0378-4415 : Flurazepam Hydrochloride 15 mg Oral Capsule


NDC: 0378-4415
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Flurazepam Hydrochloride
Dosage Form: Oral Capsule
Application #: ANDA070345
Rev. Date: 
CSA Schedule: CIV (US) [1]


[1] Schedule IV Controlled Substance: Low potential for abuse relative to substances in Schedule III. Examples include Alprazolam (Xanax), Diazepam (Valium), Carisoprodol (Soma), Clonazepam (Klonopin), Lorazepam (Ativan), Clorazepate (Tranxene), Midazolam (Versed), Temazepam (Restoril), and Triazolam (Halcion).. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:


Markings: MYLAN;4415
Shapes:  Capsule
Colors:  White / Blue
Size (mm): 15
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

MYLAN 4415: (0378-4415) Flurazepam Hydrochloride 15 mg Oral Capsule by Mylan Pharmaceuticals Inc.
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 0378-4415-01: 100 CAPSULE IN 1 BOTTLE, PLASTIC (0378‑4415‑01)

Active Ingredients:

  • Flurazepam Hydrochloride

Dosage Strength:

  • 15 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Powdered Cellulose
  • Sodium Lauryl Sulfate
  • Fd&c Blue No. 1
  • Fd&c Red No. 3
  • Gelatin
  • Titanium Dioxide
  • Ferrosoferric Oxide
  • D&c Yellow No. 10
  • Fd&c Blue No. 2
  • Fd&c Red No. 40
  • Propylene Glycol
  • Shellac

Pharmaceutical Classes:

  • Benzodiazepine [EPC]
  • Benzodiazepines [Chemical/Ingredient]

Related Products:

Based on records with the same trade name.
  • 0378-4430 Flurazepam Hydrochloride 30 mg Oral Capsule by Mylan Pharmaceuticals Inc.
  • 54868-0092 Flurazepam Hydrochloride 15 mg Oral Capsule by Physicians Total Care, Inc.
  • 54868-0093 Flurazepam Hydrochloride 30 mg Oral Capsule by Physicians Total Care, Inc.
  • 55289-038 Flurazepam Hydrochloride 30 mg Oral Capsule by Pd-rx Pharmaceuticals, Inc.
  • 62135-736 Flurazepam Hydrochloride 15 mg Oral Capsule by Chartwell Rx, LLC
  • 62135-737 Flurazepam Hydrochloride 30 mg Oral Capsule by Chartwell Rx, LLC

NDC QR Code

Scan the QR code below to easily reference this data in the future:

NDC 0378-4415 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.