Drug
Who makes diclofenac sodium?
48 companies list diclofenac sodium as a human prescription drug. Forms: gel; solution; solution/ drops; tablet, delayed release; tablet, extended release; tablet, film coated; tablet, film coated, extended release. Routes: ophthalmic, 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 sodium
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| International Medication Systems, Ltd.United States | gel; solution; solution/ drops; tablet, delayed release | ANDAANDA074514, ANDA075185, ANDA075281 | 24 | 3 |
| Proficient Rx LPUnited States | gel; solution; solution/ drops; tablet, delayed release | ANDA, NDA AUTHORIZED GENERICANDA074514, ANDA075185, ANDA075492 | 21 | 1 |
| Bryant Ranch PrepackUnited States | gel; solution; tablet, delayed release; tablet, film coated | ANDAANDA075185, ANDA075492, ANDA077863 | 18 | 1 |
| NuCare Pharmaceuticals,Inc.United States | gel; tablet, delayed release; tablet, extended release; tablet, film coated, extended release | ANDAANDA075185, ANDA075281, ANDA075492 | 14 | 1 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | gel; solution; solution/ drops; tablet, delayed release | ANDAANDA077863, ANDA090066, ANDA200936 | 12 | 1 |
| Preferred Pharmaceuticals Inc.United States | gel; solution; tablet, delayed release | ANDAANDA075185, ANDA077863, ANDA090066 | 11 | 1 |
| RemedyRepack, IncUnited States | gel; solution; tablet, delayed release; tablet, film coated | ANDAANDA075185, ANDA075281, ANDA203818 | 10 | 1 |
| ADVANCED RX PHARMACY OF TENNESSEE LLCUnited States | gel; solution; tablet, delayed release; tablet, film coated, extended release | ANDAANDA075185, ANDA075492, ANDA200936 | 9 | 1 |
| Advanced Rx of Tennessee, LLC | solution; tablet, delayed release; tablet, film coated | ANDAANDA075185, ANDA090066, ANDA203818 | 9 | 0 |
| Golden State Medical Supply Inc.United States | tablet, delayed release | ANDAANDA074514, ANDA075185 | 7 | 1 |
| PHOENIX RX LLCUnited States | solution; tablet, delayed release | ANDAANDA075185, ANDA077863, ANDA207714 | 6 | 1 |
| Carlsbad Technology, Inc.United States | tablet, delayed release | ANDAANDA075185 | 5 | 1 |
| Direct RxUnited States | gel; solution | ANDAANDA203818, ANDA204132, ANDA206116 | 5 | 1 |
| Northwind Health Company, LLCUnited States | tablet, delayed release | ANDAANDA075185, ANDA075281 | 4 | 1 |
| Advagen Pharma Limited | solution; tablet, delayed release | ANDAANDA077600, ANDA216548 | 4 | 0 |
| BluePoint Laboratories Inc. | tablet, delayed release; tablet, film coated | ANDAANDA077863, ANDA090066, ANDA216275 | 4 | 0 |
| Northstar Rx, LLC, | solution; tablet, delayed release | ANDAANDA213040, ANDA216548 | 4 | 0 |
| Sun Pharmaceutical Industries LimitedIndia | gel; solution | ANDAANDA203818, ANDA206298, ANDA208098 | 3 | 13 |
| Aurobindo Pharma LimitedIndia | tablet, delayed release; tablet, film coated, extended release | ANDAANDA075281, ANDA076152 | 3 | 6 |
| Actavis LLCUnited States | gel; tablet, delayed release | ANDAANDA074514, ANDA206493 | 3 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | tablet, delayed release | ANDAANDA074514, ANDA077863 | 3 | 1 |
| RedPharm DrugUnited States | tablet, delayed release | ANDAANDA075185, ANDA216548 | 3 | 1 |
| Rising Pharma Holdings, Inc.United States | tablet, delayed release | ANDAANDA077863, ANDA090066 | 3 | 1 |
| UMEDICA LABORATORIES PRIVATE LIMITEDIndia | tablet, delayed release | ANDAANDA219945 | 3 | 1 |
| AvKARE | solution; tablet, delayed release | ANDAANDA075185, ANDA212506 | 3 | 0 |
| Quality Care Products, LLC | gel; solution | ANDAANDA202769, ANDA209903, ANDA212506 | 3 | 0 |
