage, interactions, side effects

DIAZEPAM- diazepam tablet

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

----------

Diazepam

Tablets USP C-IV

Revised: June 2008

Rx only

173018

DESCRIPTION

Diazepam is a benzodiazepine derivative. The chemical name of diazepam is 7-chloro-1,3-dihydro-1-

methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound,

insoluble in water. The empirical formula is C

H ClN O and the molecular weight is 284.75. The

structural formula is as follows:

Diazepam is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam. In

addition to the active ingredient diazepam, each tablet contains the following inactive ingredients:

anhydrous lactose, magnesium stearate and microcrystalline cellulose.

Diazepam Tablets USP 5 mg also contain D&C Yellow No. 10.

Diazepam Tablets USP 10 mg also contain FD&C Blue No. 1.

CLINICAL PHARMACOLOGY

Diazepam is a benzodiazepine that exerts anxiolytic, sedative, muscle-relaxant, anticonvulsant and

amnestic effects. Most of these effects are thought to result from a facilitation of the action of gamma

aminobutyric acid (GABA), an inhibitory neurotransmitter in the central nervous system.

Pharmacokinetics

Absorption

After oral administration >90% of diazepam is absorbed and the average time to achieve peak plasma

concentrations is 1 – 1.5 hours with a range of 0.25 to 2.5 hours. Absorption is delayed and decreased

when administered with a moderate fat meal. In the presence of food mean lag times are approximately

45 minutes as compared with 15 minutes when fasting. There is also an increase in the average time to

achieve peak concentrations to about 2.5 hours in the presence of food as compared with 1.25 hours

when fasting. This results in an average decrease in C

of 20% in addition to a 27% decrease in AUC

(range 15% to 50%) when administered with food.

Distribution

Diazepam and its metabolites are highly bound to plasma proteins (diazepam 98%). Diazepam and its

metabolites cross the blood-brain and placental barriers and are also found in breast milk in

concentrations approximately one tenth of those in maternal plasma (days 3 to 9 post-partum). In young

healthy males, the volume of distribution at steady-state is 0.8 to 1.0 L/kg. The decline in the plasma

concentration-time profile after oral administration is biphasic. The initial distribution phase has a half-

life of approximately 1 hour, although it may range up to >3 hours.

Metabolism

Diazepam is N-demethylated by CYP3A4 and 2C19 to the active metabolite N-desmethyldiazepam, and

is hydroxylated by CYP3A4 to the active metabolite temazepam. N-desmethyldiazepam and temazepam

are both further metabolized to oxazepam. Temazepam and oxazepam are largely eliminated by

glucuronidation.

Elimination

The initial distribution phase is followed by a prolonged terminal elimination phase (half-life up to 48

hours). The terminal elimination half-life of the active metabolite N-desmethyldiazepam is up to 100

hours. Diazepam and its metabolites are excreted mainly in the urine, predominantly as their glucuronide

conjugates. The clearance of diazepam is 20 to 30 mL/min in young adults. Diazepam accumulates upon

multiple dosing and there is some evidence that the terminal elimination half-life is slightly prolonged.

Pharmacokinetics in Special Populations

Children

In children 3 - 8 years old the mean half-life of diazepam has been reported to be 18 hours.

Newborns

In full term infants, elimination half-lives around 30 hours have been reported, with a longer average

half-life of 54 hours reported in premature infants of 28 - 34 weeks gestational age and 8 - 81 days

post-partum. In both premature and full term infants the active metabolite desmethyldiazepam shows

evidence of continued accumulation compared to children. Longer half-lives in infants may be due to

incomplete maturation of metabolic pathways.

Geriatric

Elimination half-life increases by approximately 1 hour for each year of age beginning with a half-life

of 20 hours at 20 years of age. This appears to be due to an increase in volume of distribution with age

and a decrease in clearance. Consequently, the elderly may have lower peak concentrations, and on

multiple dosing higher trough concentrations. It will also take longer to reach steady-state. Conflicting

information has been published on changes of plasma protein binding in the elderly. Reported changes

in free drug may be due to significant decreases in plasma proteins due to causes other than simply

aging.

