Active ingredient
Pentoxifylline
7 finished FDA listings contain Pentoxifylline as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- PENTOXIFYLLINE
- Dosage forms
- Tablet, Extended Release
- Routes
- Oral
- Manufacturers / labelers
- 6
- Strengths listed
- 400 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 8013
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 074425 | RISING | 1997-07-08 | 2 |
| ANDA 074878 | ANI PHARMS | 1997-07-09 | 2 |
| ANDA 075191 | APOTEX | 1999-06-09 | 3 |
Official labeling on DailyMed
- PENTOXIFYLLINE TABLET, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.] · version 4 · 2026-06-30
- PENTOXIFYLLINE TABLET, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.] · version 3 · 2025-11-17
- PENTOXIFYLLINE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] · version 6 · 2025-10-01
- PENTOXIFYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] · version 1012 · 2025-09-08
- PENTOXIFYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] · version 1 · 2025-04-10
- PENTOXIFYLLINE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] · version 2 · 2024-10-24
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.