Data / Drug companies / Diphenoxylate hydrochloride and atropine sulfate
Diphenoxylate hydrochloride and atropine sulfate: 22 companies and 28 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Diphenoxylate hydrochloride and atropine sulfate is listed in the FDA National Drug Code Directory by 22 companies, with 28 products in commercial distribution. 25 of the products (89.3%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet; solution, and the newest product started marketing on August 1, 2025.
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- Companies listing it
- 22
- Products
- 28
- Generic (ANDA) products
- 25 (89.3%)
- Application numbers
- 8
- Controlled substance schedule
- Schedule V
- Routes
- Oral
- Brand names
- Lomotil
- openFDA record search
- api.fda.gov
Companies that list diphenoxylate hydrochloride and atropine sulfate
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| A-S Medication Solutions | 3 | tablet | Generic drugs (ANDA) | March 15, 2020 |
| Aphena Pharma Solutions - Tennessee, LLC | 2 | tablet | Generic drugs (ANDA) | October 30, 2020 |
| Aphena Pharma Solutions - Tennessee, LLC | 2 | tablet | Authorized generics (NDA) | June 20, 2017 |
| Bryant Ranch Prepack | 2 | tablet | Generic drugs (ANDA) | March 15, 2020 |
| Redpharm Drug | 2 | tablet | Generic drugs (ANDA) | March 15, 2020 |
| American Health Packaging | 1 | tablet | Generic drugs (ANDA) | August 1, 2025 |
| Ani Pharmaceuticals, Inc. | 1 | tablet | Generic drugs (ANDA) | July 7, 2017 |
| Chartwell RX, LLC | 1 | tablet | Generic drugs (ANDA) | October 21, 2020 |
| Direct_Rx | 1 | tablet | Generic drugs (ANDA) | March 7, 2022 |
| Hikma Pharmaceuticals USA Inc. | 1 | solution | Generic drugs (ANDA) | May 3, 1982 |
| Leading Pharma, LLC | 1 | tablet | Generic drugs (ANDA) | March 15, 2020 |
| Mylan Pharmaceuticals Inc. | 1 | tablet | Authorized generics (NDA) | August 7, 2012 |
| NuCare Pharmaceuticals,Inc. | 1 | tablet | Generic drugs (ANDA) | June 20, 2017 |
| PD-Rx Pharmaceuticals, Inc. | 1 | tablet | Generic drugs (ANDA) | March 15, 2020 |
| Pfizer Laboratories Div Pfizer Inc | 1 | tablet | New drug applications (NDA) | September 15, 1960 |
| Preferred Pharmaceuticals Inc. | 1 | tablet | Generic drugs (ANDA) | October 6, 2021 |
| Proficient Rx LP | 1 | tablet | Generic drugs (ANDA) | March 15, 2020 |
| Proficient Rx LP | 1 | tablet | Generic drugs (ANDA) | July 7, 2017 |
| Remedyrepack Inc. | 1 | tablet | Generic drugs (ANDA) | November 16, 2023 |
| SpecGx LLC | 1 | tablet | Generic drugs (ANDA) | October 30, 2020 |
| Unichem Pharmaceuticals (USA), Inc. | 1 | tablet | Generic drugs (ANDA) | May 15, 2019 |
| Winder Laboratories LLC | 1 | tablet | Generic drugs (ANDA) | April 30, 2022 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 27 | 96.4% |
| Solution | 1 | 3.6% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 25 | 89.3% |
| Authorized generics (NDA) | 2 | 7.1% |
| New drug applications (NDA) | 1 | 3.6% |
Pharmacologic classes
| Class | Products |
|---|---|
| Anticholinergic | 28 |
| Antidiarrheal | 28 |
| Cholinergic Muscarinic Antagonist | 28 |
CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.