COMBIVIR
These highlights do not include all the information needed to use COMBIVIR safely and effectively. See full prescribing information for COMBIVIR. COMBIVIR (lamivudine and zidovudine) Tablets 150 mg/300 mgInitial U.S. Approval: 1997
Approved
Approval ID
d8540843-055c-47fb-9cff-81e64b1d41c3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 24, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-846
Application NumberNDA020857
Product Classification
M
Marketing Category
C73594
G
Generic Name
lamivudine and zidovudine
Product Specifications
Route of AdministrationORAL
Effective DateMay 12, 2009
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
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT