43353-727 : Zolpidem Tartrate 12.5 mg Oral Tablet, Film Coated, Extended Release

NDC:	43353-727
Labeler:	Aphena Pharma Solutions - Tennessee, LLC
Product Type:	Human Prescription Drug
Drug Name:	Zolpidem Tartrate
Dosage Form:	Oral Tablet, Film Coated, Extended Release
Application #:	NDA021774
Rev. Date:	Dec 6, 2010
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:	ZCR
Shapes:	Round
Colors:	Blue
Size (mm):	8
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.

ZCR: (43353-727) Zolpidem Tartrate 12.5 mg Oral Tablet, Film Coated, Extended Release 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:

43353-727-30: 30 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (43353‑727‑30)
43353-727-60: 90 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (43353‑727‑60)

Active Ingredients:

Zolpidem Tartrate

Dosage Strength:

12.5 mg

Inactive Ingredients:

Silicon Dioxide
Fd&c Blue No. 2
Hypromelloses
Lactose Monohydrate
Magnesium Stearate
Cellulose, Microcrystalline
Polyethylene Glycols
Potassium Bitartrate
Titanium Dioxide
Ferric Oxide Yellow

Pharmaceutical Classes:

Central Nervous System Depression [PE]
GABA A Agonists [MoA]
Pyridines [CS]
gamma-Aminobutyric Acid-ergic Agonist [EPC]

NDC QR Code

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NDC 43353-727 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.