NDC 61825-165

Doral

Quazepam

Doral is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Galt Pharmaceuticals Llc. The primary component is Quazepam.

• Product ID: 61825-165_26b22a08-e663-4770-8a5d-865aa208fe5a
• NDC: 61825-165
• Product Type: Human Prescription Drug
• Proprietary Name: Doral
• Generic Name: Quazepam
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2017-07-19
• Marketing Category: NDA / NDA
• Application Number: NDA018708
• Labeler Name: Galt Pharmaceuticals LLC
• Substance Name: QUAZEPAM
• Active Ingredient Strength: 15 mg/1
• Pharm Classes: Benzodiazepine [EPC],Benzodiazepines [CS]
• DEA Schedule: CIV
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 61825-165-10

100 TABLET in 1 BOTTLE (61825-165-10)

• Marketing Start Date: 2017-07-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61825-165-30 [61825016530]

DORAL TABLET

• Marketing Category: NDA
• Application Number: NDA018708
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-12-04

NDC 61825-165-10 [61825016510]

DORAL TABLET

• Marketing Category: NDA
• Application Number: NDA018708
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-07-19

Drug Details

Active Ingredients

Ingredient	Strength
QUAZEPAM	15 mg/1

OpenFDA Data

• SPL SET ID: 9727e8b4-14f1-451d-9630-84eabc772e42
• Manufacturer:
  • Galt Pharmaceuticals LLC
• UNII:
  • JF8V0828ZI
• RxNorm Concept Unique ID - RxCUI:
  • 207889
  • 198183

Pharmacological Class

• Benzodiazepine [EPC]
• Benzodiazepines [CS]

NDC Crossover Matching brand name "Doral" or generic name "Quazepam"

NDC	Brand Name	Generic Name
61825-165	Doral	Quazepam
50090-1474	Quazepam	QUAZEPAM
71993-265	Quazepam	Quazepam