Viramune
These highlights do not include all the information needed to use VIRAMUNE XR safely and effectively. See full prescribing information for VIRAMUNE XR. Viramune XR® (nevirapine) Extended-Release Tablets, for oral useInitial U.S. Approval: 1996
Approved
Approval ID
09f08fe4-69ee-4f03-8663-62aa76b3ad97
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 6, 2013
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-6370
Application NumberNDA201152
Product Classification
M
Marketing Category
C73594
G
Generic Name
nevirapine
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 6, 2013
FDA Product Classification
INGREDIENTS (1)
NEVIRAPINEActive
Quantity: 400 mg in 1 1
Code: 99DK7FVK1H
Classification: ACTIB