FDA Orange Book
Generic for Ophthetic
Ophthetic 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 Ophthetic 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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Ophthetic 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 012583, held by ALLERGAN PHARMACEUTICAL. 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 Ophthetic?
Yes. The generic name for Ophthetic 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 Ophthetic?
The active ingredient in Ophthetic 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.