NDC 43353-980

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 ID43353-980_d630cdd9-fe25-4ea6-8a1f-0100bb6e6cb5
NDC43353-980
Product TypeHuman Prescription Drug
Proprietary NameOxazepam
Generic NameOxazepam
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date1988-04-19
Marketing CategoryANDA / ANDA
Application NumberANDA071814
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameOXAZEPAM
Active Ingredient Strength30 mg/1
Pharm ClassesBenzodiazepine [EPC],Benzodiazepines [CS]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43353-980-30

30 CAPSULE in 1 BOTTLE (43353-980-30)
Marketing Start Date2014-11-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-980-30 [43353098030]

Oxazepam CAPSULE
Marketing CategoryANDA
Application NumberANDA071814
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-11-06

Drug Details

Active Ingredients

IngredientStrength
OXAZEPAM30 mg/1

OpenFDA Data

SPL SET ID:1382470a-7eec-4e7c-aa86-15254fb57a5a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198057
  • 198059
  • Pharmacological Class

    • Benzodiazepine [EPC]
    • Benzodiazepines [CS]
    • 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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