Drug
Who makes balsalazide disodium?
9 companies list balsalazide disodium as a human prescription drug. Forms: capsule. 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 balsalazide disodium
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Zydus Lifesciences LimitedIndia | capsule | ANDAANDA217592 | 1 | 12 |
| Apotex Inc.Canada | capsule | ANDAANDA077883 | 1 | 6 |
| Hikma Pharmaceuticals USA Inc.United States | capsule | ANDAANDA077806 | 1 | 4 |
| Bryant Ranch PrepackUnited States | capsule | ANDAANDA077883 | 1 | 1 |
| Carnegie Pharmaceuticals, LLCUnited States | capsule | ANDAANDA219422 | 1 | 1 |
| Golden State Medical Supply Inc.United States | capsule | ANDAANDA077806 | 1 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | capsule | ANDAANDA077806 | 1 | 1 |
| Zydus Pharmaceuticals USA Inc.India | capsule | ANDAANDA217592 | 1 | 1 |
| AvPAK | capsule | ANDAANDA077883 | 1 | 0 |
Bulk ingredient listings
- Pharmazell (India) Private LimitedIndia · 7 NDC
Orange Book patents
3 unexpired patents list balsalazide disodium as the active ingredient, expiring between Feb 2027 and Jun 2031. Application holder: VALEANT PHARMACEUTICALS INTERNATIONAL.
Enquiry
Common questions
- Who makes balsalazide disodium?
- 9 companies list balsalazide disodium as a human prescription drug in the openFDA NDC Directory, led by Zydus Lifesciences Limited, Apotex Inc., Hikma Pharmaceuticals USA Inc., Bryant Ranch Prepack, Carnegie Pharmaceuticals, 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 balsalazide disodium?
- 9 companies list balsalazide disodium 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 balsalazide disodium active ingredient?
- 1 company lists balsalazide disodium as a bulk ingredient, including Pharmazell (India) Private Limited.