FDA Orange Book
Generic for Isopto Carpine
Isopto Carpine contains pilocarpine. 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 Isopto Carpine is pilocarpine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
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Isopto Carpine products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | 1% | Marketed (Rx) | AT | 4 | AT |
| solution/drops, ophthalmic | 2% | Marketed (Rx) | AT | 4 | AT |
| solution/drops, ophthalmic | 4% | Marketed (Rx) | AT | 4 | AT |
NDA 200890, held by SANDOZ INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic pilocarpine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| RISING PHARMA HOLDINGS INC | 204398 | AT (A-rated, therapeutically equivalent) | September 27, 2017 | 1%, 2%, 4% |
| SOMERSET THERAPEUTICS LLC | 210384 | AT (A-rated, therapeutically equivalent) | November 25, 2019 | 1%, 2%, 4% |
| AMNEAL EU LTD | 214193 | AT (A-rated, therapeutically equivalent) | September 21, 2020 | 1%, 2%, 4% |
| FDC LTD | 217052 | AT (A-rated, therapeutically equivalent) | October 2, 2025 | 1%, 2%, 4% |
Isopto Carpine NDC codes
Questions
Is there a generic for Isopto Carpine?
Yes. The generic name for Isopto Carpine is pilocarpine. 4 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 Isopto Carpine?
The active ingredient in Isopto Carpine is pilocarpine, 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.