50090-5589 : Diphenoxylate Hydrochloride and Atropine Sulfate Oral Tablet


NDC: 50090-5589
Labeler: A-s Medication Solutions
Product Type: Human Prescription Drug
Drug Name: Diphenoxylate Hydrochloride and Atropine Sulfate
Dosage Form: Oral Tablet
Application #: ANDA213413
Rev. Date: 
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.

NDC Package Codes:

  • 50090-5589-0: 15 TABLET IN 1 BOTTLE (50090‑5589‑0)
  • 50090-5589-1: 20 TABLET IN 1 BOTTLE (50090‑5589‑1)
  • 50090-5589-2: 30 TABLET IN 1 BOTTLE (50090‑5589‑2)

Active Ingredients:

  • Diphenoxylate Hydrochloride
  • Atropine Sulfate

Dosage Strength:

  • 2.5 mg
  • .025 mg

Pharmaceutical Classes:

  • Anticholinergic [EPC]
  • Antidiarrheal [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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  • 0832-0590 Diphenoxylate Hydrochloride and Atropine Sulfate Oral Tablet by Upsher-smith Laboratories, LLC
  • 12634-531 Atropine Sulfate 0.025 mg / Diphenoxylate Hydrochloride 2.5 mg Oral Tablet by Apotheca, Inc
  • 17856-1061 Diphenoxylate Hydrochloride and Atropine Sulfate Oral Tablet by Atlantic Biologicals Corps
  • 17856-3194 Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution by Atlantic Biologicals Corps
  • 21695-688 Atropine Sulfate 0.025 mg / Diphenoxylate Hydrochloride 2.5 mg Oral Tablet by Rebel Distributors Corp
  • 24236-983 Diphenoxylate Hydrochloride and Atropine Sulfate Oral Tablet by Remedyrepack Inc.
  • 33261-685 Diphenoxylate Hydrochloride and Atropine Sulfate Oral Tablet by Aidarex Pharmaceuticals LLC
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NDC 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.