NDC 69097-233

nevirapine

Nevirapine

nevirapine is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Cipla Usa Inc.. The primary component is Nevirapine Hemihydrate.

Product ID69097-233_d8c3e274-100e-4526-84a2-ef541b415d4e
NDC69097-233
Product TypeHuman Prescription Drug
Proprietary Namenevirapine
Generic NameNevirapine
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2017-08-03
Marketing CategoryANDA / ANDA
Application NumberANDA207684
Labeler NameCipla USA Inc.
Substance NameNEVIRAPINE HEMIHYDRATE
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 Through2019-12-31

Packaging

NDC 69097-233-44

100 mL in 1 BOTTLE (69097-233-44)
Marketing Start Date2017-08-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69097-233-44 [69097023344]

nevirapine SUSPENSION
Marketing CategoryANDA
Application NumberANDA207684
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-03
Inactivation Date2020-01-31

NDC 69097-233-46 [69097023346]

nevirapine SUSPENSION
Marketing CategoryANDA
Application NumberANDA207684
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-03
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NEVIRAPINE HEMIHYDRATE50 mg/5mL

OpenFDA Data

SPL SET ID:d1e92221-5e02-4ed9-b53e-d83bbbd07944
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311943

    • 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.