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 ID: 0406-9917_6e1d8b85-8e3c-4128-af3a-7218ed3c1899
• NDC: 0406-9917
• Product Type: Human Prescription Drug
• Proprietary Name: RESTORIL
• Generic Name: Temazepam
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 1981-02-27
• Marketing Category: NDA / NDA
• Application Number: NDA018163
• Labeler Name: SpecGx LLC
• Substance Name: TEMAZEPAM
• Active Ingredient Strength: 30 mg/1
• Pharm Classes: Benzodiazepine [EPC],Benzodiazepines [CS]
• DEA Schedule: CIV
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0406-9917-01

100 CAPSULE in 1 BOTTLE (0406-9917-01)

• Marketing Start Date: 1981-02-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0406-9917-01 [00406991701]

RESTORIL CAPSULE

• Marketing Category: NDA
• Application Number: NDA018163
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1981-02-27

NDC 0406-9917-05 [00406991705]

RESTORIL CAPSULE

• Marketing Category: NDA
• Application Number: NDA018163
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1981-02-27
• Marketing End Date: 2009-10-30

Drug Details

Active Ingredients

Ingredient	Strength
TEMAZEPAM	30 mg/1

OpenFDA Data

• SPL SET ID: bc56f7fd-1aaf-48ff-8aa7-d467e59e1015
• Manufacturer:
  • SpecGx LLC
• UNII:
  • CHB1QD2QSS
• 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"

NDC	Brand Name	Generic Name
0406-9914	RESTORIL	temazepam
0406-9915	RESTORIL	temazepam
0406-9916	RESTORIL	temazepam
0406-9917	RESTORIL	temazepam
0228-2076	Temazepam	Temazepam
0228-2077	Temazepam	Temazepam
0378-3110	Temazepam	temazepam
0378-3120	Temazepam	temazepam
0378-4010	Temazepam	temazepam
0378-5050	Temazepam	temazepam
0406-9959	TEMAZEPAM	temazepam
0406-9960	TEMAZEPAM	temazepam
0406-9961	TEMAZEPAM	temazepam
0406-9962	TEMAZEPAM	temazepam
0440-8474	temazepam	temazepam
0440-8475	temazepam	temazepam
0440-8476	temazepam	temazepam
0440-8477	temazepam	temazepam
0615-7808	Temazepam	Temazepam
0615-7809	Temazepam	Temazepam