FDA Orange Book
Generic for Exalgo
Exalgo contains hydromorphone. 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 Exalgo is hydromorphone. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Exalgo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 12MG | Discontinued | None | 3 | AB |
| tablet, extended release, oral | 16MG | Discontinued | None | 3 | AB |
| tablet, extended release, oral | 32MG | Discontinued | None | 3 | AB |
| tablet, extended release, oral | 8MG | Discontinued | None | 3 | AB |
NDA 021217, held by SPECGX LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic hydromorphone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PADAGIS US LLC | 204278 | AB (A-rated, therapeutically equivalent) | April 6, 2015 | 12MG, 16MG, 32MG, 8MG |
| OSMOTICA PHARMACEUTICAL US LLC | 205629 | AB (A-rated, therapeutically equivalent) | July 7, 2016 | 12MG, 16MG, 32MG, 8MG |
| ASCENT PHARMACEUTICALS INC | 212133 | AB (A-rated, therapeutically equivalent) | September 23, 2020 | 12MG, 16MG, 32MG, 8MG |
Questions
Is there a generic for Exalgo?
Yes. The generic name for Exalgo is hydromorphone. 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 Exalgo?
The active ingredient in Exalgo is hydromorphone, 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.