FDA Orange Book
Generic for Ic-green
Ic-green contains indocyanine green. 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 Ic-green is indocyanine green. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 4 Ic-green products the Orange Book lists.
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Ic-green products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 10MG/VIAL | Marketed (Rx) | None | 0 | None |
| injectable, injection | 25MG/VIAL | Marketed (Rx) | AP | 2 | AP |
| injectable, injection | 40MG/VIAL | Discontinued | None | 0 | None |
| injectable, injection | 50MG/VIAL | Discontinued | None | 0 | None |
NDA 011525, held by RENEW PHARMACEUTICALS LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic indocyanine green
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| RENEW PHARMACEUTICALS LTD | 040811 | AP (A-rated, therapeutically equivalent) | November 21, 2007 | 25MG/VIAL |
| ZYDUS LIFESCIENCES GLOBAL FZE | 219139 | AP (A-rated, therapeutically equivalent) | August 3, 2026 | 25MG/VIAL |
Questions
Is there a generic for Ic-green?
Yes. The generic name for Ic-green is indocyanine green. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 4 Ic-green products the Orange Book lists.
What is the generic name for Ic-green?
The active ingredient in Ic-green is indocyanine green, 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.