| Lupin LimitedIndia | solution | ANDAANDA205878, ANDA208021 | 2 | 14 |
| Alembic Pharmaceuticals LimitedIndia | solution | ANDAANDA212506 | 2 | 7 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet, delayed release | ANDAANDA077863, ANDA090066 | 2 | 5 |
| St. Mary's Medical Park PharmacyUnited States | tablet, delayed release; tablet, extended release | ANDAANDA076201, ANDA077863 | 2 | 1 |
| SOLA Pharmaceuticals, LLC | solution; tablet, delayed release | ANDAANDA075185, ANDA206116 | 2 | 0 |
| Sportpharm LLC | tablet, delayed release; tablet, film coated | ANDAANDA077863, ANDA216275 | 2 | 0 |
| Amneal Pharmaceuticals of New York, LLCIndia | gel | ANDAANDA200936 | 1 | 14 |
| Glenmark Pharmaceuticals Inc., USAIndia | gel | ANDAANDA208301 | 1 | 9 |
| Apotex Inc.Canada | solution | ANDAANDA207714 | 1 | 6 |
| Sandoz Industrial Products S.AAustria | solution | ANDAANDA078031 | 1 | 5 |
| Bausch & Lomb Ireland LimitedUnited States | solution/ drops | ANDAANDA078792 | 1 | 4 |
| Aurolife Pharma LLCUnited States | solution | ANDAANDA213040 | 1 | 3 |
| Padagis Israel Pharmaceuticals LtdUnited States | gel | ANDAANDA210893 | 1 | 2 |
| Altaire Pharmaceuticals Inc.United States | solution/ drops | ANDAANDA203383 | 1 | 1 |
| Coupler LLCUnited States | tablet, delayed release | ANDAANDA077863 | 1 | 1 |
| HAWAII REPACK INCUnited States | gel | ANDAANDA208301 | 1 | 1 |
| Novel Laboratories IncUnited States | solution | ANDAANDA205878 | 1 | 1 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet, delayed release | ANDAANDA074514 | 1 | 0 |
| DirectRx | solution | ANDAANDA203818 | 1 | 0 |
| Edenbridge Pharmaceuticals LLC. | tablet, extended release | ANDAANDA076201 | 1 | 0 |
| Ingenus Pharmaceuticals, LLC | tablet, film coated | ANDAANDA216275 | 1 | 0 |
| Oceanside Pharmaceuticals. | tablet, film coated, extended release | ANDAANDA075492 | 1 | 0 |
Bulk ingredient listings
- Dipharma Francis SrlItaly · 3 NDC
- MEDISCA Inc.United States · 2 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 2 NDC
- ASCLEMED USA INC. DBA ENOVACHEMUnited States · 1 NDC
- AX Pharmaceutical CorpCanada · 1 NDC
- Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.)India · 1 NDC
- Cheng Fong Chemical Co., Ltd.Taiwan · 1 NDC
- Fagron Services B.V.Netherlands · 1 NDC
- Galenova IncCanada · 1 NDC
- Henan Dongtai Pharm Co., Ltd.China · 1 NDC
- KREATIVE ACTIVES PRIVATE LIMITEDIndia · 1 NDC
- Kalchem International Inc.United States · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- Olon USA LLCItaly · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
- Syn-Tech Chem. & Pharm. Co., Ltd.Taiwan · 1 NDC
- Unique Chemicals · 1 NDC
- XENEX LABORATORIES INCCanada · 1 NDC
- YUNG ZIP CHEMICAL INDUSTRIAL .CO., LTD. · 1 NDC
Orange Book patents
20 unexpired patents list diclofenac sodium as the active ingredient, expiring between Mar 2027 and Aug 2030. Application holders: HORIZON THERAPEUTICS IRELAND DAC, JAVELIN PHARMACEUTICALS INC A WHOLLY OWNED SUDSIDIARY OF HOSPIRA INC, NUVO PHARMACEUTICALS INC.
Enquiry
Common questions
- Who makes diclofenac sodium?
- 48 companies list diclofenac sodium as a human prescription drug in the openFDA NDC Directory, led by International Medication Systems, Ltd., Proficient Rx LP, Bryant Ranch Prepack, NuCare Pharmaceuticals,Inc., ASCLEMED USA INC. DBA ENOVACHEM. 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 sodium?
- 48 companies list diclofenac sodium 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 sodium active ingredient?
- 19 companies list diclofenac sodium as a bulk ingredient, including Dipharma Francis Srl, MEDISCA Inc., Professional Compounding Centers of America dba PCCA, ASCLEMED USA INC. DBA ENOVACHEM.