43063-957 : Diphenoxylate Hydrochloride and Atropine Sulfate Oral Tablet


NDC: 43063-957
Labeler: Pd-rx Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name: Diphenoxylate Hydrochloride and Atropine Sulfate
Dosage Form: Oral Tablet
Application #: ANDA210571
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.

Appearance:


Markings: U;S;90
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.

NDC Package Codes:

  • 43063-957-04: 4 TABLET IN 1 BOTTLE, PLASTIC (43063‑957‑04)
  • 43063-957-10: 10 TABLET IN 1 BOTTLE, PLASTIC (43063‑957‑10)
  • 43063-957-15: 15 TABLET IN 1 BOTTLE, PLASTIC (43063‑957‑15)
  • 43063-957-20: 20 TABLET IN 1 BOTTLE, PLASTIC (43063‑957‑20)

Active Ingredients:

  • Atropine Sulfate
  • Diphenoxylate Hydrochloride

Dosage Strength:

  • 2.5 mg
  • .025 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Microcrystalline Cellulose
  • 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.
  • 43063-089 Atropine Sulfate 0.025 mg / Diphenoxylate Hydrochloride 2.5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 55289-102 Atropine Sulfate 0.025 mg / Diphenoxylate Hydrochloride 2.5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 72789-375 Diphenoxylate Hydrochloride and Atropine Sulfate Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 0054-3194 Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution by Roxane Laboratories, Inc
  • 0179-0276 Diphenoxylate Hydrochloride and Atropine Sulfate Oral Tablet by Kaiser Foundation Hospitals
  • 0378-0415 Atropine Sulfate 0.025 mg / Diphenoxylate Hydrochloride 2.5 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0406-1236 Diphenoxylate Hydrochloride and Atropine Sulfate Oral Tablet by Specgx LLC
  • 0527-1170 Atropine Sulfate 0.025 mg / Diphenoxylate Hydrochloride 2.5 mg Oral Tablet by Lannett Co., Inc.
  • 0615-7801 Diphenoxylate Hydrochloride and Atropine Sulfate Oral Tablet by Ncs Healthcare of Ky, Inc Dba Vangard Labs
  • 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
  • 43353-083 Diphenoxylate Hydrochloride and Atropine Sulfate Oral Tablet by Aphena Pharma Solutions - Tennessee, LLC
  • 43353-594 Diphenoxylate Hydrochloride and Atropine Sulfate Oral Tablet by Aphena Pharma Solutions - Tennessee, LLC
  • 49884-771 Atropine Sulfate 0.025 mg / Diphenoxylate Hydrochloride 2.5 mg Oral Tablet by Par Pharmaceutical, Inc.
  • 49999-207 Atropine Sulfate 0.025 mg / Diphenoxylate Hydrochloride 2.5 mg Oral Tablet by Lake Erie Medical & Surgical Supply Dba Quality Care Products LLC
  • More related products ...

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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.