43353-083 : Diphenoxylate Hydrochloride and Atropine Sulfate Oral Tablet


NDC43353-083
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Product Type: Human Prescription Drug
Drug Name: Diphenoxylate Hydrochloride and Atropine Sulfate
Dosage Form: Oral Tablet
Application #: NDA012462
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: SEARLE;61
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.

SEARLE 61: (59762-1061) Diphenoxylate Hydrochloride and Atropine Sulfate Oral Tablet by Aphena Pharma Solutions - Tennessee, 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:

  • 43353-083-30: 30 TABLET IN 1 BOTTLE (43353‑083‑30)
  • 43353-083-53: 60 TABLET IN 1 BOTTLE (43353‑083‑53)
  • 43353-083-60: 90 TABLET IN 1 BOTTLE (43353‑083‑60)
  • 43353-083-70: 120 TABLET IN 1 BOTTLE (43353‑083‑70)
  • 43353-083-80: 180 TABLET IN 1 BOTTLE (43353‑083‑80)
  • 43353-083-90: 240 TABLET IN 1 BOTTLE (43353‑083‑90)

Active Ingredients:

  • Diphenoxylate Hydrochloride
  • Atropine Sulfate

Dosage Strength:

  • 2.5 mg
  • .025 mg

Inactive Ingredients:

  • Acacia
  • Starch, Corn
  • Magnesium Stearate
  • Sorbitol
  • Sucrose
  • Talc

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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  • 43063-957 Diphenoxylate Hydrochloride and Atropine Sulfate Oral Tablet by Pd-rx Pharmaceuticals, Inc.
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