Medicine
Diflunisal 500 mg tablet
Diflunisal 500 mg tablet is a generic prescription medicine for oral use, made by 4 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).
Key facts
- Active ingredient (INN)
- Diflunisal
- Brand
- Sold under the generic name
- Strength
- 500 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 30 tablets and 18 more
- Manufacturers
- Zydus LifesciencesIndiaAvet PharmaceuticalsIndiaTeva PharmaceuticalsChartwell RX
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N02BA11 Diflunisal
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 8 March 2012
- Identifiers
- RxCUI 197603, 197602, 249400DailyMed set ID 5baf9f35-6b5e-4666-a14a-ac0f9d4e9f76, 2043bab8-87c9-45ce-88c7-383f0d4c4b64, 7a78bb38-14d8-4a90-b883-482d4cebf716 +2NDC 68382-530, 62135-456, 0093-9222 +2Application ANDA203547, ANDA202845, ANDA073673
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 |
|---|---|---|---|
| 100 tablet in 1 bottle | 68382-530-01 | Zydus LifesciencesIndia | 14 September 2017 |
| 500 tablet in 1 bottle | 68382-530-05 | Zydus LifesciencesIndia | 14 September 2017 |
| 30 tablet in 1 bottle | 68382-530-06 | Zydus LifesciencesIndia | 14 September 2017 |
| 1000 tablet in 1 bottle | 68382-530-10 | Zydus LifesciencesIndia | 14 September 2017 |
| 60 tablet in 1 bottle | 68382-530-14 | Zydus LifesciencesIndia | 14 September 2017 |
| 90 tablet in 1 bottle | 68382-530-16 | Zydus LifesciencesIndia | 14 September 2017 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 68382-530-30 | Zydus LifesciencesIndia | 14 September 2017 |
| 1000 tablet in 1 bottle | 70771-1083-0 | Zydus LifesciencesIndia | 14 September 2017 |
| 100 tablet in 1 bottle | 70771-1083-1 | Zydus LifesciencesIndia | 14 September 2017 |
| 30 tablet in 1 bottle | 70771-1083-3 | Zydus LifesciencesIndia | 14 September 2017 |
| 500 tablet in 1 bottle | 70771-1083-5 | Zydus LifesciencesIndia | 14 September 2017 |
| 60 tablet in 1 bottle | 70771-1083-6 | Zydus LifesciencesIndia | 14 September 2017 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 70771-1083-8 | Zydus LifesciencesIndia | 14 September 2017 |
| 90 tablet in 1 bottle | 70771-1083-9 | Zydus LifesciencesIndia | 14 September 2017 |
| 100 tablet, film coated in 1 bottle | 14539-673-01 | Avet PharmaceuticalsIndia | 9 January 2019 |
| 500 tablet, film coated in 1 bottle | 14539-673-05 | Avet PharmaceuticalsIndia | 9 January 2019 |
| 60 tablet, film coated in 1 bottle | 14539-673-06 | Avet PharmaceuticalsIndia | 9 January 2019 |
| 60 tablet, film coated in 1 bottle | 62135-456-60 | Chartwell RX | 31 January 2023 |
| 100 tablet, film coated in 1 bottle | 0093-9222-01 | Teva Pharmaceuticals | 30 June 2021 |
| 500 tablet, film coated in 1 bottle | 0093-9222-05 | Teva Pharmaceuticals | 25 August 2022 |
| 60 tablet, film coated in 1 bottle | 0093-9222-06 | Teva Pharmaceuticals | 30 June 2021 |
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.
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
Other strengths and forms of Diflunisal
Clinical summary
Diflunisal is a nonsteroidal anti-inflammatory drug indicated for acute or long-term use for symptomatic treatment of the following. It is available as tablets for oral use. MedsAcross supplies Diflunisal 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 DiflunisalFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- diflunisal prescribing information (Avet Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Attrogy: European public assessment report (EPAR) · European Medicines Agency
Need Diflunisal 500 mg tablet for your hospital or patient?
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