NEVIRAPINE
These highlights do not include all the information needed to use NEVIRAPINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for NEVIRAPINE EXTENDED-RELEASE TABLETS. NEVIRAPINE extended-release tablets, for oral use Initial U.S. Approval: 1996
Approved
Approval ID
2620b114-f53f-44f1-8708-697e86343090
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 13, 2023
Manufacturers
FDA
Macleods Pharmaceuticals Limited
DUNS: 862128535
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NEVIRAPINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33342-238
Application NumberANDA206879
Product Classification
M
Marketing Category
C73584
G
Generic Name
NEVIRAPINE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 13, 2023
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
NEVIRAPINEActive
Quantity: 400 mg in 1 1
Code: 99DK7FVK1H
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT