Drug
Who makes diphenoxylate hydrochloride and atropine sulfate?
20 companies list diphenoxylate hydrochloride and atropine sulfate as a human prescription drug, including under the names Lomotil. Forms: solution; tablet. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing diphenoxylate hydrochloride and atropine sulfate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Aphena Pharma Solutions - Tennessee, LLC | tablet | ANDA, NDA AUTHORIZED GENERICANDA086727, ANDA213335, ANDA213413 | 4 | 0 |
| International Medication Systems, Ltd.United States | tablet | ANDAANDA086727, ANDA213413 | 3 | 3 |
| Bryant Ranch PrepackUnited States | tablet | ANDAANDA086727, ANDA213413 | 2 | 1 |
| Proficient Rx LPUnited States | tablet | ANDAANDA086727, ANDA213413 | 2 | 1 |
| RedPharm DrugUnited States | tablet | ANDAANDA213413 | 2 | 1 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet | ANDAANDA213335 | 1 | 5 |
| SpecGx LLCUnited States | tablet | ANDAANDA213335 | 1 | 5 |
| Unichem Laboratories Limited, IndiaIndia | tablet | ANDAANDA210819 | 1 | 5 |
| Hikma Pharmaceuticals USA Inc.United States | solution | ANDAANDA087708 | 1 | 4 |
| ANI Pharmaceuticals, Inc.United States | tablet | ANDAANDA086727 | 1 | 1 |
| Direct RxUnited States | tablet | ANDAANDA213413 | 1 | 1 |
| Leading Pharma, LLCUnited States | tablet | ANDAANDA213413 | 1 | 1 |
| NuCare Pharmaceuticals,Inc.United States | tablet | ANDAANDA086727 | 1 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | tablet | ANDAANDA213413 | 1 | 1 |
| Preferred Pharmaceuticals Inc.United States | tablet | ANDAANDA213413 | 1 | 1 |
| RemedyRepack, IncUnited States | tablet | ANDAANDA213413 | 1 | 1 |
| WINDER LABORATORIES, LLCUnited States | tablet | ANDAANDA211362 | 1 | 1 |
| Chartwell RX, LLC. | tablet | ANDAANDA207128 | 1 | 0 |
| Mylan Pharmaceuticals, Inc. | tablet | NDA AUTHORIZED GENERICNDA012462 | 1 | 0 |
| Pfizer Laboratories Div Pfizer Inc | tablet | NDANDA012462 | 1 | 0 |
Bulk ingredient listings
- KALINTIS HEALTHCARE PRIVATE LIMITEDIndia · 1 NDC
Enquiry
Common questions
- Who makes diphenoxylate hydrochloride and atropine sulfate?
- 20 companies list diphenoxylate hydrochloride and atropine sulfate as a human prescription drug in the openFDA NDC Directory, led by Aphena Pharma Solutions - Tennessee, LLC, International Medication Systems, Ltd., Bryant Ranch Prepack, Proficient Rx LP, RedPharm Drug. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Lomotil?
- 18 companies list diphenoxylate hydrochloride and atropine sulfate under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies diphenoxylate hydrochloride and atropine sulfate active ingredient?
- 1 company lists diphenoxylate hydrochloride and atropine sulfate as a bulk ingredient, including KALINTIS HEALTHCARE PRIVATE LIMITED.