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, 200 mg, for oral use Initial U.S. Approval: 1996
Approved
Approval ID
4d056e75-6122-4733-96cc-b21c7c944192
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 27, 2018
Manufacturers
FDA
Cipla Ltd.
DUNS: 650138746
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 Code53104-0166
Application NumberANDA077956
Product Classification
M
Marketing Category
C73584
G
Generic Name
nevirapine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 27, 2018
FDA Product Classification
INGREDIENTS (6)
NEVIRAPINEActive
Quantity: 200 mg in 1 1
Code: 99DK7FVK1H
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT