FDA Orange Book
Generic for Indocin SR
Indocin SR 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 SR is indomethacin. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Indocin SR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | 75MG | Discontinued | None | 7 | AB |
NDA 018185, held by ZYLA LIFE SCIENCES US INC. 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 |
|---|---|---|---|---|
| AVANTHI INC | 079175 | AB (A-rated, therapeutically equivalent) | March 6, 2009 | 75MG |
| CHARTWELL RX SCIENCES LLC | 200529 | AB (A-rated, therapeutically equivalent) | November 30, 2010 | 75MG |
| AMNEAL PHARMACEUTICALS | 091549 | AB (A-rated, therapeutically equivalent) | December 1, 2010 | 75MG |
| HETERO LABS LTD UNIT III | 201807 | AB (A-rated, therapeutically equivalent) | September 28, 2012 | 75MG |
| NOVAST LABORATORIES LTD | 204853 | AB (A-rated, therapeutically equivalent) | May 8, 2017 | 75MG |
| GLENMARK PHARMACEUTICALS LTD | 203501 | AB (A-rated, therapeutically equivalent) | June 22, 2017 | 75MG |
| ZYDUS PHARMACEUTICALS USA INC | 202711 | AB (A-rated, therapeutically equivalent) | September 25, 2017 | 75MG |
Questions
Is there a generic for Indocin SR?
Yes. The generic name for Indocin SR is indomethacin. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Indocin SR?
The active ingredient in Indocin SR 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.