Prescription medicine
Balsalazide First approved as Colazal
Balsalazide (Colazal) is a prescription medicine with an FDA approval on record since 2000. FDA's NDC Directory lists it from 9 generic labelers, and pharmacies paid $0.344 per balsalazide disodium 750 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the balsalazide FDA label on DailyMed (effective September 9, 2026, Apotex Corp.); the NDA 20610 record on Drugs@FDA; every balsalazide label on DailyMed.
Highlights of the record
FDA label of September 9, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageBalsalazide disodium capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older.
Forms and strengths
- 750 mg
Capsule.
On the market
- Earliest approval on file
- July 18, 2000 Colazal, Valeant Pharms Intl; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first December 28, 2007; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 9 of which 9 under generic applications, 0 under brand applications, repackagers included
- Last listed patent
- February 24, 2027 Colazal capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.344 per capsule Balsalazide disodium 750 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 505 through July 30, 2026
What is balsalazide used for?
From the label: indications and usageBalsalazide disodium capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. Limitations of Use Safety and effectiveness of balsalazide beyond 8 weeks in pediatric patients 5 years to 17 years of age and 12 weeks in adults have not been established. Balsalazide is an aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. ( 1 ) Limitations of Use: Safety and effectiveness of balsalazide beyond 8 weeks in children (ages 5 to 17 years) and 12 weeks in adults have not been established.
Conditions named in the indications of balsalazide's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Aminosalicylate.
Source: FDA drug label (Balsalazide Disodium), Apotex Corp., effective September 9, 2026 (SPL set f12ffa32-d14b-e9d9-e957-2ef08b64e8b4), via openFDA; the full label on DailyMed
Is there a generic for balsalazide (Colazal)?
The FDA approved the first generic balsalazide on December 28, 2007. 6 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists balsalazide from 9 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 2 patents for Colazal capsules, the last expiring on February 24, 2027; a patent listed only for Giazo tablets runs to June 23, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2000 earliest approval on file
- 2007 first generic approved
- 2027 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for balsalazide (Colazal)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.344 per Balsalazide disodium 750 mg capsule, down 16% from $0.410 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Balsalazide disodium 750 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Balsalazide disodium 750 mg capsule | Generic | $0.344 per capsule | $10.33 | -16% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the balsalazide label say about other medicines?
The balsalazide label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Azathioprine | drug interactions | Nephrotoxic Agents including NSAIDs: Increased risk of nephrotoxicity; monitor for changes in renal function and mesalamine-related adverse reactions. ( 7.1 ) Azathioprine or 6-Mercaptopurine: |
| Mesalamine | warnings and precautions | Use of mesalamine may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection. |
| Sulfasalazine | warnings and precautions | Some patients have experienced a hypersensitivity reaction to sulfasalazine may have a similar reaction to balsalazide disodium capsules or to other compounds that contain or are converted to mesalamine. |
Source: FDA drug label (Balsalazide Disodium), Apotex Corp., effective September 9, 2026 (SPL set f12ffa32-d14b-e9d9-e957-2ef08b64e8b4), via openFDA; the full label on DailyMed
What do FAERS reports show for balsalazide?
The FDA Adverse Event Reporting System holds 505 reports that list balsalazide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 10 are coded as a death and 107 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as balsalazide?
4 other medicines are given the same way (oral) and in the same FDA class as balsalazide or labeled mainly for the same use (crohn's disease and ulcerative colitis), the same class first. Crohn's disease and ulcerative colitis lists all 29 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Mesalamine | Crohn's disease and ulcerative colitis | 27 labelers | $0.781 per tablet 1.2 g tablet | A presentation being discontinued |
| Sulfasalazine | Crohn's disease and ulcerative colitis | 5 labelers | $0.199 per tablet 500 mg tablet | No current entry |
| Olsalazine | Crohn's disease and ulcerative colitis | none listed | $15.70 per capsule 250 mg capsule | No current entry |
| Etrasimod arginine | Crohn's disease and ulcerative colitis | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as balsalazide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to balsalazide
- 4 medicines for the same use
- Other aminosalicylates
- the pharmacologic class, with prices and generics
- Balsalazide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other