LITHIUM CARBONATE
Lithium Carbonate Capsules USP Rx Only
Approved
Approval ID
95fad5f7-aac1-4600-a694-4f89ff53bfa9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 23, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
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 Code54868-3632
Application NumberANDA090702
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lithium Carbonate
Product Specifications
Route of AdministrationORAL
Effective DateApril 5, 2011
FDA Product Classification
INGREDIENTS (14)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
LITHIUM CARBONATEActive
Quantity: 150 mg in 1 1
Code: 2BMD2GNA4V
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
Lithium Carbonate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-1335
Application NumberANDA090702
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lithium Carbonate
Product Specifications
Route of AdministrationORAL
Effective DateApril 5, 2011
FDA Product Classification
INGREDIENTS (14)
LITHIUM CARBONATEActive
Quantity: 300 mg in 1 1
Code: 2BMD2GNA4V
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT