NDC 63629-1619

temazepam

Temazepam

temazepam is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Temazepam.

Product ID63629-1619_ac08a51c-6c54-40da-9626-a4c82f337a3a
NDC63629-1619
Product TypeHuman Prescription Drug
Proprietary Nametemazepam
Generic NameTemazepam
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date1987-04-21
Marketing CategoryANDA / ANDA
Application NumberANDA071456
Labeler NameBryant Ranch Prepack
Substance NameTEMAZEPAM
Active Ingredient Strength15 mg/1
Pharm ClassesBenzodiazepine [EPC], Benzodiazepines [CS]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63629-1619-1

20 CAPSULE in 1 BOTTLE (63629-1619-1)
Marketing Start Date2010-06-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-1619-3 [63629161903]

temazepam CAPSULE
Marketing CategoryANDA
Application NumberANDA071456
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-03-04

NDC 63629-1619-7 [63629161907]

temazepam CAPSULE
Marketing CategoryANDA
Application NumberANDA071456
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-04

NDC 63629-1619-5 [63629161905]

temazepam CAPSULE
Marketing CategoryANDA
Application NumberANDA071456
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-04

NDC 63629-1619-2 [63629161902]

temazepam CAPSULE
Marketing CategoryANDA
Application NumberANDA071456
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-03-04

NDC 63629-1619-6 [63629161906]

temazepam CAPSULE
Marketing CategoryANDA
Application NumberANDA071456
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-07-28

NDC 63629-1619-1 [63629161901]

temazepam CAPSULE
Marketing CategoryANDA
Application NumberANDA071456
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-03-04

NDC 63629-1619-4 [63629161904]

temazepam CAPSULE
Marketing CategoryANDA
Application NumberANDA071456
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-03-04

Drug Details

Active Ingredients

IngredientStrength
TEMAZEPAM15 mg/1

OpenFDA Data

SPL SET ID:1c08d30d-7c27-a09a-5240-7050771d5cc7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198241

    • Pharmacological Class

    • Benzodiazepine [EPC]
    • Benzodiazepines [CS]

    NDC Crossover Matching brand name "temazepam" or generic name "Temazepam"

    NDCBrand NameGeneric Name
    0228-2076TemazepamTemazepam
    0228-2077TemazepamTemazepam
    0378-3110Temazepamtemazepam
    0378-3120Temazepamtemazepam
    0378-4010Temazepamtemazepam
    0378-5050Temazepamtemazepam
    0406-9959TEMAZEPAMtemazepam
    0406-9960TEMAZEPAMtemazepam
    0406-9961TEMAZEPAMtemazepam
    0406-9962TEMAZEPAMtemazepam
    0440-8474temazepamtemazepam
    0440-8475temazepamtemazepam
    0440-8476temazepamtemazepam
    0440-8477temazepamtemazepam
    0615-7808TemazepamTemazepam
    0615-7809TemazepamTemazepam
    67877-148temazepamtemazepam
    67877-146temazepamtemazepam
    67877-149temazepamtemazepam
    67877-147temazepamtemazepam
    68071-4083TemazepamTemazepam
    68071-4100TemazepamTemazepam
    68084-549TEMAZEPAMTEMAZEPAM
    68788-6986TemazepamTemazepam
    68788-7163TemazepamTemazepam
    68788-6904TemazepamTemazepam
    70518-0647temazepamtemazepam
    70518-1944TemazepamTemazepam
    70518-1754TemazepamTemazepam
    71335-0315TemazepamTemazepam
    71335-0527TemazepamTemazepam
    71610-004TEMAZEPAMTEMAZEPAM
    71610-089temazepamtemazepam
    71610-086temazepamtemazepam
    71610-101temazepamtemazepam
    0781-2201TemazepamTemazepam
    0781-2202TemazepamTemazepam
    0904-6436TemazepamTemazepam
    21695-282temazepamtemazepam
    21695-283temazepamtemazepam
    33261-102TemazepamTemazepam
    33261-101TemazepamTemazepam
    33358-332TemazepamTemazepam
    35356-664temazepamtemazepam
    35356-663temazepamtemazepam
    35356-821temazepamtemazepam
    40032-121TemazepamTemazepam
    40032-123TemazepamTemazepam
    40032-122TemazepamTemazepam
    40032-120TemazepamTemazepam
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