NDC 61919-214

TEMAZEPAM

Temazepam

TEMAZEPAM is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Temazepam.

Product ID61919-214_3fc5636e-2a4c-3bff-e054-00144ff8d46c
NDC61919-214
Product TypeHuman Prescription Drug
Proprietary NameTEMAZEPAM
Generic NameTemazepam
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2014-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA071638
Labeler NameDIRECT RX
Substance NameTEMAZEPAM
Active Ingredient Strength15 mg/1
Pharm ClassesBenzodiazepine [EPC],Benzodiazepines [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-214-30

30 CAPSULE in 1 BOTTLE (61919-214-30)
Marketing Start Date2015-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-214-30 [61919021430]

TEMAZEPAM CAPSULE
Marketing CategoryANDA
Application NumberANDA071638
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-01

Drug Details

Active Ingredients

IngredientStrength
TEMAZEPAM15 mg/1

OpenFDA Data

SPL SET ID:74f261c5-a960-44ef-be4c-4dcefd881c3f
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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.