Nevirapine
These highlights do not include all the information needed to use NEVIRAPINE TABLETS safely and effectively. See full prescribing information for NEVIRAPINE TABLETS. NEVIRAPINE tablets, USP for oral use. Initial U.S. Approval: 1996
Approved
Approval ID
61409678-d2f6-42cd-b03d-b26b11b39641
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 3, 2022
Manufacturers
FDA
Camber Pharmaceuticals, Inc.
DUNS: 826774775
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 Code31722-505
Application NumberANDA078584
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nevirapine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 3, 2022
FDA Product Classification
INGREDIENTS (8)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
NEVIRAPINEActive
Quantity: 200 mg in 1 1
Code: 99DK7FVK1H
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT