NDC 0597-0046

Viramune

Nevirapine

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

Product ID0597-0046_625370f8-2aa2-b0fb-b095-35c91cb291da
NDC0597-0046
Product TypeHuman Prescription Drug
Proprietary NameViramune
Generic NameNevirapine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2001-08-01
Marketing CategoryNDA / NDA
Application NumberNDA020636
Labeler NameBoehringer Ingelheim Pharmaceuticals Inc.
Substance NameNEVIRAPINE
Active Ingredient Strength200 mg/1
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 Through2020-12-31

Packaging

NDC 0597-0046-60

60 TABLET in 1 BOTTLE (0597-0046-60)
Marketing Start Date2001-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0597-0046-60 [00597004660]

Viramune TABLET
Marketing CategoryNDA
Application NumberNDA020636
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-08-01

NDC 0597-0046-41 [00597004641]

Viramune TABLET
Marketing CategoryNDA
Application NumberNDA020636
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-10-21
Marketing End Date2017-04-11

NDC 0597-0046-46 [00597004646]

Viramune TABLET
Marketing CategoryNDA
Application NumberNDA020636
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-02-11
Marketing End Date2017-04-11

NDC 0597-0046-61 [00597004661]

Viramune TABLET
Marketing CategoryNDA
Application NumberNDA020636
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-02-04
Marketing End Date2010-04-02

Drug Details

Active Ingredients

IngredientStrength
NEVIRAPINE200 mg/1

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
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