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Lithium Carbonate

Lithium Carbonate Capsules USP150 mg, 300 mg and 600 mg

Approved
Approval ID

18dc0a0c-8cee-4d20-9350-895d8de85147

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 6, 2010

Manufacturers
FDA

State of Florida DOH Central Pharmacy

DUNS: 829348114

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Lithium Carbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53808-0643
Application NumberANDA076795
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lithium Carbonate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 6, 2010
FDA Product Classification

INGREDIENTS (17)

D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
LITHIUM CARBONATEActive
Quantity: 300 mg in 1 1
Code: 2BMD2GNA4V
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT

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Lithium Carbonate - FDA Drug Approval Details