Zidovudine
These highlights do not include all the information needed to use ZIDOVUDINE TABLETS safely and effectively. See full prescribing information for ZIDOVUDINE TABLETS. ZIDOVUDINE tablets, for oral use Initial U.S. Approval: 1987
Approved
Approval ID
e7c8ddef-005d-4f1c-8c1a-ea84044ab4d4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2024
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.
Zidovudine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65862-024
Application NumberANDA077267
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zidovudine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 25, 2024
FDA Product Classification
INGREDIENTS (8)
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
ZIDOVUDINEActive
Quantity: 300 mg in 1 1
Code: 4B9XT59T7S
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT