Zidovudine
These highlights do not include all the information needed to use ZIDOVUDINE . See full prescribing information for ZIDOVUDINE. Initial U.S. Approval: 1987
Approved
Approval ID
1b34c6ec-ac27-455e-976e-d22cf9d81950
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 26, 2011
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.
ZIDOVUDINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-369
Application NumberANDA077267
Product Classification
M
Marketing Category
C73584
G
Generic Name
ZIDOVUDINE
Product Specifications
Route of AdministrationORAL
Effective DateApril 13, 2010
FDA Product Classification
INGREDIENTS (7)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ZIDOVUDINEActive
Quantity: 300 mg in 1 1
Code: 4B9XT59T7S
Classification: ACTIB