LITHIUM CARBONATE - lithium carbonate capsule

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

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Active ingredient:
LITHIUM CARBONATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8H8Z5UER66)
Available from:
Alembic Pharmaceuticals Limited
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Lithium is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-III) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology.  Lithium is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks. Lithium should generally not be given to patients with significant renal or cardiovascular disease, severe debilitation or dehydration, or sodium depletion, and to patients receiving diuretics, since the risk of lithium toxicity is very high in such patients. If the
Product summary:
Lithium Carbonate Capsules USP 150 mg opaque buff/opaque buff colored capsules (size 4) (Identified A 101) NDC 46708-303-30: Bottles of 30 capsules. NDC 46708-303-31: Bottles of 100 capsules. NDC 46708-303-71: Bottles of 500 capsules. NDC 46708-303-91: Bottles of 1000 capsules. 300 mg opaque light pink/opaque light pink colored capsules (size 2) (Identified A 102) NDC 46708-304-30: Bottles of 30 capsules. NDC 46708-304-31: Bottles of 100 capsules. NDC 46708-304-71: Bottles of 500 capsules. NDC 46708-304-91: Bottles of 1000 capsules. 600 mg opaque pink/opaque buff colored capsules (size 0) (Identified A 103) NDC 46708-305-30: Bottles of 30 capsules. NDC 46708-305-31: Bottles of 100 capsules. NDC 46708-305-71: Bottles of 500 capsules. Store and Dispense: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container as defined in the USP/NF.  Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Village Panelav, P. O. Tajpura, Near Baska, Taluka-Halol, Panchmahal, Gujarat, India.   Revised: 11/2011
Authorization status:
Abbreviated New Drug Application
Authorization number:
46708-303-30, 46708-303-31, 46708-303-71, 46708-303-91, 46708-304-30, 46708-304-31, 46708-304-71, 46708-304-91, 46708-305-30, 46708-305-31, 46708-305-71

LITHIUM CARBONATE - lithium carbonate capsule

Alembic Pharmaceuticals Limited

----------

Lithium Carbonate Capsules USP

Rx Only

WARNING

Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to

therapeutic levels. Facilities for prompt and accurate serum lithium determinations should be

available before initiating therapy (see DOSAGE AND ADMINISTRATION).

DESCRIPTION

Each capsule for oral administration contains:

Lithium Carbonate USP . . . . . . . . . . 150 mg, 300 mg or 600 mg

Inactive Ingredients:

The capsules contain talc, gelatin, FD&C Red No. 40, titanium dioxide, D&C Yellow No. 10, FD&C

Yellow No. 6, and the imprinting ink contains black iron oxide, & Pharmaceutical glaze.

Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an

emission line at 671 nm on the flame photometer.

Lithium Carbonate is a white, light, alkaline powder with molecular formula Li

CO and molecular

weight 73.89.

CLINICAL PHARMACOLOGY

Preclinical studies have shown that lithium alters sodium transport in nerve and muscle cells and effects

a shift toward intraneuronal metabolism of catecholamines, but the specific biochemical mechanism of

lithium action in mania is unknown.

INDICATIONS AND USAGE

Lithium is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic

(DSM-III) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology.

Lithium is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar

Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of

those episodes which may occur.

Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep,

flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given

to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology

within 1 to 3 weeks.

CONTRAINDICATIONS

Lithium should generally not be given to patients with significant renal or cardiovascular disease,

severe debilitation or dehydration, or sodium depletion, and to patients receiving diuretics, since the

risk of lithium toxicity is very high in such patients. If the psychiatric indication is life-threatening, and

if such a patient fails to respond to other measures, lithium treatment may be undertaken with extreme

caution, including daily serum lithium determinations and adjustment to the usually low doses ordinarily

tolerated by these individuals. In such instances, hospitalization is a necessity.

WARNINGS

Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic

levels (see DOSAGE AND ADMINISTRATION).

Unmasking of Brugada Syndrome

There have been postmarketing reports of a possible association between treatment with lithium and the

unmasking of Brugada Syndrome. Brugada Syndrome is a disorder characterized by abnormal

electrocardiographic (ECG) findings and a risk of sudden death. Lithium should generally be avoided in

patients with Brugada Syndrome or those suspected of having Brugada Syndrome. Consultation with a

cardiologist is recommended if: (1) treatment with lithium is under consideration for patients suspected

of having Brugada Syndrome or patients who have risk factors for Brugada Syndrome, e.g., unexplained

syncope, a family history of Brugada Syndrome, or a family history of sudden unexplained death before

the age of 45 years, (2) patients who develop unexplained syncope or palpitations after starting lithium

therapy.

Pregnancy

Lithium may cause fetal harm when administered to a pregnant woman. There have been reports of

lithium having adverse effects on nidations in rats, embryo viability in mice, and metabolism in-vitro of

rat testis and human spermatozoa have been attributed to lithium, as have teratogenicity in submammalian

species and cleft palates in mice. Studies in rats, rabbits and monkeys have shown no evidence of

lithium-induced teratology. Data from lithium birth registries suggest an increase in cardiac and other

anomalies, especially Ebstein’s anomaly. If the patient becomes pregnant while taking lithium, she

should be apprised of the potential risk to the fetus. If possible, lithium should be withdrawn for at least

the first trimester unless it is determined that this would seriously endanger the mother.

Lithium-Induced Renal Effects

Chronic lithium therapy may be associated with diminution of renal concentrating ability, occasionally

presenting as nephrogenic diabetes insipidus, with polyuria and polydipsia. Such patients should be

carefully managed to avoid dehydration with resulting lithium retention and toxicity. This condition is

usually reversible when lithium is discontinued.

Morphologic changes with glomerular and interstitial fibrosis and nephron-atrophy have been reported

in patients on chronic lithium therapy. Morphologic changes have also been seen in bipolar patients

never exposed to lithium. The relationship between renal functional and morphologic changes and their

association with lithium therapy has not been established.

When kidney function is assessed, for baseline data prior to starting lithium therapy or thereafter,

routine urinalysis and other tests may be used to evaluate tubular function (e.g., urine specific gravity or

osmolality following a period of water deprivation, or 24-hour urine volume) and glomerular function

(e.g., serum creatinine or creatinine clearance). During lithium therapy, progressive or sudden changes

in renal function, even within the normal range, indicate the need for reevaluation of treatment.

PRECAUTIONS

General

The ability to tolerate lithium is greater during the acute manic phase and decreases when manic

symptoms subside (see DOSAGE AND ADMINISTRATION).

The distribution space of lithium approximates that of total body water. Lithium is primarily excreted in

urine with insignificant excretion in feces. Renal excretion of lithium is proportional to its plasma

concentration. The half-life of elimination of lithium is approximately 24 hours. Lithium decreases

sodium reabsorption by the renal tubules which could lead to sodium depletion. Therefore, it is

essential for the patient to maintain a normal diet, including salt, and an adequate fluid intake (2500-3000

mL) at least during the initial stabilization period. Decreased tolerance to lithium has been reported to

ensue from protracted sweating or diarrhea and, if such occur, supplemental fluid and salt should be

administered.

In addition to sweating and diarrhea, concomitant infection with elevated temperatures may also

necessitate a temporary reduction or cessation of medication.

Previously existing underlying thyroid disorders do not necessarily constitute a contraindication to

lithium treatment; where hypothyroidism exists, careful monitoring of thyroid function during lithium

stabilization and maintenance allows for correction of changing thyroid parameters, if any. Where

hypothyroidism occurs during lithium stabilization and maintenance, supplemental thyroid treatment may

be used.

Information for the Patients

A condition known as Brugada Syndrome may pre-exist and be unmasked by lithium therapy. Brugada

Syndrome is a heart disorder characterized by abnormal electrocardiographic (ECG) findings and risk

of sudden death. Patients should be advised to seek immediate emergency assistance if they experience

fainting, lightheadedness, abnormal heart beats, or shortness of breath.

Outpatients and their families should be warned that the patient must discontinue lithium therapy and

contact his physician if such clinical signs of lithium toxicity as diarrhea, vomiting, tremor, mild ataxia,

drowsiness, or muscular weakness occur.

Lithium may impair mental and/or physical abilities. Caution patients about activities requiring alertness

(e.g., operating vehicles or machinery).

Drug Interactions

Combined Use of Haloperidol and Lithium.

An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and

confusion, extrapyramidal symptoms, leucocytosis, elevated serum enzymes, BUN and FBS) followed

by irreversible brain damage has occurred in a few patients treated with lithium plus haloperidol. A

causal relationship between these events and the concomitant administration of lithium and haloperidol

has not been established; however, patients receiving such combined therapy should be monitored

closely for early evidence of neurological toxicity and treatment discontinued promptly if such signs

appear.

The possibility of similar adverse interactions with other antipsychotic medication exists.

Lithium may prolong the effects of neuromuscular blocking agents. Therefore, neuromuscular blocking

agents should be given with caution to patients receiving lithium.

Caution should be used when lithium and diuretics or angiotensin converting enzyme (ACE) inhibitors

are used concomitantly because sodium loss may reduce the renal clearance of lithium and increase

serum lithium levels with risk of lithium toxicity. When such combinations are used, the lithium dosage

may need to be decreased, and more frequent monitoring of lithium plasma levels is recommended.

Non-Steroidal Anti-Inflammatory Drugs (NSAIDS)

Lithium levels should be closely monitored when patients initiate or discontinue NSAID use. In some

cases, lithium toxicity has resulted from interactions between an NSAID and lithium. Indomethacin and

piroxicam have been reported to increase significantly steady-state plasma lithium concentrations.

There is also evidence that other nonsteroidal anti-inflammatory agents, including the selective

cyclooxygenase-2 (COX-2) inhibitors, have the same effect. In a study conducted in healthy subjects,

mean steady-state lithium plasma levels increased approximately 17% in subjects receiving lithium 450

mg BID with celecoxib 200 mg BID as compared to subjects receiving lithium alone.

Pregnancy, Teratogenic Effects

Teratogenic Effects: Pregnancy Category D:

See WARNINGS section.

Nursing Mothers

Lithium is excreted in human milk. Nursing should not be undertaken during lithium therapy except in

rare and unusual circumstances where, in the view of the physician, the potential benefits to the mother

outweigh possible hazards to the child.

Usage in Children

Since information regarding the safety and effectiveness of lithium in children under 12 years of age is

not available, its use in such patients is not recommended at this time. There has been a report of a

transient syndrome of acute dystonia and hyperreflexia occurring in a 15 kg child who ingested 300 mg

of lithium carbonate.

ADVERSE REACTIONS

Lithium Toxicity

The likelihood of toxicity increases with increasing serum lithium levels. Serum lithium levels greater

than 1.5 mEq/L carry a greater risk than lower levels. However, patients sensitive to lithium may exhibit

toxic signs at serum levels below 1.5 mEq/L.

Diarrhea, vomiting, drowsiness, muscular weakness and lack of coordination may be early signs of

lithium toxicity, and can occur at lithium levels below 2 mEq/L. At higher levels, giddiness, ataxia,

blurred vision, tinnitus and a large output of dilute urine may be seen. Serum lithium levels above 3

mEq/L may produce a complex clinical picture involving multiple organs and organ systems. Serum

lithium levels should not be permitted to exceed 2 mEq/L during the acute treatment phase.

Fine hand tremor, polyuria and mild thirst may occur during initial therapy for the acute manic phase, and

may persist throughout treatment. Transient and mild nausea and general discomfort may also appear

during the first few days of lithium administration.

These side effects are an inconvenience rather than a disabling condition, and usually subside with

continued treatment or a temporary reduction or cessation of dosage. If persistent, a cessation of dosage

is indicated.

The following adverse reactions have been reported and do not appear to be directly related to serum

lithium levels.

Neuromuscular

Tremor, muscle hyperirritability (fasciculations, twitching, clonic movements of whole limbs), ataxia,

choreo-athetotic movements, hyperactive deep tendon reflexes.

Central Nervous System

Blackout spells, epileptiform seizures, slurred speech, dizziness, vertigo, incontinence of urine or

feces, somnolence, psychomotor retardation, restlessness, confusion, stupor, coma, acute dystonia,

downbeat nystagmus.

Cardiovascular

Cardiac arrhythmia, hypotension, peripheral circulatory collapse, sinus node dysfunction with severe

bradycardia (which may result in syncope), unmasking of Brugada Syndrome (See WARNINGS:

Unmasking of Brugada Syndromeand PRECAUTIONS: Information for the Patients).

Neurological

Cases of pseudotumor cerebri (increased intracranial pressure and papilledema) have been reported

with lithium use. If undetected, this condition may result in enlargement of the blind spot, constriction of

visual fields and eventual blindness due to optic atrophy. Lithium should be discontinued, if clinically

possible, if this syndrome occurs.

Gastrointestinal

Anorexia, nausea, vomiting, diarrhea.

Genitourinary

Albuminuria, oliguria, polyuria, glycosuria.