Hepatic Insufficiency

In mild and moderate cirrhosis, average half-life is increased. The average increase has been variously

reported from 2-fold to 5-fold, with individual half-lives over 500 hours reported. There is also an

increase in volume of distribution, and average clearance decreases by almost half. Mean half-life is

also prolonged with hepatic fibrosis to 90 hours (range 66 - 104 hours), with chronic active hepatitis

to 60 hours (range 26 - 76 hours), and with acute viral hepatitis to 74 hours (range 49 - 129). In chronic

active hepatitis, clearance is decreased by almost half.

INDICATIONS

Diazepam Tablets USP are indicated for the management of anxiety disorders or for the short-term

relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually

does not require treatment with an anxiolytic.

In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation,

tremor, impending or acute delirium tremens and hallucinosis.

Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local

pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by

upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; and stiff-man

syndrome.

Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as

the sole therapy.

The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by

systematic clinical studies. The physician should periodically reassess the usefulness of the drug for

the individual patient.

CONTRAINDICATIONS

Diazepam Tablets USP are contraindicated in patients with a known hypersensitivity to this drug and,

because of lack of sufficient clinical experience, in pediatric patients under 6 months of age. Diazepam

is also contraindicated in patients with myasthenia gravis, severe respiratory insufficiency, severe

hepatic insufficiency, and sleep apnea syndrome. It may be used in patients with open-angle glaucoma

who are receiving appropriate therapy, but is contraindicated in acute narrow-angle glaucoma.

WARNINGS

Diazepam is not recommended in the treatment of psychotic patients and should not be employed instead

of appropriate treatment.

Since diazepam has a central nervous system depressant effect, patients should be advised against the

simultaneous ingestion of alcohol and other CNS-depressant drugs during diazepam therapy.

As with other agents which have anticonvulsant activity, when diazepam is used as an adjunct in treating

convulsive disorders, the possibility of an increase in the frequency and/or severity of grand mal

seizures may require an increase in the dosage of standard anticonvulsant medication. Abrupt withdrawal

of diazepam in such cases may also be associated with a temporary increase in the frequency and/or

severity of seizures.

Pregnancy

An increased risk of congenital malformations and other developmental abnormalities associated

with the use of benzodiazepine drugs during pregnancy has been suggested. There may also be

non-teratogenic risks associated with the use of benzodiazepines during pregnancy. There have

been reports of neonatal flaccidity, respiratory and feeding difficulties, and hypothermia in

children born to mothers who have been receiving benzodiazepines late in pregnancy. In

addition, children born to mothers receiving benzodiazepines on a regular basis late in pregnancy

may be at some risk of experiencing withdrawal symptoms during the postnatal period.

Diazepam has been shown to be teratogenic in mice and hamsters when given orally at daily

doses of 100 mg/kg or greater (approximately eight times the maximum recommended human

dose [MRHD=1 mg/kg/day] or greater on a mg/m2 basis). Cleft palate and encephalopathy are the

most common and consistently reported malformations produced in these species by

administration of high, maternally toxic doses of diazepam during organogenesis. Rodent studies

have indicated that prenatal exposure to diazepam doses similar to those used clinically can

produce long-term changes in cellular immune responses, brain neurochemistry, and behavior.

In general, the use of diazepam in women of childbearing potential, and more specifically during

known pregnancy, should be considered only when the clinical situation warrants the risk to the

fetus. The possibility that a woman of childbearing potential may be pregnant at the time of

institution of therapy should be considered. If this drug is used during pregnancy, or if the patient

becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to

the fetus. Patients should also be advised that if they become pregnant during therapy or intend to

become pregnant they should communicate with their physician about the desirability of

discontinuing the drug.

