FDA Orange Book
Generic for Valstar Preservative Free
Valstar Preservative Free contains valrubicin. 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 Valstar Preservative Free is valrubicin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AO.
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Valstar Preservative Free products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravesical | 40MG/ML | Marketed (Rx) | AO | 1 | AO |
NDA 020892, held by ENDO OPERATIONS LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic valrubicin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 206430 | AO (A-rated, therapeutically equivalent) | April 19, 2019 | 40MG/ML |
Valstar Preservative Free NDC codes
Questions
Is there a generic for Valstar Preservative Free?
Yes. The generic name for Valstar Preservative Free is valrubicin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AO.
What is the generic name for Valstar Preservative Free?
The active ingredient in Valstar Preservative Free is valrubicin, 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.