Dermatologic

Drying and thinning of hair, anesthesia of skin, chronic folliculitis, xerosis cutis, alopecia and

exacerbation of psoriasis.

Autonomic Nervous System

Blurred vision, dry mouth.

Thyroid Abnormalities

Euthyroid goiter and/or hypothyroidism (including myxedema) accompanied by lower T3 and T4. Iodine

131 uptake may be elevated. (See PRECAUTIONS). Paradoxically, rare cases of hyperthyroidism have

been reported.

EEG Changes

Diffuse slowing, widening of frequency spectrum, potentiation and disorganization of background

rhythm.

EKG Changes

Reversible flattening, isoelectricity or inversion of T-waves.

Miscellaneous

Fatigue, lethargy, transient scotomata, dehydration, weight loss, tendency to sleep.

Miscellaneous Reactions Unrelated to Dosage are:

Transient electroencephalographic and electrocardiographic changes, leucocytosis, headache, diffuse

non-toxic goiter with or without hypothyroidism, transient hyperglycemia, generalized pruritis with or

without rash, cutaneous ulcers, albuminuria, worsening of organic brain syndromes, excessive weight

gain, edematous swelling of ankles or wrists, and thirst or polyuria, sometimes resembling diabetes

insipidus, and metallic taste.

A single report has been received of the development of painful discoloration of fingers and toes and

coldness of the extremities within one day of the starting of treatment of lithium. The mechanism

through which these symptoms (resembling Raynaud’s Syndrome) developed is not known. Recovery

followed discontinuance.

OVERDOSAGE

The toxic levels for lithium are close to the therapeutic levels. It is therefore important that patients and

their families be cautioned to watch for early symptoms and to discontinue the drug and inform the

physician should they occur. Toxic symptoms are listed in detail under ADVERSE REACTIONS.

Treatment

No specific antidote for lithium poisoning is known. Early symptoms of lithium toxicity can usually be

treated by reduction of cessation of dosage of the drug and resumption of the treatment at a lower dose

after 24 to 48 hours. In severe cases of lithium poisoning, the first and foremost goal of treatment

consists of elimination of this ion from the patient.

Treatment is essentially the same as that used in barbiturate poisoning: 1) gastric lavage, 2) correction

of fluid and electrolyte imbalance and 3) regulation of kidney functioning. Urea, mannitol, and

aminophylline all produce significant increases in lithium excretion. Hemodialysis is an effective and

rapid means of removing the ion from the severely toxic patient. Infection prophylaxis, regular chest X-

rays, and preservation of adequate respiration are essential.

DOSAGE AND ADMINISTRATION

Acute Mania

Optimal patient response to Lithium Carbonate usually can be established and maintained with 600 mg

t.i.d. Such doses will normally produce an effective serum lithium level ranging between 1 and 1.5

mEq/L. Dosage must be individualized according to serum levels and clinical response. Regular

monitoring of the patient’s clinical state and of serum lithium levels is necessary. Serum levels should

be determined twice per week during the acute phase, and until the serum level and clinical condition of

the patient have been stabilized.

Long-Term Control

The desirable serum lithium levels are 0.6 to 1.2 mEq/L. Dosage will vary from one individual to

another, but usually 300 mg of Lithium Carbonate t.i.d. or q.i.d., will maintain this level. Serum lithium

levels in uncomplicated cases receiving maintenance therapy during remission should be monitored at

least every two months.

Patients abnormally sensitive to lithium may exhibit toxic signs at serum levels of 1 to 1.5 mEq/L.

Elderly patients often respond to reduced dosage, and may exhibit signs of toxicity at serum levels

ordinarily tolerated by other patients.

N.B.

Blood samples for serum lithium determination should be drawn immediately prior to the next dose

when lithium concentrations are relatively stable (i.e., 8-12 hours after the previous dose). Total

reliance must not be placed on serum levels alone. Accurate patient evaluation requires both clinical and

laboratory analysis.

HOW SUPPLIED

Lithium Carbonate Capsules USP

150 mg opaque buff/opaque buff colored capsules (size 4)

(Identified A 101)

NDC 46708-303-30: Bottles of 30 capsules.

NDC 46708-303-31: Bottles of 100 capsules.

NDC 46708-303-71: Bottles of 500 capsules.

NDC 46708-303-91: Bottles of 1000 capsules.

300 mg opaque light pink/opaque light pink colored capsules (size 2)

(Identified A 102)

NDC 46708-304-30: Bottles of 30 capsules.

