FDA Orange Book
Generic for Prexxartan
Prexxartan contains valsartan. 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 Prexxartan is valsartan. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Prexxartan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 4MG/ML | Marketed (Rx) | AB | 2 | AB |
NDA 209139, held by CARMEL BIOSCIENCES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic valsartan
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NOVITIUM PHARMA LLC | 214102 | AB (A-rated, therapeutically equivalent) | November 2, 2021 | 4MG/ML |
| RUBICON RESEARCH LTD | 216460 | AB (A-rated, therapeutically equivalent) | June 5, 2025 | 4MG/ML |
Prexxartan NDC codes
Questions
Is there a generic for Prexxartan?
Yes. The generic name for Prexxartan is valsartan. 2 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 Prexxartan?
The active ingredient in Prexxartan is valsartan, 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.