0228-3481 : Zolpidem Tartrate 6.25 mg Extended Release Tablet

NDC:	0228-3481
Labeler:	Actavis Elizabeth LLC
Product Type:	Human Prescription Drug
Drug Name:	Zolpidem Tartrate
Dosage Form:	Oral Tablet, Film Coated, Extended Release
Application #:	ANDA078179
Rev. Date:	Oct 14, 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:	A2
Shapes:	Round
Colors:	White
Size (mm):	7
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.

A2: (0228-3481) Zolpidem Tartrate 6.25 mg Extended Release Tablet by Actavis Elizabeth 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:

0228-3481-11: 100 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (0228‑3481‑11)
0228-3481-50: 500 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (0228‑3481‑50)

Active Ingredients:

Zolpidem Tartrate

Dosage Strength:

6.25 mg

Inactive Ingredients:

Silicon Dioxide
Hypromelloses
Anhydrous Lactose
Magnesium Stearate
Polyethylene Glycols
Tartaric Acid
Sodium Bicarbonate
Povidone
Cellulose, Microcrystalline
Sodium Lauryl Sulfate
Talc
Titanium Dioxide
Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)
Triethyl Citrate
Polyvinyl Alcohol

Pharmaceutical Classes:

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

NDC QR Code

Scan the QR code below to easily reference this data in the future:

NDC 0228-3481 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.