FDA Orange Book
Generic for Ophthaine
Ophthaine contains proparacaine. 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 Ophthaine is proparacaine. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
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Ophthaine 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 | 6 | AT |
NDA 008883, 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 proparacaine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BAUSCH AND LOMB INC | 040074 | AT (A-rated, therapeutically equivalent) | September 29, 1995 | 0.5% |
| RISING PHARMA HOLDINGS INC | 040277 | AT (A-rated, therapeutically equivalent) | March 16, 2000 | 0.5% |
| SOMERSET THERAPEUTICS LLC | 215816 | AT (A-rated, therapeutically equivalent) | August 9, 2024 | 0.5% |
| MANKIND PHARMA LTD | 219136 | AT (A-rated, therapeutically equivalent) | May 21, 2025 | 0.5% |
| MICRO LABS LTD | 219294 | AT (A-rated, therapeutically equivalent) | October 20, 2025 | 0.5% |
| ALCON LABORATORIES INC | 080027 | AT (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 0.5% |
Questions
Is there a generic for Ophthaine?
Yes. The generic name for Ophthaine is proparacaine. 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 Ophthaine?
The active ingredient in Ophthaine is proparacaine, 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.