69189-0116 : Zolpidem Tartrate Extended-release 12.5 mg Oral Tablet, Film Coated, Extended Release

NDC:	69189-0116
Labeler:	Avera Mckennan Hospital
Product Type:	Human Prescription Drug
Drug Name:	Zolpidem Tartrate Extended-release
Dosage Form:	Oral Tablet, Film Coated, Extended Release
Application #:	ANDA078148
Rev. Date:	Jun 29, 2015
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:	A116
Shapes:	Round
Colors:	White
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.

NDC Package Codes:

69189-0116-1: 1 TABLET, FILM COATED, EXTENDED RELEASE IN 1 DOSE PACK (69189‑0116‑1)

Active Ingredients:

Zolpidem Tartrate

Dosage Strength:

12.5 mg

Inactive Ingredients:

Silicon Dioxide
Hypromelloses
Magnesium Stearate
Polyethylene Glycols
Sucrose
Titanium Dioxide
Polydextrose
Triacetin

Pharmaceutical Classes:

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

NDC QR Code

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NDC 69189-0116 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.