Lamivudine and Zidovudine
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, for oral use Initial U.S. Approval: 1997
Approved
Approval ID
d40292ff-046c-4a04-b801-10768667951a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 11, 2022
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
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 Code65862-036
Application NumberANDA077558
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lamivudine and Zidovudine
Product Specifications
Route of AdministrationORAL
Effective DateMay 11, 2022
FDA Product Classification
INGREDIENTS (10)
LAMIVUDINEActive
Quantity: 150 mg in 1 1
Code: 2T8Q726O95
Classification: ACTIB
ZIDOVUDINEActive
Quantity: 300 mg in 1 1
Code: 4B9XT59T7S
Classification: ACTIB
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT