NDC 0054-4858

Triazolam

Triazolam

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

Product ID0054-4858_0cb92a63-1545-41a9-a071-3d134483bb20
NDC0054-4858
Product TypeHuman Prescription Drug
Proprietary NameTriazolam
Generic NameTriazolam
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-10-29
Marketing CategoryANDA / ANDA
Application NumberANDA074224
Labeler NameHikma Pharmaceuticals USA Inc.
Substance NameTRIAZOLAM
Active Ingredient Strength0 mg/1
Pharm ClassesBenzodiazepine [EPC],Benzodiazepines [CS]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0054-4858-25

100 TABLET in 1 BOTTLE (0054-4858-25)
Marketing Start Date2018-10-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0054-4858-51 [00054485851]

Triazolam TABLET
Marketing CategoryANDA
Application NumberANDA074224
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-07-13
Marketing End Date2015-01-07

NDC 0054-4858-06 [00054485806]

Triazolam TABLET
Marketing CategoryANDA
Application NumberANDA074224
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-29
Marketing End Date2009-11-18

NDC 0054-4858-25 [00054485825]

Triazolam TABLET
Marketing CategoryANDA
Application NumberANDA074224
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-29

NDC 0054-4858-29 [00054485829]

Triazolam TABLET
Marketing CategoryANDA
Application NumberANDA074224
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-29
Marketing End Date2009-11-18

Drug Details

Active Ingredients

IngredientStrength
TRIAZOLAM.125 mg/1

OpenFDA Data

SPL SET ID:db564864-17fc-4ba5-a438-a467ef57a0ca
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198318
  • 198317
    • UPC Code
  • 0300544858250
  • 0300544859257

    • Pharmacological Class

    • Benzodiazepine [EPC]
    • Benzodiazepines [CS]

    NDC Crossover Matching brand name "Triazolam" or generic name "Triazolam"

    NDCBrand NameGeneric Name
    0054-4858TriazolamTriazolam
    0054-4859TriazolamTriazolam
    21695-284TriazolamTriazolam
    21695-303TriazolamTriazolam
    43063-996TriazolamTriazolam
    43353-451Triazolamtriazolam
    50090-0522Triazolamtriazolam
    50090-4733TriazolamTriazolam
    50436-3718Triazolamtriazolam
    50742-645TriazolamTriazolam
    50742-646TriazolamTriazolam
    55289-787Triazolamtriazolam
    59762-3717Triazolamtriazolam
    59762-3718Triazolamtriazolam
    67544-725TriazolamTriazolam
    63629-2956TriazolamTriazolam
    0009-0017Halciontriazolam
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.