FDA Orange Book
Generic for Mestinon
Mestinon contains pyridostigmine bromide. 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 Mestinon is pyridostigmine bromide. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB. Generics match 3 of the 4 Mestinon products the Orange Book lists.
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Mestinon products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 5MG/ML | Marketed (Rx) | AP | 0 | None |
| syrup, oral | 60MG/5ML | Marketed (Rx) | AA | 5 | AA |
| tablet, extended release, oral | 180MG | Marketed (Rx) | AB | 2 | AB |
| tablet, oral | 60MG | Marketed (Rx) | AB | 4 | AB |
NDA 009830, 015193, 011665, 009829, held by BAUSCH HEALTH US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic pyridostigmine bromide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| IMPAX LABORATORIES INC | 040502 | AB (A-rated, therapeutically equivalent) | April 24, 2003 | 60MG |
| ANI PHARMACEUTICALS INC | 040512 | AB (A-rated, therapeutically equivalent) | October 8, 2003 | 60MG |
| ZYDUS PHARMACEUTICALS USA INC | 205650 | AB (A-rated, therapeutically equivalent) | June 22, 2015 | 60MG |
| ALVOGEN INC | 204737 | AB (A-rated, therapeutically equivalent) | June 26, 2015 | 180MG |
| RISING PHARMA HOLDINGS INC | 205464 | AB (A-rated, therapeutically equivalent) | August 15, 2017 | 180MG |
| MLV PHARMA LLC | 211181 | AB (A-rated, therapeutically equivalent) | July 20, 2018 | 60MG |
| NOVITIUM PHARMA LLC | 211694 | AA (A-rated, therapeutically equivalent) | March 8, 2019 | 60MG/5ML |
| RISING PHARMA HOLDING INC | 208797 | AA (A-rated, therapeutically equivalent) | January 9, 2020 | 60MG/5ML |
| AMNEAL PHARMACEUTICALS LLC | 212702 | AA (A-rated, therapeutically equivalent) | January 10, 2020 | 60MG/5ML |
| MILLA PHARMACEUTICALS INC | 212405 | AA (A-rated, therapeutically equivalent) | April 19, 2022 | 60MG/5ML |
| MSN LABORATORIES PRIVATE LTD | 216512 | AA (A-rated, therapeutically equivalent) | September 21, 2023 | 60MG/5ML |
Mestinon NDC codes
Questions
Is there a generic for Mestinon?
Yes. The generic name for Mestinon is pyridostigmine bromide. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB. Generics match 3 of the 4 Mestinon products the Orange Book lists.
What is the generic name for Mestinon?
The active ingredient in Mestinon is pyridostigmine bromide, 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.