FDA Orange Book
Generic for Ultram
Ultram 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 is tramadol. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Ultram products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Discontinued | None | 2 | AB |
| tablet, oral | 50MG | Discontinued | None | 10 | AB |
NDA 020281, held by JANSSEN PHARMACEUTICALS INC. 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 |
|---|---|---|---|---|
| SUN PHARMACEUTICAL INDUSTRIES INC | 075964 | AB (A-rated, therapeutically equivalent) | June 19, 2002 | 50MG |
| TEVA PHARMACEUTICALS USA INC | 075977 | AB (A-rated, therapeutically equivalent) | June 19, 2002 | 50MG |
| AMNEAL PHARMACEUTICALS OF NEW YORK LLC | 076003 | AB (A-rated, therapeutically equivalent) | June 20, 2002 | 50MG |
| PHARMAZONE | 090404 | AB (A-rated, therapeutically equivalent) | January 31, 2011 | 50MG |
| STRIDES PHARMA GLOBAL PTE LTD | 202075 | AB (A-rated, therapeutically equivalent) | November 28, 2011 | 50MG |
| CSPC OUYI PHARMACEUTICAL CO LTD | 091498 | AB (A-rated, therapeutically equivalent) | March 29, 2013 | 50MG |
| AUROBINDO PHARMA LTD | 203494 | AB (A-rated, therapeutically equivalent) | March 31, 2014 | 50MG |
| RUBICON RESEARCH LTD | 208708 | AB (A-rated, therapeutically equivalent) | June 28, 2019 | 100MG, 50MG |
| UNICHEM LABORATORIES LTD | 211825 | AB (A-rated, therapeutically equivalent) | August 9, 2019 | 50MG |
| GRAVITI PHARMACEUTICALS PRIVATE LTD | 075968 | AB (A-rated, therapeutically equivalent) | August 2, 2024 | 100MG, 50MG |
Questions
Is there a generic for Ultram?
Yes. The generic name for Ultram is tramadol. 10 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 Ultram?
The active ingredient in Ultram 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.