NDC 67544-117

Oxazepam

Oxazepam

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

Product ID67544-117_166ba137-98a4-4072-90e1-ab7b6248a351
NDC67544-117
Product TypeHuman Prescription Drug
Proprietary NameOxazepam
Generic NameOxazepam
Dosage FormCapsule, Gelatin Coated
Route of AdministrationORAL
Marketing Start Date2007-01-02
Marketing CategoryANDA / ANDA
Application NumberANDA072251
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameOXAZEPAM
Active Ingredient Strength10 mg/1
Pharm ClassesBenzodiazepine [EPC],Benzodiazepines [CS]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 67544-117-30

30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (67544-117-30)
Marketing Start Date2007-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67544-117-60 [67544011760]

Oxazepam CAPSULE, GELATIN COATED
Marketing CategoryANDA
Application NumberANDA072251
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-01-22

NDC 67544-117-70 [67544011770]

Oxazepam CAPSULE, GELATIN COATED
Marketing CategoryANDA
Application NumberANDA072251
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-02-27

NDC 67544-117-30 [67544011730]

Oxazepam CAPSULE, GELATIN COATED
Marketing CategoryANDA
Application NumberANDA072251
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-02-01

NDC 67544-117-53 [67544011753]

Oxazepam CAPSULE, GELATIN COATED
Marketing CategoryANDA
Application NumberANDA072251
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-01-18

Drug Details

Active Ingredients

IngredientStrength
OXAZEPAM10 mg/1

OpenFDA Data

SPL SET ID:3bccbfa9-fdcf-44c3-86f5-028ca92223ca
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198057
  • 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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