68788-9865 : Temazepam 15 mg Oral Capsule

NDC:	68788-9865
Labeler:	Preferred Pharmaceuticals, Inc
Product Type:	Human Prescription Drug
Drug Name:	Temazepam
Dosage Form:	Oral Capsule
Application #:	ANDA071456
Rev. Date:	Feb 28, 2012
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:	15mg;Novel121
Shapes:	Capsule
Colors:	Blue / White
Size (mm):	19
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:

• 68788-9865-1: 100 CAPSULE IN 1 BOTTLE (68788‑9865‑1)
• 68788-9865-3: 30 CAPSULE IN 1 BOTTLE (68788‑9865‑3)
• 68788-9865-6: 60 CAPSULE IN 1 BOTTLE (68788‑9865‑6)
• 68788-9865-9: 90 CAPSULE IN 1 BOTTLE (68788‑9865‑9)

Active Ingredients:

• Temazepam

Inactive Ingredients:

• Starch, Corn
• Anhydrous Lactose
• Magnesium Stearate
• Fd&c Blue No. 1
• Fd&c Yellow No. 6
• Gelatin
• Titanium Dioxide
• Sodium Lauryl Sulfate
• Ammonia
• Alcohol
• Isopropyl Alcohol
• Butyl Alcohol
• Shellac
• Potassium Hydroxide
• Propylene Glycol
• Ferrosoferric Oxide

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

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