0025-0061 : Lomotil (Atropine Sulfate 0.025 mg / Diphenoxylate Hydrochloride 2.5 mg) Oral Tablet

Labeler: G.d. Searle LLC Division of Pfizer Inc
Product Type: Human Prescription Drug
Drug Name:  Lomotil
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.


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: (0025-0061) Lomotil (Atropine Sulfate 0.025 mg / Diphenoxylate Hydrochloride 2.5 mg) Oral Tablet by G.d. Searle LLC Division of Pfizer Inc
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:

  • 0025-0061-31: 100 TABLET IN 1 BOTTLE (0025‑0061‑31)
  • 0025-0061-34: 100 TABLET IN 1 CARTON (0025‑0061‑34)
  • 0025-0061-51: 500 TABLET IN 1 BOTTLE (0025‑0061‑51)
  • 0025-0061-52: 1000 TABLET IN 1 BOTTLE (0025‑0061‑52)
  • 0025-0061-55: 2500 TABLET IN 1 BOTTLE (0025‑0061‑55)

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:

  • 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.
  • 54868-0427 Lomotil (Atropine Sulfate 0.025 mg / Diphenoxylate Hydrochloride 2.5 mg) Oral Tablet by Physicians Total Care, Inc.
  • 67296-1210 Lomotil Oral Tablet by Redpharm Drug, Inc.


Scan the QR code below to easily reference this data in the future:

NDC 0025-0061 QR Code

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