Lamivudine and Zidovudine
These highlights do not include all the information needed to use lamivudine and zidovudine tablets USP safely and effectively. See full prescribing information for lamivudine and zidovudine tablets USP.LAMIVUDINE and ZIDOVUDINE tablets, USP 150 mg/300 mg for oral use Initial U.S. Approval: 1997
Approved
Approval ID
d346d08d-ebb5-4500-923f-fe111f304876
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 4, 2012
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 Code21695-996
Application NumberANDA079081
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lamivudine and Zidovudine
Product Specifications
Route of AdministrationORAL
Effective DateApril 26, 2010
FDA Product Classification
INGREDIENTS (10)
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LAMIVUDINEActive
Quantity: 150 mg in 1 1
Code: 2T8Q726O95
Classification: ACTIB
ZIDOVUDINEActive
Quantity: 300 mg in 1 1
Code: 4B9XT59T7S
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT