54868-0427 : Lomotil (Atropine Sulfate 0.025 mg / Diphenoxylate Hydrochloride 2.5 mg) Oral Tablet
| NDC: | 54868-0427 |
| Labeler: | Physicians Total Care, 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.
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. | |
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:
- 54868-0427-0: 100 TABLET IN 1 BOTTLE (54868‑0427‑0)
- 54868-0427-3: 30 TABLET IN 1 BOTTLE (54868‑0427‑3)
- 54868-0427-4: 12 TABLET IN 1 BOTTLE (54868‑0427‑4)
- 54868-0427-5: 10 TABLET IN 1 BOTTLE (54868‑0427‑5)
Active Ingredients:
- Atropine Sulfate
- Diphenoxylate Hydrochloride
Dosage Strength:
- .025 mg
- 2.5 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.- 0025-0061 Lomotil (Atropine Sulfate 0.025 mg / Diphenoxylate Hydrochloride 2.5 mg) Oral Tablet by G.d. Searle LLC Division of Pfizer Inc
- 67296-1210 Lomotil Oral Tablet by Redpharm Drug, Inc.
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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.