FDA Orange Book
Generic for Qdolo
Qdolo 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 Qdolo is tramadol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
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Qdolo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 5MG/ML | Discontinued | None | 1 | None |
NDA 214044, held by ROSEMOUNT PHARMACEUTICALS 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 |
|---|---|---|---|---|
| NOVITIUM PHARMA LLC | 219647 | None (No TE code listed) | June 26, 2026 | 5MG/ML |
Qdolo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11103452 | September 1, 2040 | Drug product | U-3197 | 214044 |
| 11752103 | September 1, 2040 | Drug product | U-3197 | 214044 |
Qdolo NDC codes
Questions
Is there a generic for Qdolo?
Yes. The generic name for Qdolo is tramadol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
What is the generic name for Qdolo?
The active ingredient in Qdolo is tramadol, per the FDA Orange Book.
When does the Qdolo patent expire?
The last patent listed for Qdolo in the Orange Book expires September 1, 2040. A listed patent expiry date is not a generic launch date.
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.