FDA Orange Book
Generic for Bloxiverz
Bloxiverz contains neostigmine methylsulfate. 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 Bloxiverz is neostigmine methylsulfate. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 3 Bloxiverz products the Orange Book lists.
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Bloxiverz products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 10MG/10ML (1MG/ML) | Discontinued | None | 13 | AP |
| solution, intravenous | 5MG/10ML (0.5MG/ML) | Discontinued | None | 13 | AP |
| solution, intravenous | 5MG/5ML (1MG/ML) | Discontinued | None | 0 | None |
NDA 204078, held by EXELA PHARMA SCIENCES LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic neostigmine methylsulfate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 207042 | AP (A-rated, therapeutically equivalent) | December 28, 2015 | 10MG/10ML (1MG/ML), 5MG/10ML (0.5MG/ML) |
| PH HEALTH LTD | 208405 | AP (A-rated, therapeutically equivalent) | April 26, 2017 | 10MG/10ML (1MG/ML), 5MG/10ML (0.5MG/ML) |
| AMPHASTAR PHARMACEUTICALS INC | 209933 | AP (A-rated, therapeutically equivalent) | September 25, 2017 | 10MG/10ML (1MG/ML), 5MG/10ML (0.5MG/ML) |
| DR REDDYS LABORATORIES LTD | 209135 | AP (A-rated, therapeutically equivalent) | July 10, 2018 | 10MG/10ML (1MG/ML), 5MG/10ML (0.5MG/ML) |
| J MOLNER HOLDINGS INC | 210989 | AP (A-rated, therapeutically equivalent) | August 22, 2018 | 10MG/10ML (1MG/ML), 5MG/10ML (0.5MG/ML) |
| BE PHARMACEUTICALS AG | 212512 | AP (A-rated, therapeutically equivalent) | May 13, 2019 | 10MG/10ML (1MG/ML), 5MG/10ML (0.5MG/ML) |
| GLAND PHARMA LTD | 212968 | AP (A-rated, therapeutically equivalent) | October 16, 2019 | 10MG/10ML (1MG/ML), 5MG/10ML (0.5MG/ML) |
| MEITHEAL PHARMACEUTICALS INC | 212804 | AP (A-rated, therapeutically equivalent) | April 5, 2021 | 10MG/10ML (1MG/ML), 5MG/10ML (0.5MG/ML) |
| CAPLIN STERILES LTD | 213074 | AP (A-rated, therapeutically equivalent) | April 20, 2021 | 10MG/10ML (1MG/ML), 5MG/10ML (0.5MG/ML) |
| REGCON HOLDINGS LLC | 210652 | AP (A-rated, therapeutically equivalent) | October 1, 2021 | 10MG/10ML (1MG/ML), 5MG/10ML (0.5MG/ML) |
| NIVAGEN PHARMACEUTICALS LLC | 212627 | AP (A-rated, therapeutically equivalent) | November 3, 2022 | 10MG/10ML (1MG/ML), 5MG/10ML (0.5MG/ML) |
| AVET LIFESCIENCES PRIVATE LTD | 208230 | AP (A-rated, therapeutically equivalent) | November 25, 2022 | 10MG/10ML (1MG/ML), 5MG/10ML (0.5MG/ML) |
| SAGENT PHARMACEUTICALS INC | 216542 | AP (A-rated, therapeutically equivalent) | February 17, 2023 | 10MG/10ML (1MG/ML), 5MG/10ML (0.5MG/ML) |
Bloxiverz NDC codes
Questions
Is there a generic for Bloxiverz?
Yes. The generic name for Bloxiverz is neostigmine methylsulfate. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 3 Bloxiverz products the Orange Book lists.
What is the generic name for Bloxiverz?
The active ingredient in Bloxiverz is neostigmine methylsulfate, 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.