NDC 67544-294

Oxazepam

Oxazepam

Oxazepam is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Oxazepam.

Product ID67544-294_d3b80cc9-6730-42f7-8800-b6a52b432f9b
NDC67544-294
Product TypeHuman Prescription Drug
Proprietary NameOxazepam
Generic NameOxazepam
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date1988-04-19
Marketing End Date2019-08-31
Marketing CategoryANDA / ANDA
Application NumberANDA071756
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameOXAZEPAM
Active Ingredient Strength15 mg/1
Pharm ClassesBenzodiazepine [EPC],Benzodiazepines [CS]
DEA ScheduleCIV
NDC Exclude FlagN

Packaging

NDC 67544-294-53

60 CAPSULE in 1 BOTTLE (67544-294-53)
Marketing Start Date2014-11-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67544-294-30 [67544029430]

Oxazepam CAPSULE
Marketing CategoryANDA
Application NumberANDA071756
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-11-05
Marketing End Date2019-08-31

NDC 67544-294-53 [67544029453]

Oxazepam CAPSULE
Marketing CategoryANDA
Application NumberANDA071756
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-11-06
Marketing End Date2019-08-31

NDC 67544-294-60 [67544029460]

Oxazepam CAPSULE
Marketing CategoryANDA
Application NumberANDA071756
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-10-29
Marketing End Date2019-08-31

Drug Details

Active Ingredients

IngredientStrength
OXAZEPAM15 mg/1

OpenFDA Data

SPL SET ID:1301ca49-2f8b-4d97-85be-ebfc303a33c4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312134

    • Pharmacological Class

    • Benzodiazepine [EPC]
    • Benzodiazepines [CS]

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

    NDCBrand NameGeneric Name
    0228-2067OxazepamOxazepam
    0228-2069OxazepamOxazepam
    0228-2073OxazepamOxazepam
    0781-2809OxazepamOxazepam
    0781-2810OxazepamOxazepam
    0781-2811OxazepamOxazepam
    43353-074OxazepamOxazepam
    43353-965OxazepamOxazepam
    43353-980OxazepamOxazepam
    52817-290OxazepamOxazepam
    52817-291OxazepamOxazepam
    52817-292OxazepamOxazepam
    62584-812OxazepamOxazepam
    62584-813OxazepamOxazepam
    62584-814OxazepamOxazepam
    67544-294OxazepamOxazepam
    67544-117OxazepamOxazepam
    67544-268OxazepamOxazepam
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