FDA Orange Book
Generic for Provayblue
Provayblue contains methylene blue. 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 Provayblue is methylene blue. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
Run it in Rivvi
Map Provayblue 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.
Provayblue products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 10MG/2ML (5MG/ML) | Marketed (Rx) | AP | 1 | AP |
| solution, intravenous | 50MG/10ML (5MG/ML) | Marketed (Rx) | AP | 7 | AP |
NDA 204630, held by PROVEPHARM SAS. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic methylene blue
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ZYDUS LIFESCIENCES GLOBAL FZE | 215636 | AP (A-rated, therapeutically equivalent) | December 5, 2023 | 10MG/2ML (5MG/ML), 50MG/10ML (5MG/ML) |
| NEXUS PHARMACEUTICALS LLC | 217561 | AP (A-rated, therapeutically equivalent) | November 21, 2024 | 50MG/10ML (5MG/ML) |
| STERISCIENCE PTE LTD | 216955 | AP (A-rated, therapeutically equivalent) | November 22, 2024 | 50MG/10ML (5MG/ML) |
| HIKMA PHARMACEUTICALS USA INC | 216959 | AP (A-rated, therapeutically equivalent) | December 17, 2024 | 50MG/10ML (5MG/ML) |
| MEITHEAL PHARMACEUTICALS INC | 217380 | AP (A-rated, therapeutically equivalent) | January 23, 2025 | 50MG/10ML (5MG/ML) |
| XIROMED PHARMA ESPANA SL | 219363 | AP (A-rated, therapeutically equivalent) | July 30, 2025 | 50MG/10ML (5MG/ML) |
| CHENGDU SHUODE PHARMACEUTICAL CO LTD | 219550 | AP (A-rated, therapeutically equivalent) | December 23, 2025 | 50MG/10ML (5MG/ML) |
Provayblue exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-303 | Miscellaneous | January 8, 2027 | 204630 |
Provayblue NDC codes
Questions
Is there a generic for Provayblue?
Yes. The generic name for Provayblue is methylene blue. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Provayblue?
The active ingredient in Provayblue is methylene blue, 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.