Drug
Who makes sulfasalazine?
11 companies list sulfasalazine as a human prescription drug, including under the names Azulfidine, Azulfidine EN-tabs. Forms: tablet; tablet, delayed release. 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 sulfasalazine
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| International Medication Systems, Ltd.United States | tablet | NDA AUTHORIZED GENERICNDA007073 | 2 | 3 |
| Sunrise Pharmaceutical IncUnited States | tablet; tablet, delayed release | ANDAANDA040349, ANDA075339 | 2 | 1 |
| Mylan Pharmaceuticals, Inc. | tablet; tablet, delayed release | NDA AUTHORIZED GENERICNDA007073 | 2 | 0 |
| Pfizer Laboratories Div Pfizer Inc | tablet; tablet, delayed release | NDANDA007073 | 2 | 0 |
| Teva Pharmaceutical Industries Ltd.Canada | tablet | ANDAANDA085828 | 1 | 6 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet | ANDAANDA085828 | 1 | 5 |
| Bryant Ranch PrepackUnited States | tablet | ANDAANDA085828 | 1 | 1 |
| RemedyRepack, IncUnited States | tablet | NDA AUTHORIZED GENERICNDA007073 | 1 | 1 |
| Rising Pharma Holdings, Inc.United States | tablet | ANDAANDA219046 | 1 | 1 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet | NDA AUTHORIZED GENERICNDA007073 | 1 | 0 |
| Chartwell RX, LLC. | tablet | ANDAANDA080197 | 1 | 0 |
Bulk ingredient listings
- Cambrex Charles City, Inc. · 4 NDC
- Cohance Lifesciences LimitedIndia · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
- Valens Molecules Private LimitedIndia · 1 NDC
Enquiry
Common questions
- Who makes sulfasalazine?
- 11 companies list sulfasalazine as a human prescription drug in the openFDA NDC Directory, led by International Medication Systems, Ltd., Sunrise Pharmaceutical Inc, Mylan Pharmaceuticals, Inc., Pfizer Laboratories Div Pfizer Inc, Teva Pharmaceutical Industries Ltd.. 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 Azulfidine?
- 6 companies list sulfasalazine 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 sulfasalazine active ingredient?
- 6 companies list sulfasalazine as a bulk ingredient, including Cambrex Charles City, Inc., Cohance Lifesciences Limited, LETCO MEDICAL, LLC, MEDISCA Inc..