Viramune
These highlights do not include all the information needed to use VIRAMUNE safely and effectively. See full prescribing information for VIRAMUNE. Viramune® (nevirapine) tablets 200 mg Viramune® (nevirapine) oral suspension 50 mg/5 mL Initial U.S. Approval: 1996
Approved
Approval ID
46fb9dbc-5345-48a4-a0ec-75039622c76c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 21, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
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 Code53808-0808
Application NumberNDA020636
Product Classification
M
Marketing Category
C73594
G
Generic Name
nevirapine
Product Specifications
Route of AdministrationORAL
Effective DateMay 21, 2010
FDA Product Classification
INGREDIENTS (7)
NEVIRAPINEActive
Quantity: 200 mg in 1 1
Code: 99DK7FVK1H
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT