FDA Product

Lithium Carbonate

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Lithium Carbonate

FDA Product Code

46708-304

Regulatory Information

NDC Product Code

46708-304

Application Number

ANDA079159

Marketing Category

C73584

Effective Date

January 30, 2023

Territorial Authority

USA

FDA Title

Lithium Carbonate Capsules USP Rx Only

Labeling Type

Human Prescription Drug Label

Version Number

3

Company Information

ManufacturerAlembic Pharmaceuticals Limited

DUNS Number

650574663

Active Ingredients

LITHIUM CARBONATE

Quantity: 300 mg in 1 1

Code: 2BMD2GNA4V

Class Code: ACTIB

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

Active Moieties

LITHIUM CATION

Code: 8H8Z5UER66

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