NDC 0406-9917

RESTORIL

Temazepam

RESTORIL is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Specgx Llc. The primary component is Temazepam.

Product ID0406-9917_6e1d8b85-8e3c-4128-af3a-7218ed3c1899
NDC0406-9917
Product TypeHuman Prescription Drug
Proprietary NameRESTORIL
Generic NameTemazepam
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date1981-02-27
Marketing CategoryNDA / NDA
Application NumberNDA018163
Labeler NameSpecGx LLC
Substance NameTEMAZEPAM
Active Ingredient Strength30 mg/1
Pharm ClassesBenzodiazepine [EPC],Benzodiazepines [CS]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0406-9917-01

100 CAPSULE in 1 BOTTLE (0406-9917-01)
Marketing Start Date1981-02-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0406-9917-01 [00406991701]

RESTORIL CAPSULE
Marketing CategoryNDA
Application NumberNDA018163
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1981-02-27

NDC 0406-9917-05 [00406991705]

RESTORIL CAPSULE
Marketing CategoryNDA
Application NumberNDA018163
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1981-02-27
Marketing End Date2009-10-30

Drug Details

Active Ingredients

IngredientStrength
TEMAZEPAM30 mg/1

OpenFDA Data

SPL SET ID:bc56f7fd-1aaf-48ff-8aa7-d467e59e1015
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 208465
  • 198242
  • 198243
  • 208464
  • 198241
  • 208463
  • 539384
  • 485489
  • UPC Code
  • 0304069917010
  • 0304069916013
  • 0304069915016
  • 0304069914033
  • Pharmacological Class

    • Benzodiazepine [EPC]
    • Benzodiazepines [CS]

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

    NDCBrand NameGeneric Name
    0406-9914RESTORILtemazepam
    0406-9915RESTORILtemazepam
    0406-9916RESTORILtemazepam
    0406-9917RESTORILtemazepam
    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

    Trademark Results [RESTORIL]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    RESTORIL
    RESTORIL
    73118455 1076802 Dead/Cancelled
    SANDOZ, INC.
    1977-03-09
    RESTORIL
    RESTORIL
    73058683 1038108 Live/Registered
    SANDOZ, INC.
    1975-07-25

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