54868-5461 : Ambien CR 6.25 mg Extended Release Tablet

NDC:	54868-5461
Labeler:	Physicians Total Care, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Ambien CR
Dosage Form:	Oral Tablet, Coated
Application #:	NDA021774
Rev. Date:	Oct 7, 2005
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:	A;
Shapes:	Round
Colors:	Pink
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.

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:

• 54868-5461-0: 10 TABLET, COATED IN 1 BOTTLE, PLASTIC (54868‑5461‑0)
• 54868-5461-1: 30 TABLET, COATED IN 1 BOTTLE, PLASTIC (54868‑5461‑1)

Active Ingredients:

• Zolpidem Tartrate

Inactive Ingredients:

• Silicon Dioxide
• Hypromelloses
• Lactose Monohydrate
• Magnesium Stearate
• Cellulose, Microcrystalline
• Polyethylene Glycols
• Potassium Bitartrate
• Ferric Oxide Red
• Titanium Dioxide

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 54868-5426 Ambien CR 12.5 mg Extended Release Tablet by Physicians Total Care, Inc.
• 21695-213 Ambien CR 12.5 mg Extended Release Tablet by Rebel Distributors Corp.
• 21695-319 Ambien CR 6.25 mg Extended Release Tablet by Rebel Distributors Corp.
• 60760-551 Ambien CR 12.5 mg Extended Release Tablet by St Marys Medical Park Pharmacy
• 63629-3141 Ambien CR 12.5 mg Extended Release Tablet by Bryant Ranch Prepack
• 63629-3337 Ambien CR 6.25 mg Extended Release Tablet by Bryant Ranch Prepack

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