Medicine
Pentoxifylline 400 mg extended-release tablet
Pentoxifylline 400 mg extended-release tablet is a generic prescription medicine for oral use, made by 6 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). Protect from light.
Key facts
- Active ingredient (INN)
- Pentoxifylline
- Brand
- Sold under the generic name
- Strength
- 400 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 50 blister pack and 14 more
- Manufacturers
- Bryant Ranch PrepackRising Pharma HoldingsANI PharmaceuticalsApotexMajor PharmaceuticalsVangard Labs
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C04AD03 Pentoxifylline
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 10 June 1999
- Identifiers
- RxCUI 312301DailyMed set ID c3ad4fb4-8995-46ab-86e9-7ec67ef607f9, bd2f2672-62cd-4e77-8b0b-782f5d06198b, 59c9a583-1f93-480f-879c-457a574374da +4NDC 71335-2586, 0615-8511, 0904-5448 +4Application ANDA074425, ANDA074878, ANDA075191
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, extended release in 1 bottle | 70954-668-10 | ANI Pharmaceuticals | 15 January 2024 |
| 500 tablet, extended release in 1 bottle | 70954-668-20 | ANI Pharmaceuticals | 15 January 2024 |
| 100 tablet, extended release in 1 bottle | 60505-0033-6 | Apotex | 10 June 1999 |
| 500 tablet, extended release in 1 bottle | 60505-0033-7 | Apotex | 10 June 1999 |
| 100 tablet, extended release in 1 bottle | 16571-856-01 | Rising Pharma Holdings | 5 June 2026 |
| 50 blister pack in 1 carton / 10 tablet, extended release in 1 blister pack | 16571-856-05 | Rising Pharma Holdings | 5 June 2026 |
| 10 blister pack in 1 carton / 10 tablet, extended release in 1 blister pack | 16571-856-11 | Rising Pharma Holdings | 5 June 2026 |
| 500 tablet, extended release in 1 bottle | 16571-856-50 | Rising Pharma Holdings | 5 June 2026 |
| 1 blister pack in 1 carton / 10 tablet, extended release in 1 blister pack | 16571-856-90 | Rising Pharma Holdings | 5 June 2026 |
| 30 tablet, extended release in 1 bottle | 63629-2910-1 | Bryant Ranch Prepack | 9 August 2005 |
| 60 tablet, extended release in 1 bottle | 63629-2910-2 | Bryant Ranch Prepack | 6 December 2024 |
| 90 tablet, extended release in 1 bottle | 63629-2910-3 | Bryant Ranch Prepack | 11 October 2023 |
| 30 tablet, extended release in 1 bottle | 71335-2586-1 | Bryant Ranch Prepack | 7 April 2025 |
| 60 tablet, extended release in 1 bottle | 71335-2586-2 | Bryant Ranch Prepack | 7 April 2025 |
| 90 tablet, extended release in 1 bottle | 71335-2586-3 | Bryant Ranch Prepack | 7 April 2025 |
| 100 blister pack in 1 carton / 1 tablet, extended release in 1 blister pack | 0904-5448-61 | Major Pharmaceuticals | 10 June 1999 |
| 30 tablet, extended release in 1 blister pack | 0615-8511-39 | Vangard Labs | 26 June 2024 |
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 30 August 1984 | 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 Pentoxifylline 400 mg extended-release tablet.
Other strengths and forms of Pentoxifylline
Clinical summary
Pentoxifylline is a blood viscosity reducer indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. It is available as extended-release tablets and tablets for oral use. MedsAcross supplies Pentoxifylline 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 PentoxifyllineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Pentoxifylline prescribing information (Advagen Pharma) · U.S. National Library of Medicine, DailyMed
Need Pentoxifylline 400 mg extended-release tablet for your hospital or patient?
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