NDC 46708-304-31: Bottles of 100 capsules.

NDC 46708-304-71: Bottles of 500 capsules.

NDC 46708-304-91: Bottles of 1000 capsules.

600 mg opaque pink/opaque buff colored capsules (size 0)

(Identified A 103)

NDC 46708-305-30: Bottles of 30 capsules.

NDC 46708-305-31: Bottles of 100 capsules.

NDC 46708-305-71: Bottles of 500 capsules.

Store and Dispense:

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room

Temperature]. Protect from moisture. Dispense in a tight container as defined in the USP/NF.

Manufactured by:

Alembic Pharmaceuticals Limited (Formulation Division),

Village Panelav, P. O. Tajpura, Near Baska,

Taluka-Halol, Panchmahal, Gujarat, India.

Revised: 11/2011

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 150 mg

Lithium Carbonate Capsules USP 150 mg (30 Capsules in 1 Bottle)

Each hard gelatin capsule contains: Lithium Carbonate USP 150 mg

46708-303-30

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 300 mg

Lithium Carbonate Capsules USP 300 mg (30 Capsules in 1 Bottle)

Each hard gelatin capsule contains: Lithium Carbonate USP 300 mg

46708-304-30

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 600 mg

Lithium Carbonate Capsules USP 600 mg (30 Capsules in 1 Bottle)

Each hard gelatin capsule contains: Lithium Carbonate USP 600 mg

46708-305-30

LITHIUM CARBONATE

lithium carbonate capsule

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:46 70 8 -30 3

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LITHIUM CARBO NATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8 H8 Z5UER6 6 )

LITHIUM CARBONATE

150 mg

Inactive Ingredients

Ingredient Name

Stre ng th

TALC (UNII: 7SEV7J4R1U)

GELATIN (UNII: 2G8 6 QN327L)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

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

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

Product Characteristics

Color

YELLOW (Opaque Buff)

S core

no sco re

S hap e

CAPSULE (CAPSULE)

S iz e

14mm

Flavor

Imprint Code

A;10 1

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:46 70 8 -30 3-30

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

12/27/20 16

2

NDC:46 70 8 -30 3-31

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

12/27/20 16

3

NDC:46 70 8 -30 3-71

50 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

12/27/20 16

4

NDC:46 70 8 -30 3-9 1

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

12/27/20 16

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 79 159

12/27/20 16

LITHIUM CARBONATE

lithium carbonate capsule

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:46 70 8 -30 4

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LITHIUM CARBO NATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8 H8 Z5UER6 6 )

LITHIUM CARBONATE

30 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

TALC (UNII: 7SEV7J4R1U)

GELATIN (UNII: 2G8 6 QN327L)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

Product Characteristics

Color

PINK (Opaque Light Pink)

S core

no sco re

S hap e

CAPSULE (CAPSULE)

S iz e

18 mm

Flavor

Imprint Code

A;10 2

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:46 70 8 -30 4-30

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

12/27/20 16

2

NDC:46 70 8 -30 4-31

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

12/27/20 16

3

NDC:46 70 8 -30 4-71

50 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

12/27/20 16

4

NDC:46 70 8 -30 4-9 1

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

12/27/20 16

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 79 159

12/27/20 16

LITHIUM CARBONATE

lithium carbonate capsule

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:46 70 8 -30 5

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LITHIUM CARBO NATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8 H8 Z5UER6 6 )

LITHIUM CARBONATE

6 0 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

TALC (UNII: 7SEV7J4R1U)

GELATIN (UNII: 2G8 6 QN327L)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

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

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

Product Characteristics

Color

PINK (Opaque Pink) , YELLOW (Opaque Buff)

S core

no sco re

S hap e

CAPSULE (CAPSULE)

S iz e

23mm

Flavor

Imprint Code

A;10 3

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:46 70 8 -30 5-30

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

12/27/20 16

2

NDC:46 70 8 -30 5-31

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

12/27/20 16

3

NDC:46 70 8 -30 5-71

50 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

12/27/20 16

Marketing Information

Alembic Pharmaceuticals Limited

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 79 159

12/27/20 16

Labeler -

Alembic Pharmaceuticals Limited (650574663)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Alembic Pharmaceuticals Limited

6 50 5746 71

MANUFACTURE(46 70 8 -30 3, 46 70 8 -30 4, 46 70 8 -30 5)

Revised: 9/2019

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