43353-711 : Temazepam 7.5 mg Oral Capsule

NDC:	43353-711
Labeler:	Aphena Pharma Solutions - Tennessee, LLC
Product Type:	Human Prescription Drug
Drug Name:	Temazepam
Dosage Form:	Oral Capsule
Application #:	ANDA070920
Rev. Date:	Oct 25, 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:	MYLAN;3110
Shapes:	Capsule
Colors:	Orange / White
Size (mm):	14
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 3110: (43353-711) Temazepam 7.5 mg Oral Capsule by Aphena Pharma Solutions - Tennessee, LLC

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:

43353-711-30: 30 CAPSULE IN 1 BOTTLE, PLASTIC (43353‑711‑30)
43353-711-53: 60 CAPSULE IN 1 BOTTLE, PLASTIC (43353‑711‑53)
43353-711-60: 90 CAPSULE IN 1 BOTTLE, PLASTIC (43353‑711‑60)

Active Ingredients:

Temazepam

Dosage Strength:

7.5 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]

NDC QR Code

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NDC 43353-711 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.