NDC 53808-0808

Viramune

Nevirapine

Viramune is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by State Of Florida Doh Central Pharmacy. The primary component is Nevirapine.

Product ID53808-0808_46b0051f-5908-4d1d-967b-4085a0909b4a
NDC53808-0808
Product TypeHuman Prescription Drug
Proprietary NameViramune
Generic NameNevirapine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-07-01
Marketing CategoryNDA / NDA
Application NumberNDA020636
Labeler NameState of Florida DOH Central Pharmacy
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 FlagE
Listing Certified Through2017-12-31

Packaging

NDC 53808-0808-1

30 TABLET in 1 BLISTER PACK (53808-0808-1)
Marketing Start Date2009-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53808-0808-1 [53808080801]

Viramune TABLET
Marketing CategoryNDA
Application NumberNDA020636
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-07-01
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
NEVIRAPINE200 mg/1

OpenFDA Data

SPL SET ID:46fb9dbc-5345-48a4-a0ec-75039622c76c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 211327
  • 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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