Medicine
Sulfasalazine 500 mg delayed-release tablet
Sulfasalazine 500 mg delayed-release tablet is a generic prescription medicine for oral use, made by 2 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 25°C (77°F), excursions permitted to 15–30°C (59–86°F).
Key facts
- Active ingredient (INN)
- Sulfasalazine
- Brand
- Sold under the generic name
- Strength
- 500 mg
- Dosage form
- Delayed-release tablet
- Route
- Oral
- Packs
- 1 bottle, 100 tablets, 300 tablets and 1 more
- Manufacturers
- Mylan PharmaceuticalsSunrise Pharmaceutical
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15–30°C (59–86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A07EC01 Sulfasalazine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 5 May 2005
- Identifiers
- RxCUI 313142DailyMed set ID d596ac59-b643-4181-80ba-f2db1cc3459c, 257cee60-b68f-4c2b-b57d-8e4d73d17e09NDC 11534-201, 59762-0104Application ANDA075339, NDA007073
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 |
|---|---|---|---|
| 1 bottle in 1 carton / 100 tablet, delayed release in 1 bottle | 59762-0104-5 | Mylan Pharmaceuticals | 23 March 2020 |
| 1 bottle in 1 carton / 300 tablet, delayed release in 1 bottle | 59762-0104-6 | Mylan Pharmaceuticals | 6 April 2020 |
| 100 tablet, delayed release in 1 bottle | 11534-201-01 | Sunrise Pharmaceutical | 11 December 2025 |
| 300 tablet, delayed release in 1 bottle | 11534-201-07 | Sunrise Pharmaceutical | 11 December 2025 |
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 20 June 1950 | 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
Alternatives
Other makers and brands of Sulfasalazine 500 mg delayed-release tablet.
Other strengths and forms of Sulfasalazine
Clinical summary
Sulfasalazine is an aminosalicylate indicated to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis, b) for the prolongation of the remission period between acute attacks of ulcerative colitis, among other approved uses. MedsAcross supplies Sulfasalazine 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 SulfasalazineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Sulfasalazine prescribing information (Mylan Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Sulfasalazine 500 mg delayed-release tablet 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.