FDA Orange Book
Generic for Ryzolt
Ryzolt 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 Ryzolt 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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Ryzolt 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 021745, held by PURDUE PHARMA PRODUCTS LP. 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 Ryzolt?
Yes. The generic name for Ryzolt 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 Ryzolt?
The active ingredient in Ryzolt 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.