67296-0505 : Atropine Sulfate 0.025 mg / Diphenoxylate Hydrochloride 2.5 mg Oral Tablet

NDC:	67296-0505
Labeler:	Redpharm Drug, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Diphenoxylate Hydrochloride and Atropine Sulfate
Dosage Form:	Oral Tablet
Application #:	ANDA085762
Rev. Date:	Nov 30, 2010
CSA Schedule:	CV (US) [1]

^[1] Schedule V Controlled Substance: Low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics. (i.e. Cough preparations containing not more than 200 milligrams of Codeine per 100 milliliters or per 100 grams [such as Robitussin AC, Phenergan with Codeine], and Ezogabine). More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:

Markings:	M;15
Shapes:	Round
Colors:	White
Size (mm):	6
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:

• 67296-0505-1: 15 TABLET IN 1 BOTTLE (67296‑0505‑1)

Active Ingredients:

• Atropine Sulfate
• Diphenoxylate Hydrochloride

Inactive Ingredients:

• Silicon Dioxide
• Cellulose, Microcrystalline
• Starch, Corn
• Stearic Acid

Pharmaceutical Classes:

• Antidiarrheal [EPC]
• Anticholinergic [EPC]
• Cholinergic Antagonists [MoA]
• Cholinergic Muscarinic Antagonist [EPC]
• Cholinergic Muscarinic Antagonists [MoA]

Related Products:

Based on records with the same trade name.

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