Active ingredient
Balsalazide
9 finished FDA listings contain Balsalazide as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- BALSALAZIDE DISODIUM
- Dosage forms
- Capsule
- Routes
- Oral
- Manufacturers / labelers
- 9
- Strengths listed
- 750 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 18747
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 077806 | HIKMA | 2007-12-28 | 3 |
| ANDA 077883 | APOTEX | 2007-12-28 | 3 |
| ANDA 217592 | ZYDUS LIFESCIENCES | 2023-06-08 | 2 |
| ANDA 219422 | CARNEGIE | 2025-04-03 | 1 |
Official labeling on DailyMed
- BALSALAZIDE DISODIUM CAPSULE [APOTEX CORP.] · version 15 · 2026-09-10
- BALSALAZIDE DISODIUM CAPSULE [AVPAK] · version 10 · 2025-12-31
- BALSALAZIDE DISODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.] · version 16 · 2025-11-17
- BALSALAZIDE DISODIUM CAPSULE [CARNEGIE PHARMACEUTICALS, LLC] · version 1 · 2025-07-01
- BALSALAZIDE DISODIUM CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.] · version 4 · 2025-06-16
- BALSALAZIDE DISODIUM CAPSULE [ZYDUS LIFESCIENCES LIMITED] · version 3 · 2025-06-16
- BALSALAZIDE DISODIUM CAPSULE [BRYANT RANCH PREPACK] · version 102 · 2025-04-07
- BALSALAZIDE DISODIUM CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 4 · 2025-02-21
- BALSALAZIDE DISODIUM CAPSULE [HIKMA PHARMACEUTICALS USA INC.] · version 12 · 2024-05-07
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.