NDC 0378-4050

Nevirapine

Nevirapine

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

Product ID0378-4050_7bd83a74-71cc-472e-bfac-2f721b866905
NDC0378-4050
Product TypeHuman Prescription Drug
Proprietary NameNevirapine
Generic NameNevirapine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-05-22
Marketing CategoryANDA / ANDA
Application NumberANDA202523
Labeler NameMylan 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 0378-4050-91

60 TABLET in 1 BOTTLE, PLASTIC (0378-4050-91)
Marketing Start Date2012-05-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-4050-80 [00378405080]

Nevirapine TABLET
Marketing CategoryANDA
Application NumberANDA202523
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-05-22
Marketing End Date2016-02-18

NDC 0378-4050-91 [00378405091]

Nevirapine TABLET
Marketing CategoryANDA
Application NumberANDA202523
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-05-22

NDC 0378-4050-05 [00378405005]

Nevirapine TABLET
Marketing CategoryANDA
Application NumberANDA202523
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-05-22
Marketing End Date2016-02-18

Drug Details

Active Ingredients

IngredientStrength
NEVIRAPINE200 mg/1

OpenFDA Data

SPL SET ID:c6e93829-7024-48f6-8023-da6ff27dfc0a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199422
    • UPC Code
  • 0303784050910

    • 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]
    • 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 "Nevirapine" or generic name "Nevirapine"

    NDCBrand NameGeneric Name
    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
    69097-403NEVIRAPINENEVIRAPINE
    69097-233nevirapinenevirapine
    65862-057NevirapineNevirapine
    65862-027NevirapineNevirapine
    65862-932NEVIRAPINENEVIRAPINE
    65862-933NEVIRAPINENEVIRAPINE
    47781-317Nevirapine Extended Releasenevirapine
    0597-0046Viramunenevirapine
    0597-0047Viramunenevirapine
    0597-0123Viramunenevirapine
    53808-0808Viramunenevirapine
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.