Labor and Delivery

Special care must be taken when diazepam is used during labor and delivery, as high single doses may

produce irregularities in the fetal heart rate and hypotonia, poor sucking, hypothermia, and moderate

respiratory depression in the neonates. With newborn infants it must be remembered that the enzyme

system involved in the breakdown of the drug is not yet fully developed (especially in premature

infants).

Nursing Mothers

Diazepam passes into breast milk. Breastfeeding is therefore not recommended in patients receiving

diazepam.

PRECAUTIONS

General

If diazepam is to be combined with other psychotropic agents or anticonvulsant drugs, careful

consideration should be given to the pharmacology of the agents to be employed - particularly with

known compounds that may potentiate the action of diazepam, such as phenothiazines, narcotics,

barbiturates, MAO inhibitors and other antidepressants (see Drug Interactions).

The usual precautions are indicated for severely depressed patients or those in whom there is any

evidence of latent depression or anxiety associated with depression, particularly the recognition that

suicidal tendencies may be present and protective measures may be necessary.

Psychiatric and paradoxical reactions are known to occur when using benzodiazepines (see ADVERSE

REACTIONS). Should this occur, use of the drug should be discontinued. These reactions are more

likely to occur in children and the elderly.

A lower dose is recommended for patients with chronic respiratory insufficiency, due to the risk of

respiratory depression.

Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug

abuse (see DRUG ABUSE AND DEPENDENCE ).

In debilitated patients, it is recommended that the dosage be limited to the smallest effective amount to

preclude the development of ataxia or oversedation (2 mg to 2.5 mg once or twice daily, initially, to be

increased gradually as needed and tolerated).

Some loss of response to the effects of benzodiazepines may develop after repeated use of diazepam

for a prolonged time.

Information for Patients

To assure the safe and effective use of benzodiazepines, patients should be informed that, since

benzodiazepines may produce psychological and physical dependence, it is advisable that they consult

with their physician before either increasing the dose or abruptly discontinuing this drug. The risk of

dependence increases with duration of treatment; it is also greater in patients with a history of alcohol

or drug abuse.

Patients should be advised against the simultaneous ingestion of alcohol and other CNS-depressant

drugs during diazepam therapy. As is true of most CNS-acting drugs, patients receiving diazepam

should be cautioned against engaging in hazardous occupations requiring complete mental alertness,

such as operating machinery or driving a motor vehicle.

Drug Interactions

Centrally Acting Agents

If diazepam is to be combined with other centrally acting agents, careful consideration should be given

to the pharmacology of the agents employed particularly with compounds that may potentiate or be

potentiated by the action of diazepam, such as phenothiazines, antipsychotics, anxiolytics/sedatives,

hypnotics, anticonvulsants, narcotic analgesics, anesthetics, sedative antihistamines, narcotics,

barbiturates, MAO inhibitors and other antidepressants.

Alcohol

Concomitant use with alcohol is not recommended due to enhancement of the sedative effect.

Antacids

Diazepam peak concentrations are 30% lower when antacids are administered concurrently. However,

there is no effect on the extent of absorption. The lower peak concentrations appear due to a slower rate

of absorption, with the time required to achieve peak concentrations on average 20 - 25 minutes greater

in the presence of antacids. However, this difference was not statistically significant.

Compounds Which Inhibit Certain Hepatic Enzymes

There is a potentially relevant interaction between diazepam and compounds which inhibit certain

hepatic enzymes (particularly cytochrome P450 3A and 2C19). Data indicate that these compounds

influence the pharmacokinetics of diazepam and may lead to increased and prolonged sedation. At

present, this reaction is known to occur with cimetidine, ketoconazole, fluvoxamine, fluoxetine, and

omeprazole.

