NDC 0378-4415

Flurazepam Hydrochloride

Flurazepam Hydrochloride

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

• Product ID: 0378-4415_26b37269-88d6-4976-93df-209f0355902b
• NDC: 0378-4415
• Product Type: Human Prescription Drug
• Proprietary Name: Flurazepam Hydrochloride
• Generic Name: Flurazepam Hydrochloride
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 1985-11-27
• Marketing End Date: 2023-01-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA070345
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: FLURAZEPAM HYDROCHLORIDE
• Active Ingredient Strength: 15 mg/1
• Pharm Classes: Benzodiazepine [EPC],Benzodiazepines [CS]
• DEA Schedule: CIV
• NDC Exclude Flag: N

Packaging

NDC 0378-4415-01

100 CAPSULE in 1 BOTTLE, PLASTIC (0378-4415-01)

• Marketing Start Date: 1985-11-27
• Marketing End Date: 2023-01-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-4415-01 [00378441501]

Flurazepam Hydrochloride CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA070345
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1985-11-27

NDC 0378-4415-05 [00378441505]

Flurazepam Hydrochloride CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA070345
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1985-11-27
• Marketing End Date: 2013-06-21

Drug Details

Active Ingredients

Ingredient	Strength
FLURAZEPAM HYDROCHLORIDE	15 mg/1

OpenFDA Data

• SPL SET ID: 2f2db2f5-49d3-4d47-a08a-628df49d2120
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 756RDM536M
• RxNorm Concept Unique ID - RxCUI:
  • 1298091
  • 1298088

Pharmacological Class

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

NDC Crossover Matching brand name "Flurazepam Hydrochloride" or generic name "Flurazepam Hydrochloride"

NDC	Brand Name	Generic Name
0378-4415	Flurazepam Hydrochloride	flurazepam hydrochloride
0378-4430	Flurazepam Hydrochloride	flurazepam hydrochloride
55289-038	Flurazepam Hydrochloride	flurazepam hydrochloride
0143-3367	Flurazepam	Flurazepam Hydrochloride
0143-3370	Flurazepam	Flurazepam Hydrochloride
21695-363	Flurazepam	Flurazepam Hydrochloride
52959-236	Flurazepam	Flurazepam Hydrochloride
68788-0408	Flurazepam	Flurazepam Hydrochloride