FDA Orange Book
Generic for Indocin
Indocin contains indomethacin. 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 Indocin is indomethacin. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 5 Indocin products the Orange Book lists.
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Indocin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 25MG | Discontinued | None | 4 | AB |
| capsule, oral | 50MG | Discontinued | None | 5 | AB |
| injectable, injection | EQ 1MG BASE/VIAL | Discontinued | None | 0 | None |
| suppository, rectal | 50MG | Discontinued | None | 5 | AB |
| suspension, oral | 25MG/5ML | Marketed (Rx) | AB | 1 | AB |
NDA 016059, 018878, 017814, 018332, held by ZYLA LIFE SCIENCES US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic indomethacin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CHARTWELL MOLECULES LLC | 070651 | AB (A-rated, therapeutically equivalent) | March 5, 1986 | 50MG |
| SANDOZ INC | 070673 | AB (A-rated, therapeutically equivalent) | April 29, 1987 | 25MG |
| SANDOZ INC | 070674 | AB (A-rated, therapeutically equivalent) | April 29, 1987 | 50MG |
| COSETTE PHARMACEUTICALS INC | 073314 | AB (A-rated, therapeutically equivalent) | August 31, 1992 | 50MG |
| ZYDUS LIFESCIENCES LTD | 090403 | AB (A-rated, therapeutically equivalent) | November 15, 2010 | 25MG, 50MG |
| GLENMARK PHARMACEUTICALS LTD | 091276 | AB (A-rated, therapeutically equivalent) | December 22, 2010 | 25MG, 50MG |
| HETERO LABS LTD UNIT III | 091240 | AB (A-rated, therapeutically equivalent) | April 12, 2011 | 25MG, 50MG |
| ZYDUS LIFESCIENCES GLOBAL FZE | 216184 | AB (A-rated, therapeutically equivalent) | August 2, 2023 | 50MG |
| NOVITIUM PHARMA LLC | 217883 | AB (A-rated, therapeutically equivalent) | January 12, 2024 | 25MG/5ML |
| HIKMA PHARMACEUTICALS USA INC | 215899 | AB (A-rated, therapeutically equivalent) | November 19, 2024 | 50MG |
| AMNEAL PHARMACEUTICALS LLC | 215399 | AB (A-rated, therapeutically equivalent) | February 24, 2025 | 50MG |
| ANNORA PHARMA PRIVATE LTD | 216905 | AB (A-rated, therapeutically equivalent) | July 3, 2025 | 50MG |
Indocin NDC codes
Questions
Is there a generic for Indocin?
Yes. The generic name for Indocin is indomethacin. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 5 Indocin products the Orange Book lists.
What is the generic name for Indocin?
The active ingredient in Indocin is indomethacin, 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.