NDC 0597-0047

Viramune

Nevirapine

Viramune is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals Inc.. The primary component is Nevirapine.

Product ID0597-0047_479960ea-77f0-4c8d-b5c8-0dae669fc194
NDC0597-0047
Product TypeHuman Prescription Drug
Proprietary NameViramune
Generic NameNevirapine
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2001-10-01
Marketing CategoryNDA / NDA
Application NumberNDA020933
Labeler NameBoehringer Ingelheim Pharmaceuticals Inc.
Substance NameNEVIRAPINE
Active Ingredient Strength50 mg/5mL
Pharm ClassesHuman Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [EXT],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0597-0047-24

1 BOTTLE, PLASTIC in 1 CARTON (0597-0047-24) > 240 mL in 1 BOTTLE, PLASTIC
Marketing Start Date2001-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0597-0047-24 [00597004724]

Viramune SUSPENSION
Marketing CategoryNDA
Application NumberNDA020933
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2001-10-01

Drug Details

Active Ingredients

IngredientStrength
NEVIRAPINE50 mg/5mL

OpenFDA Data

SPL SET ID:5ec05500-6333-4bd0-ac83-464fad0d5162
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311943
  • 211327
  • 213405
  • 199422
    • UPC Code
  • 0305970046608

    • Pharmacological Class

    • Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
    • Non-Nucleoside Analog [EXT]
    • Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]
    • Cytochrome P450 3A Inducers [MoA]
    • Cytochrome P450 2B6 Inducers [MoA]

    NDC Crossover Matching brand name "Viramune" or generic name "Nevirapine"

    NDCBrand NameGeneric Name
    0597-0046Viramunenevirapine
    0597-0047Viramunenevirapine
    0597-0123Viramunenevirapine
    53808-0808Viramunenevirapine
    0378-4050Nevirapinenevirapine
    0378-4890Nevirapinenevirapine
    0378-6950Nevirapinenevirapine
    0781-5893NevirapineNevirapine
    31722-505NevirapineNevirapine
    33342-004NevirapineNevirapine
    33342-238NEVIRAPINENEVIRAPINE
    42571-131NEVIRAPINENEVIRAPINE
    51991-331NevirapineNEVIRAPINE
    53104-0166nevirapinenevirapine
    53808-0680Nevirapinenevirapine
    53808-1069nevirapinenevirapine
    61442-470NevirapineNevirapine
    64380-709NevirapineNevirapine
    65162-209NevirapineNevirapine
    47781-317Nevirapine Extended Releasenevirapine

    Trademark Results [Viramune]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VIRAMUNE
    VIRAMUNE
    74423308 1905263 Live/Registered
    BOEHRINGER INGELHEIM PHARMACUETICALS, INC.
    1993-08-12
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.