Medicine
Balsalazide 750 mg capsule
Balsalazide 750 mg capsule is a generic prescription medicine for oral use, made by 8 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C…
Key facts
- Active ingredient (INN)
- Balsalazide
- Brand
- Sold under the generic name
- Strength
- 750 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 280 capsules, 10 blister pack, 30 capsules and 9 more
- Manufacturers
- Zydus LifesciencesIndiaApotexAvPAKBryant Ranch PrepackCarnegie PharmaceuticalsGolden State Medical SupplyHikma PharmaceuticalsPD-Rx Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (59° and 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A07EC04 Balsalazide
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 28 December 2007
- Identifiers
- RxCUI 885857DailyMed set ID 0ed73067-e2ca-4184-a93a-5a2141bb4898, f12ffa32-d14b-e9d9-e957-2ef08b64e8b4, cd73c9f1-d83b-4206-b2c6-1bd111e11263 +6NDC 70710-1626, 60505-2575, 72162-2095 +6Application ANDA217592, ANDA077883, ANDA077806 +1
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 280 capsule in 1 bottle | 70710-1626-1 | Zydus LifesciencesIndia | 25 August 2023 |
| 280 capsule in 1 bottle | 70771-1841-1 | Zydus LifesciencesIndia | 25 August 2023 |
| 10 blister pack in 1 carton / 10 capsule in 1 blister pack | 60505-2575-0 | Apotex | 28 December 2007 |
| 30 capsule in 1 bottle | 60505-2575-3 | Apotex | 28 December 2007 |
| 350 capsule in 1 bottle | 60505-2575-4 | Apotex | 28 December 2007 |
| 280 capsule in 1 bottle | 60505-2575-7 | Apotex | 28 December 2007 |
| 280 capsule in 1 bottle | 80005-126-25 | Carnegie Pharmaceuticals | 30 June 2025 |
| 280 capsule in 1 bottle | 0054-0079-28 | Hikma Pharmaceuticals | 28 December 2007 |
| 30 blister pack in 1 box / 1 capsule in 1 blister pack | 50268-102-13 | AvPAK | 6 November 2014 |
| 280 capsule in 1 bottle | 72162-2095-2 | Bryant Ranch Prepack | 28 December 2007 |
| 280 capsule in 1 bottle | 51407-820-28 | Golden State Medical Supply | 14 July 2023 |
| 280 capsule in 1 bottle, plastic | 72789-149-69 | PD-Rx Pharmaceuticals | 2 December 2020 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 18 July 2000 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
Balsalazide is an aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. It is available as capsules for oral use. MedsAcross supplies Balsalazide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about BalsalazideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- balsalazide disodium prescribing information (Zydus Lifesciences) · U.S. National Library of Medicine, DailyMed
Need Balsalazide 750 mg capsule for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.