FDA Orange Book
Generic for Mydriacyl
Mydriacyl contains tropicamide. 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 Mydriacyl is tropicamide. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
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Mydriacyl products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | 0.5% | Discontinued | None | 3 | AT |
| solution/drops, ophthalmic | 1% | Discontinued | None | 4 | AT |
NDA 012111, held by ALCON LABORATORIES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic tropicamide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BAUSCH AND LOMB INC | 040067 | AT (A-rated, therapeutically equivalent) | July 27, 1994 | 0.5% |
| BAUSCH AND LOMB INC | 040064 | AT (A-rated, therapeutically equivalent) | July 27, 1994 | 1% |
| EPIC PHARMA LLC | 040314 | AT (A-rated, therapeutically equivalent) | September 29, 2000 | 0.5% |
| RISING PHARMA HOLDINGS INC | 040315 | AT (A-rated, therapeutically equivalent) | September 29, 2000 | 1% |
| SOMERSET THERAPEUTICS LLC | 207524 | AT (A-rated, therapeutically equivalent) | December 12, 2019 | 1% |
| SANDOZ INC | 084305 | AT (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 0.5% |
| ALCON LABORATORIES INC | 084306 | AT (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 1% |
Questions
Is there a generic for Mydriacyl?
Yes. The generic name for Mydriacyl is tropicamide. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
What is the generic name for Mydriacyl?
The active ingredient in Mydriacyl is tropicamide, 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.