FDA Orange Book
Generic for Bicnu
Bicnu contains carmustine. 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 Bicnu is carmustine. 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 Bicnu 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.
Bicnu products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 100MG/VIAL | Marketed (Rx) | AP | 7 | AP |
NDA 017422, held by AVET LIFESCIENCES LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic carmustine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NAVINTA LLC | 210179 | AP (A-rated, therapeutically equivalent) | September 11, 2018 | 100MG/VIAL |
| AMNEAL EU LTD | 211229 | AP (A-rated, therapeutically equivalent) | October 16, 2018 | 100MG/VIAL |
| PENN LIFE SCIENCES LLC | 209278 | AP (A-rated, therapeutically equivalent) | April 2, 2019 | 100MG/VIAL |
| DR REDDYS LABORATORIES LTD | 213207 | AP (A-rated, therapeutically equivalent) | October 22, 2020 | 100MG/VIAL |
| MEITHEAL PHARMACEUTICALS INC | 213460 | AP (A-rated, therapeutically equivalent) | August 2, 2021 | 100MG/VIAL |
| MSN LABORATORIES PRIVATE LTD | 214814 | AP (A-rated, therapeutically equivalent) | May 11, 2023 | 100MG/VIAL |
| ALEMBIC PHARMACEUTICALS LTD | 215730 | AP (A-rated, therapeutically equivalent) | October 20, 2023 | 100MG/VIAL |
Questions
Is there a generic for Bicnu?
Yes. The generic name for Bicnu is carmustine. 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 Bicnu?
The active ingredient in Bicnu is carmustine, 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.