Phenytoin

There have also been reports that the metabolic elimination of phenytoin is decreased by diazepam.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In studies in which mice and rats were administered diazepam in the diet at a dose of 75 mg/kg/day

(approximately 6 and 12 times, respectively, the maximum recommended human dose [MRHD=1

mg/kg/day] on a mg/m2 basis) for 80 and 104 weeks, respectively, an increased incidence of liver

tumors was observed in males of both species. The data currently available are inadequate to determine

the mutagenic potential of diazepam. Reproduction studies in rats showed decreases in the number of

pregnancies and in the number of surviving offspring following administration of an oral dose of 100

mg/kg/day (approximately 16 times the MRHD on a mg/m2 basis) prior to and during mating and

throughout gestation and lactation. No adverse effects on fertility or offspring viability were noted at a

dose of 80 mg/kg/day (approximately 13 times the MRHD on a mg/m basis).

Pregnancy

Category D (see WARNINGS: Pregnancy).

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 6 months have not been established.

Geriatric Use

In elderly patients, it is recommended that the dosage be limited to the smallest effective amount to

preclude the development of ataxia or oversedation (2 mg to 2.5 mg once or twice daily, initially to be

increased gradually as needed and tolerated).

Extensive accumulation of diazepam and its major metabolite, desmethyldiazepam, has been noted

following chronic administration of diazepam in healthy elderly male subjects. Metabolites of this drug

are known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in

patients with impaired renal function. Because elderly patients are more likely to have decreased renal

function, care should be taken in dose selection, and it may be useful to monitor renal function.

Hepatic Insufficiency

Decreases in clearance and protein binding, and increases in volume of distribution and half-life has

been reported in patients with cirrhosis. In such patients, a 2- to 5- fold increase in mean half-life has

been reported. Delayed elimination has also been reported for the active metabolite desmethyldiazepam.

Benzodiazepines are commonly implicated in hepatic encephalopathy. Increases in half-life have also

been reported in hepatic fibrosis and in both acute and chronic hepatitis (see CLINICAL

PHARMACOLOGY: Pharmacokinetics in Special Populations: Hepatic Insufficiency ).

ADVERSE REACTIONS

Side effects most commonly reported were drowsiness, fatigue, muscle weakness, and ataxia. The

following have also been reported:

Central Nervous System: confusion, depression, dysarthria, headache, slurred speech, tremor, vertigo

Gastrointestinal System: constipation, nausea, gastrointestinal disturbances

Special Senses: blurred vision, diplopia, dizziness

Cardiovascular System:hypotension

Psychiatric and Paradoxical Reactions: stimulation, restlessness, acute hyperexcited states, anxiety,

agitation, aggressiveness, irritability, rage, hallucinations, psychoses, delusions, increased muscle

spasticity, insomnia, sleep disturbances, and nightmares. Inappropriate behavior and other adverse

behavioral effects have been reported when using benzodiazepines. Should these occur, use of the drug

should be discontinued. They are more likely to occur in children and in the elderly.

Urogenital System: incontinence, changes in libido, urinary retention

Skin and Appendages: skin reactions

Laboratories: elevated transaminases and alkaline phosphatase

Other: changes in salivation, including dry mouth, hypersalivation

Antegrade amnesia may occur using therapeutic dosages, the risk increasing at higher dosages.

Amnestic effects may be associated with inappropriate behavior.

Minor changes in EEG patterns, usually low-voltage fast activity, have been observed in patients during

and after diazepam therapy and are of no known significance.

Because of isolated reports of neutropenia and jaundice, periodic blood counts and liver function tests

are advisable during long-term therapy.

DRUG ABUSE AND DEPENDENCE

Diazepam is subject to Schedule IV control under the Controlled Substances Act of 1970. Abuse and

dependence of benzodiazepines have been reported. Addiction-prone individuals (such as drug addicts

or alcoholics) should be under careful surveillance when receiving diazepam or other psychotropic

agents because of the predisposition of such patients to habituation and dependence. Once physical

dependence to benzodiazepines has developed, termination of treatment will be accompanied by

withdrawal symptoms. The risk is more pronounced in patients on long-term therapy.

Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol have occurred

following abrupt discontinuance of diazepam. These withdrawal symptoms may consist of tremor,

abdominal and muscle cramps, vomiting, sweating, headache, muscle pain, extreme anxiety, tension,

restlessness, confusion and irritability. In severe cases, the following symptoms may occur:

derealization, depersonalization, hyperacusis, numbness and tingling of the extremities, hypersensitivity

to light, noise and physical contact, hallucinations or epileptic seizures. The more severe withdrawal

symptoms have usually been limited to those patients who had received excessive doses over an

extended period of time. Generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have

been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic

levels for several months. Consequently, after extended therapy, abrupt discontinuation should generally

be avoided and a gradual dosage tapering schedule followed.

Chronic use (even at therapeutic doses) may lead to the development of physical dependence:

discontinuation of the therapy may result in withdrawal or rebound phenomena.

Rebound Anxiety: A transient syndrome whereby the symptoms that led to treatment with diazepam recur

in an enhanced form. This may occur upon discontinuation of treatment. It may be accompanied by other

reactions including mood changes, anxiety, and restlessness.

Since the risk of withdrawal phenomena and rebound phenomena is greater after abrupt discontinuation

of treatment, it is recommended that the dosage be decreased gradually.

OVERDOSAGE

Overdose of benzodiazepines is usually manifested by central nervous system depression ranging from

drowsiness to coma. In mild cases, symptoms include drowsiness, confusion, and lethargy. In more

serious cases, symptoms may include ataxia, diminished reflexes, hypotonia, hypotension, respiratory

depression, coma (rarely), and death (very rarely). Overdose of benzodiazepines in combination with

other CNS depressants (including alcohol) may be fatal and should be closely monitored.

Management of Overdosage

Following overdose with oral benzodiazepines, general supportive measures should be employed

including the monitoring of respiration, pulse, and blood pressure. Vomiting should be induced (within

1 hour) if the patient is conscious. Gastric lavage should be undertaken with the airway protected if the

patient is unconscious. Intravenous fluids should be administered. If there is no advantage in emptying

the stomach, activated charcoal should be given to reduce absorption. Special attention should be paid

to respiratory and cardiac function in intensive care. General supportive measures should be employed,

along with intravenous fluids, and an adequate airway maintained. Should hypotension develop, treatment

may include intravenous fluid therapy, repositioning, judicious use of vasopressors appropriate to the

clinical situation, if indicated, and other appropriate countermeasures. Dialysis is of limited value.

As with the management of intentional overdosage with any drug, it should be considered that multiple

agents may have been ingested.

Flumazenil, a specific benzodiazepine-receptor antagonist, is indicated for the complete or partial

reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with

a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures

should be instituted to secure airway, ventilation and intravenous access. Flumazenil is intended as an

adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with

flumazenil should be monitored for resedation, respiratory depression and other residual

benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a

risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine

users and in cyclic antidepressant overdose. Caution should be observed in the use of flumazenil in

epileptic patients treated with benzodiazepines. The complete flumazenil package insert, including

CONTRAINDICATIONS , WARNINGS , and PRECAUTIONS, should be consulted prior to use.

Withdrawal symptoms of the barbiturate type have occurred after the discontinuation of benzodiazepines

(see DRUG ABUSE AND DEPENDENCE).

DOSAGE AND ADMINISTRATION

Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given

below will meet the needs of most patients, there will be some who may require higher doses. In such

cases dosage should be increased cautiously to avoid adverse effects.

ADULTS:

USUAL DAILY DOSE:

Management of Anxiety Disorders and relief of Symptoms of

Anxiety.

Depending on severity of symptoms —

2 mg to 10 mg, 2 to 4 times daily

Symptomatic Relief in Acute Alcohol Withdrawal.

10 mg, 3 or 4 times during the first 24

hours, reducing to 5 mg, 3 or 4 times

daily as needed

Adjunctively for Relief of Skeletal Muscle Spasm.

2 mg to 10 mg, 3 or 4 times daily

Adjunctively in Convulsive Disorders.

