FDA Orange Book
Generic for Trental
Trental contains pentoxifylline. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Trental is pentoxifylline. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Trental products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 400MG | Marketed (Rx) | AB | 3 | AB |
NDA 018631, held by VALIDUS PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic pentoxifylline
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| RISING PHARMA HOLDING INC | 074425 | AB (A-rated, therapeutically equivalent) | July 8, 1997 | 400MG |
| ANI PHARMACEUTICALS INC | 074878 | AB (A-rated, therapeutically equivalent) | July 9, 1997 | 400MG |
| APOTEX INC | 075191 | AB (A-rated, therapeutically equivalent) | June 9, 1999 | 400MG |
Trental NDC codes
Questions
Is there a generic for Trental?
Yes. The generic name for Trental is pentoxifylline. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Trental?
The active ingredient in Trental is pentoxifylline, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.