FDA Orange Book
Generic for Ozobax DS
Ozobax DS contains baclofen. 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 Ozobax DS is baclofen. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
Run it in Rivvi
Map Ozobax DS and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Ozobax DS products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 10MG/5ML | Marketed (Rx) | AA | 1 | AA |
NDA 208193, 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 baclofen
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| RUBICON RESEARCH LTD | 214445 | AA (A-rated, therapeutically equivalent) | June 3, 2025 | 10MG/5ML |
Ozobax DS NDC codes
Questions
Is there a generic for Ozobax DS?
Yes. The generic name for Ozobax DS is baclofen. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
What is the generic name for Ozobax DS?
The active ingredient in Ozobax DS is baclofen, 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.