FDA Orange Book
Generic for Iopidine
Iopidine contains apraclonidine. 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 Iopidine is apraclonidine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT. Generics match 1 of the 2 Iopidine products the Orange Book lists.
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Iopidine products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | EQ 0.5% BASE | Marketed (Rx) | AT | 1 | AT |
| solution/drops, ophthalmic | EQ 1% BASE | Marketed (Rx) | None | 0 | None |
NDA 020258, 019779, held by HARROW EYE LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic apraclonidine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| RISING PHARMA HOLDINGS INC | 077764 | AT (A-rated, therapeutically equivalent) | March 12, 2009 | EQ 0.5% BASE |
Iopidine NDC codes
Questions
Is there a generic for Iopidine?
Yes. The generic name for Iopidine is apraclonidine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT. Generics match 1 of the 2 Iopidine products the Orange Book lists.
What is the generic name for Iopidine?
The active ingredient in Iopidine is apraclonidine, 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.