LAMIVUDINE and ZIDOVUDINE
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LAMIVUDINE and ZIDOVUDINE TABLETS safely and effectively. See full prescribing information for LAMIVUDINE and ZIDOVUDINE TABLETS. LAMIVUDINE and ZIDOVUDINE tablets USP, for oral use Initial U.S. Approval: 1997
Approved
Approval ID
6d095b8c-5dcf-4501-e053-2a91aa0a64a3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 14, 2022
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LAMIVUDINE and ZIDOVUDINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68071-4450
Application NumberANDA079124
Product Classification
M
Marketing Category
C73584
G
Generic Name
LAMIVUDINE and ZIDOVUDINE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 14, 2022
FDA Product Classification
INGREDIENTS (10)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LAMIVUDINEActive
Quantity: 150 mg in 1 1
Code: 2T8Q726O95
Classification: ACTIB
ZIDOVUDINEActive
Quantity: 300 mg in 1 1
Code: 4B9XT59T7S
Classification: ACTIB