Abacavir and Lamivudine
These highlights do not include all the information needed to use ABACAVIR AND LAMIVUDINE TABLETS safely and effectively. See full prescribing information for ABACAVIR AND LAMIVUDINE TABLETS. ABACAVIR AND LAMIVUDINE TABLETS, for oral use Initial U.S. Approval: 2004
Approved
Approval ID
d36624c8-d773-4f99-81fc-433fae17feb3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 3, 2025
Manufacturers
FDA
Macleods Pharmaceuticals Limited
DUNS: 862128535
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Abacavir and Lamivudine
PRODUCT DETAILS
NDC Product Code33342-440
Application NumberANDA212663
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 3, 2025
Generic NameAbacavir and Lamivudine
INGREDIENTS (13)
ABACAVIR SULFATEActive
Quantity: 600 mg in 1 1
Code: J220T4J9Q2
Classification: ACTIM
LAMIVUDINEActive
Quantity: 300 mg in 1 1
Code: 2T8Q726O95
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT