NDC 68788-6986

Temazepam

Temazepam

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

Product ID68788-6986_0657eb0f-4eb0-4814-91a0-9ba1b22a8a09
NDC68788-6986
Product TypeHuman Prescription Drug
Proprietary NameTemazepam
Generic NameTemazepam
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2017-07-05
Marketing CategoryANDA / ANDA
Application NumberANDA071620
Labeler NamePreferred Pharmaceuticals Inc.
Substance NameTEMAZEPAM
Active Ingredient Strength30 mg/1
Pharm ClassesBenzodiazepine [EPC],Benzodiazepines [CS]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68788-6986-1

100 CAPSULE in 1 BOTTLE (68788-6986-1)
Marketing Start Date2017-07-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-6986-1 [68788698601]

Temazepam CAPSULE
Marketing CategoryANDA
Application NumberANDA071620
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-05

NDC 68788-6986-6 [68788698606]

Temazepam CAPSULE
Marketing CategoryANDA
Application NumberANDA071620
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-05

NDC 68788-6986-8 [68788698608]

Temazepam CAPSULE
Marketing CategoryANDA
Application NumberANDA071620
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-05

NDC 68788-6986-9 [68788698609]

Temazepam CAPSULE
Marketing CategoryANDA
Application NumberANDA071620
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-05

NDC 68788-6986-3 [68788698603]

Temazepam CAPSULE
Marketing CategoryANDA
Application NumberANDA071620
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-05

Drug Details

Active Ingredients

IngredientStrength
TEMAZEPAM30 mg/1

OpenFDA Data

SPL SET ID:6beccd63-d4f7-4ffd-89ef-bc63707d6c78
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198242
  • Pharmacological Class

    • Benzodiazepine [EPC]
    • Benzodiazepines [CS]
    • 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.