FDA Orange Book
Generic for Mucomyst
Mucomyst contains acetylcysteine. 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 Mucomyst is acetylcysteine. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AN.
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Mucomyst products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, inhalation, oral | 10% | Discontinued | None | 5 | AN |
| solution, inhalation, oral | 20% | Discontinued | None | 5 | AN |
NDA 013601, held by APOTHECON INC DIV BRISTOL MYERS SQUIBB. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic acetylcysteine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HOSPIRA INC | 073664 | AN (A-rated, therapeutically equivalent) | August 30, 1994 | 10% |
| HOSPIRA INC | 074037 | AN (A-rated, therapeutically equivalent) | August 30, 1994 | 20% |
| AMERICAN REGENT INC | 072489 | AN (A-rated, therapeutically equivalent) | July 28, 1995 | 10% |
| AMERICAN REGENT INC | 072547 | AN (A-rated, therapeutically equivalent) | July 28, 1995 | 20% |
| ALVOGEN INC | 203853 | AN (A-rated, therapeutically equivalent) | June 21, 2012 | 20% |
| ALVOGEN INC | 204674 | AN (A-rated, therapeutically equivalent) | February 11, 2014 | 10% |
| SOMERSET THERAPEUTICS LLC | 219194 | AN (A-rated, therapeutically equivalent) | February 12, 2025 | 10%, 20% |
| CONBA USA INC | 214177 | AN (A-rated, therapeutically equivalent) | March 14, 2025 | 10%, 20% |
Questions
Is there a generic for Mucomyst?
Yes. The generic name for Mucomyst is acetylcysteine. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AN.
What is the generic name for Mucomyst?
The active ingredient in Mucomyst is acetylcysteine, 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.