NDC 0378-3110

Temazepam

Temazepam

Temazepam is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Temazepam.

Product ID0378-3110_57e251a0-cc54-4ae9-818d-a2f168e3fb13
NDC0378-3110
Product TypeHuman Prescription Drug
Proprietary NameTemazepam
Generic NameTemazepam
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2010-05-18
Marketing CategoryANDA / ANDA
Application NumberANDA070920
Labeler NameMylan Pharmaceuticals Inc.
Substance NameTEMAZEPAM
Active Ingredient Strength8 mg/1
Pharm ClassesBenzodiazepine [EPC],Benzodiazepines [CS]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-3110-01

100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01)
Marketing Start Date2010-05-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-3110-01 [00378311001]

Temazepam CAPSULE
Marketing CategoryANDA
Application NumberANDA070920
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-05-18

NDC 0378-3110-93 [00378311093]

Temazepam CAPSULE
Marketing CategoryANDA
Application NumberANDA070920
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-05-18
Marketing End Date2015-08-31

NDC 0378-3110-05 [00378311005]

Temazepam CAPSULE
Marketing CategoryANDA
Application NumberANDA070920
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-05-18
Marketing End Date2015-08-31

Drug Details

Active Ingredients

IngredientStrength
TEMAZEPAM7.5 mg/1

OpenFDA Data

SPL SET ID:a5416154-8490-4e84-bb6f-4ff0cc605214
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198242
  • 198243
  • 198241
  • 485489

    • 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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