0378-3120 : Temazepam 22.5 mg Oral Capsule


NDC: 0378-3120
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Temazepam
Dosage Form: Oral Capsule
Application #: ANDA070920
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;3120
Shapes:  Capsule
Colors:  Yellow / Orange
Size (mm): 16
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.

NDC Package Codes:

  • 0378-3120-01: 100 CAPSULE IN 1 BOTTLE, PLASTIC (0378‑3120‑01)
  • 0378-3120-05: 500 CAPSULE IN 1 BOTTLE, PLASTIC (0378‑3120‑05)
  • 0378-3120-93: 30 CAPSULE IN 1 BOTTLE, PLASTIC (0378‑3120‑93)

Active Ingredients:

  • Temazepam

Dosage Strength:

  • 22.5 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Powdered Cellulose
  • Sodium Lauryl Sulfate
  • Fd&c Yellow No. 6
  • Gelatin
  • Titanium Dioxide
  • D&c Yellow No. 10
  • Ferrosoferric Oxide
  • Fd&c Blue No. 1
  • Fd&c Blue No. 2
  • Fd&c Red No. 40
  • Propylene Glycol
  • Shellac

Pharmaceutical Classes:

  • Benzodiazepine [EPC]
  • Benzodiazepines [CS]

Related Products:

Based on records with the same trade name.
  • 0378-3110 Temazepam 7.5 mg Oral Capsule by Mylan Pharmaceuticals Inc.
  • 0378-4010 Temazepam 15 mg Oral Capsule by Mylan Pharmaceuticals Inc.
  • 0378-5050 Temazepam 30 mg Oral Capsule by Mylan Pharmaceuticals Inc.
  • 0179-0045 Temazepam 7.5 mg Oral Capsule by Kaiser Foundation Hospitals
  • 0179-1470 Temazepam 15 mg Oral Capsule by Kaiser Foundation Hospitals
  • 0228-2076 Temazepam 15 mg Oral Capsule by Actavis Elizabeth LLC
  • 0228-2077 Temazepam 30 mg Oral Capsule by Actavis Elizabeth LLC
  • 0406-9959 Temazepam 22.5 mg Oral Capsule by Mallinckrodt, Inc.
  • 0406-9960 Temazepam 7.5 mg Oral Capsule by Mallinckrodt, Inc.
  • 0406-9961 Temazepam 15 mg Oral Capsule by Specgx LLC
  • 0406-9962 Temazepam 30 mg Oral Capsule by Specgx LLC
  • 0440-8474 Temazepam 7.5 mg Oral Capsule by Liberty Pharmaceuticals, Inc.
  • 0440-8475 Temazepam 15 mg Oral Capsule by Liberty Pharmaceuticals, Inc.
  • 0440-8476 Temazepam 30 mg Oral Capsule by Liberty Pharmaceuticals, Inc.
  • 0440-8477 Temazepam 22.5 mg Oral Capsule by Liberty Pharmaceuticals, Inc.
  • 0603-5891 Temazepam 7.5 mg Oral Capsule by Qualitest Pharmaceuticals
  • 0603-5892 Temazepam 15 mg Oral Capsule by Qualitest Pharmaceuticals
  • 0603-5893 Temazepam 22.5 mg Oral Capsule by Qualitest Pharmaceuticals
  • 0603-5894 Temazepam 30 mg Oral Capsule by Qualitest Pharmaceuticals
  • 0615-7808 Temazepam 15 mg Oral Capsule by Ncs Healthcare of Ky, Inc Dba Vangard Labs
  • More related products ...

NDC 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.