FDA Orange Book
Generic for Opana
Opana contains oxymorphone. 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 Opana is oxymorphone. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 4 Opana products the Orange Book lists.
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Opana products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 1.5MG/ML | Discontinued | None | 0 | None |
| injectable, injection | 1MG/ML | Discontinued | None | 0 | None |
| tablet, oral | 10MG | Discontinued | None | 6 | AB |
| tablet, oral | 5MG | Discontinued | None | 6 | AB |
NDA 011707, 021611, held by ENDO PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic oxymorphone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 090964 | AB (A-rated, therapeutically equivalent) | September 27, 2010 | 10MG, 5MG |
| TEVA PHARMACEUTICALS USA INC | 091443 | AB (A-rated, therapeutically equivalent) | February 15, 2011 | 10MG, 5MG |
| AVANTHI INC | 203601 | AB (A-rated, therapeutically equivalent) | January 30, 2013 | 10MG, 5MG |
| EPIC PHARMA LLC | 201187 | AB (A-rated, therapeutically equivalent) | December 15, 2014 | 10MG, 5MG |
| AUROLIFE PHARMA LLC | 204459 | AB (A-rated, therapeutically equivalent) | April 26, 2016 | 10MG, 5MG |
| ASCENT PHARMACEUTICALS INC | 210175 | AB (A-rated, therapeutically equivalent) | February 2, 2018 | 10MG, 5MG |
Questions
Is there a generic for Opana?
Yes. The generic name for Opana is oxymorphone. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 4 Opana products the Orange Book lists.
What is the generic name for Opana?
The active ingredient in Opana is oxymorphone, 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.