NDC 0781-5893

Nevirapine

Nevirapine

Nevirapine is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Nevirapine.

Product ID0781-5893_71d555c0-49ff-4c9b-a3ee-dbbe89efbf5f
NDC0781-5893
Product TypeHuman Prescription Drug
Proprietary NameNevirapine
Generic NameNevirapine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2014-04-15
Marketing CategoryANDA / ANDA
Application NumberANDA203411
Labeler NameSandoz Inc
Substance NameNEVIRAPINE
Active Ingredient Strength400 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 0781-5893-05

500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5893-05)
Marketing Start Date2014-04-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-5893-31 [00781589331]

Nevirapine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203411
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-04-15

NDC 0781-5893-05 [00781589305]

Nevirapine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203411
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-04-15

Drug Details

Active Ingredients

IngredientStrength
NEVIRAPINE400 mg/1

OpenFDA Data

SPL SET ID:24fd285a-bec3-41b5-9026-b263da83c54f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1095712
  • 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 "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

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