Lithium Carbonate
Lithium Carbonate Extended-release Tablets, USP 300 mg
Approved
Approval ID
c612b6c5-eeb9-4fdd-8c85-bb3d2147cd1e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 28, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 080189610
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 Code0054-0021
Application NumberANDA076832
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lithium Carbonate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 19, 2018
FDA Product Classification
INGREDIENTS (13)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LITHIUM CARBONATEActive
Quantity: 300 mg in 1 1
Code: 2BMD2GNA4V
Classification: ACTIB
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT