Nevirapine
These highlights do not include all the information needed to use Nevirapine safely and effectively. See full prescribing information for Nevirapine. Nevirapine Tablets, USP 200 mg for oral use Initial U.S. Approval: 1996
Approved
Approval ID
4f065674-4719-4c79-ba0d-549040d77f17
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 20, 2012
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 123797875
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 Code65162-209
Application NumberANDA078195
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nevirapine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 20, 2012
FDA Product Classification
INGREDIENTS (8)
NEVIRAPINEActive
Quantity: 200 mg in 1 1
Code: 99DK7FVK1H
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT