52125-881 : Temazepam 15 mg Oral Capsule

NDC:	52125-881
Labeler:	Remedyrepack Inc.
Product Type:	Human Prescription Drug
Drug Name:	Temazepam
Dosage Form:	Oral Capsule
Application #:	ANDA070920
Rev. Date:	Mar 24, 2014
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;4010
Shapes:	Capsule
Colors:	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.

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:

• 52125-881-02: 30 CAPSULE IN 1 BLISTER PACK (52125‑881‑02)

Active Ingredients:

• Temazepam

Inactive Ingredients:

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

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

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