FDA Orange Book
Generic for Ultracet
Ultracet contains tramadol and acetaminophen. 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 Ultracet is tramadol and acetaminophen. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Ultracet products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 325MG;37.5MG | Discontinued | None | 5 | AB |
NDA 021123, 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 and acetaminophen
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| RISING PHARMA HOLDING INC | 077858 | AB (A-rated, therapeutically equivalent) | September 26, 2008 | 325MG;37.5MG |
| AMNEAL PHARMACEUTICALS | 090485 | AB (A-rated, therapeutically equivalent) | December 9, 2009 | 325MG;37.5MG |
| ALKEM LABORATORIES LTD | 202076 | AB (A-rated, therapeutically equivalent) | March 30, 2012 | 325MG;37.5MG |
| ZYDUS PHARMACEUTICALS USA INC | 090460 | AB (A-rated, therapeutically equivalent) | September 6, 2012 | 325MG;37.5MG |
| AUROBINDO PHARMA LTD | 207152 | AB (A-rated, therapeutically equivalent) | March 22, 2017 | 325MG;37.5MG |
Questions
Is there a generic for Ultracet?
Yes. The generic name for Ultracet is tramadol and acetaminophen. 5 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 Ultracet?
The active ingredient in Ultracet is tramadol and acetaminophen, 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.