2 mg to 10 mg, 2 to 4 times daily

Geriatric Patients, or in the presence of debilitating

disease.

2 mg to 2.5 mg, 1 or 2 times daily

initially; increase gradually as needed

and tolerated

PEDIATRIC PATIENTS:

Because of varied responses to CNS-acting drugs, initiate

therapy with lowest dose and increase as required. Not for use

in children under 6 months.

1 mg to 2.5 mg, 3 or 4 times daily

initially; increase gradually as needed

and tolerated

HOW SUPPLIED

Diazepam Tablets USP 2 mg are scored, round, white tablets imprinted DAN 5621 and 2.

Diazepam Tablets USP 5 mg are scored, round, yellow tablets imprinted DAN 5619 and 5.

Diazepam Tablets USP 10 mg are scored, round, blue tablets imprinted DAN 5620 and 10.

Dispense in tight, light-resistant container with child-resistant closure.

Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]

Manufactured by:

Watson Laboratories, Inc.Corona, CA 92880 USA

Distributed by:

Watson Pharma, Inc.Corona, CA 92880 USA

Revised: June 2008 0608B

173018

Image of 5 mg Label

Image of 10mg Label

DIAZEPAM

diazepam tablet

Product Information

Product T ype

HUMAN PRESCRIPTION

DRUG

Ite m Code (Source )

NDC:35356 -

716 (NDC:0 59 1-56 19 )

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIAZEPAM (UNII: Q3JTX2Q7TU) (DIAZEPAM - UNII:Q3JTX2Q7TU)

DIAZEPAM

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

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

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

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

Product Characteristics

Color

YELLOW

S core

2 pieces

S hap e

ROUND

S iz e

8 mm

Flavor

Imprint Code

DAN;56 19 ;5

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:35356 -716 -10

10 in 1 BOTTLE, PLASTIC

2

NDC:35356 -716 -15

15 in 1 BOTTLE, PLASTIC

3

NDC:35356 -716 -20

20 in 1 BOTTLE, PLASTIC

4

NDC:35356 -716 -0 2

2 in 1 BOTTLE, PLASTIC

5

NDC:35356 -716 -0 5

5 in 1 BOTTLE, PLASTIC

6

NDC:35356 -716 -6 0

6 0 in 1 BOTTLE, PLASTIC

7

NDC:35356 -716 -9 0

9 0 in 1 BOTTLE, PLASTIC

8

NDC:35356 -716 -30

30 in 1 BOTTLE, PLASTIC

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 71135

0 2/0 3/19 8 7

DIAZEPAM

diazepam tablet

Product Information

Product T ype

HUMAN PRESCRIPTION

DRUG

Ite m Code (Source )

NDC:35356 -

724(NDC:0 59 1-56 20 )

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIAZEPAM (UNII: Q3JTX2Q7TU) (DIAZEPAM - UNII:Q3JTX2Q7TU)

DIAZEPAM

10 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

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

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

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

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

Product Characteristics

Color

BLUE

S core

2 pieces

S hap e

ROUND

S iz e

8 mm

Flavor

Imprint Code

DAN;56 20 ;10

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:35356 -724-0 2

2 in 1 BOTTLE, PLASTIC

2

NDC:35356 -724-20

20 in 1 BOTTLE, PLASTIC

3

NDC:35356 -724-30

30 in 1 BOTTLE, PLASTIC

4

NDC:35356 -724-6 0

6 0 in 1 BOTTLE, PLASTIC

5

NDC:35356 -724-9 0

9 0 in 1 BOTTLE, PLASTIC

6

NDC:35356 -724-0 0

10 0 in 1 BOTTLE, PLASTIC

7

NDC:35356 -724-0 1

120 in 1 BOTTLE, PLASTIC

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 71136

0 2/0 3/19 8 7

Labeler -

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC (831276758)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Lake Erie Medical & Surgical Supply DBA Quality Care Pro ducts LLC

8 31276 758

repack(35356 -716 , 35356 -724)

Revised: 11/2012