50090-0040 : Diphenoxylate Hydrochloride and Atropine Sulfate Oral Tablet

NDC:	50090-0040
Labeler:	A-s Medication Solutions LLC
Product Type:	Human Prescription Drug
Drug Name:	Diphenoxylate Hydrochloride and Atropine Sulfate
Dosage Form:	Oral Tablet
Application #:	ANDA085762
Rev. Date:	Nov 17, 1977
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.

M 15: (0378-0415) Diphenoxylate Hydrochloride and Atropine Sulfate Oral Tablet by A-s Medication Solutions 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:

50090-0040-0: 20 TABLET IN 1 BOTTLE, PLASTIC (50090‑0040‑0)

Active Ingredients:

Atropine Sulfate
Diphenoxylate Hydrochloride

Dosage Strength:

2.5 mg
.025 mg

Inactive Ingredients:

Silicon Dioxide
Cellulose, Microcrystalline
Starch, Corn
Stearic Acid

Pharmaceutical Classes:

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

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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.