FDA Orange Book
Generic for Ultram ER
Ultram ER contains tramadol. 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 Ultram ER is tramadol. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1.
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Ultram ER products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 100MG | Discontinued | None | 2 | AB1 |
| tablet, extended release, oral | 200MG | Discontinued | None | 2 | AB1 |
| tablet, extended release, oral | 300MG | Discontinued | None | 2 | AB1 |
NDA 021692, held by VALEANT PHARMACEUTICALS NORTH AMERICA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic tramadol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| LUPIN LTD | 200503 | AB1 (A-rated, therapeutically equivalent) | August 29, 2011 | 100MG, 200MG, 300MG |
| MACLEODS PHARMACEUTICALS LTD | 209404 | AB1 (A-rated, therapeutically equivalent) | January 31, 2025 | 100MG, 200MG, 300MG |
Questions
Is there a generic for Ultram ER?
Yes. The generic name for Ultram ER is tramadol. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1.
What is the generic name for Ultram ER?
The active ingredient in Ultram ER is tramadol, 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.