EPIVIR
These highlights do not include all the information needed to use EPIVIR safely and effectively. See full prescribing information for EPIVIR.EPIVIR (lamivudine) Tablets and Oral SolutionInitial U.S. Approval: 1995
Approved
Approval ID
166abd26-675e-4832-9d18-0567f2a9d4e4
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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-367
Application NumberNDA020564
Product Classification
M
Marketing Category
C73594
G
Generic Name
lamivudine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2006
FDA Product Classification
INGREDIENTS (8)
LAMIVUDINEActive
Quantity: 150 mg in 1 1
Code: 2T8Q726O95
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT