Drug
Who makes diclofenac?
11 companies list diclofenac as a human prescription drug, including under the names Xiclo. Forms: patch; solution; tablet, delayed release. Routes: oral, topical, transdermal.
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 diclofenac
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | patch; solution | ANDA, UNAPPROVED DRUG OTHERANDA206116 | 2 | 1 |
| Amneal Ireland LimitedIreland | solution | ANDAANDA206116, ANDA208198 | 2 | 1 |
| Encube Ethicals LimitedIndia | solution | ANDAANDA217646 | 1 | 5 |
| International Medication Systems, Ltd.United States | solution | ANDAANDA206116 | 1 | 3 |
| ADVANCED RX PHARMACY OF TENNESSEE LLCUnited States | solution | ANDAANDA208198 | 1 | 1 |
| Bryant Ranch PrepackUnited States | solution | ANDAANDA206116 | 1 | 1 |
| PHOENIX RX LLCUnited States | solution | ANDAANDA206116 | 1 | 1 |
| Preferred Pharmaceuticals Inc.United States | solution | ANDAANDA206116 | 1 | 1 |
| Proficient Rx LPUnited States | solution | ANDAANDA206116 | 1 | 1 |
| Advanced Rx of Tennessee, LLC | tablet, delayed release | ANDAANDA077863 | 1 | 0 |
| Strand Health Group | patch | UNAPPROVED DRUG OTHER | 1 | 0 |
Bulk ingredient listings
- Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.)India · 1 NDC
- Unique Chemicals · 1 NDC
Orange Book patents
7 unexpired patents list diclofenac as the active ingredient, expiring between Apr 2030 and Apr 2030. Application holder: ZYLA LIFE SCIENCES US INC.
Enquiry
Common questions
- Who makes diclofenac?
- 11 companies list diclofenac as a human prescription drug in the openFDA NDC Directory, led by ASCLEMED USA INC. DBA ENOVACHEM, Amneal Ireland Limited, Encube Ethicals Limited, International Medication Systems, Ltd., ADVANCED RX PHARMACY OF TENNESSEE LLC. 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 diclofenac?
- 10 companies list diclofenac under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies diclofenac active ingredient?
- 2 companies list diclofenac as a bulk ingredient, including Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.), Unique Chemicals.