Drug
Who makes indomethacin?
31 companies list indomethacin as a human prescription drug, including under the names Indocin. Forms: capsule; capsule, extended release; injection, powder, lyophilized, for solution; suppository; suspension. Routes: intravenous, oral, rectal.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing indomethacin
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | capsule; capsule, extended release | ANDAANDA079175, ANDA091240, ANDA091276 | 15 | 1 |
| International Medication Systems, Ltd.United States | capsule | ANDAANDA091240, ANDA091276 | 7 | 3 |
| PD-Rx Pharmaceuticals Inc.United States | capsule; capsule, extended release | ANDAANDA079175, ANDA091240, ANDA091276 | 6 | 1 |
| Proficient Rx LPUnited States | capsule; capsule, extended release | ANDAANDA091240, ANDA091276, ANDA201807 | 5 | 1 |
| Camber Pharmaceuticals, Inc.United States | capsule; capsule, extended release; suppository | ANDAANDA091240, ANDA201807, ANDA216905 | 4 | 1 |
| Northwind Health Company, LLCUnited States | capsule; capsule, extended release | ANDAANDA091240, ANDA091276, ANDA201807 | 4 | 1 |
| Glenmark Pharmaceuticals Inc., USAIndia | capsule; capsule, extended release | ANDAANDA091276, ANDA203501 | 3 | 9 |
| Direct RxUnited States | capsule | ANDAANDA091240, ANDA091276 | 3 | 1 |
| NuCare Pharmaceuticals,Inc.United States | capsule | ANDAANDA091240, ANDA091276 | 3 | 1 |
| Preferred Pharmaceuticals Inc.United States | capsule | ANDAANDA091240, ANDA091276 | 3 | 1 |
| RemedyRepack, IncUnited States | capsule; capsule, extended release | ANDAANDA091276, ANDA201807 | 3 | 1 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | capsule; capsule, extended release | ANDAANDA091240, ANDA201807 | 2 | 1 |
| St. Mary's Medical Park PharmacyUnited States | capsule | ANDAANDA091240, ANDA091276 | 2 | 1 |
| XLCare Pharmaceuticals Inc.United States | capsule | ANDAANDA091240 | 2 | 1 |
| Zydus Pharmaceuticals USA Inc.India | suppository | ANDAANDA216184 | 2 | 1 |
| AvPAK | capsule | ANDAANDA091240 | 2 | 0 |
| Chartwell RX, LLC. | capsule | ANDA, NDA AUTHORIZED GENERICANDA070651, NDA018829 | 2 | 0 |
| Zyla Life Sciences US Inc. | suppository; suspension | ANDA, NDAANDA073314, NDA018332 | 2 | 0 |
| Zydus Lifesciences LimitedIndia | suppository | ANDAANDA216184 | 1 | 12 |
| Fresenius Kabi USA, LLCUnited States | injection, powder, lyophilized, for solution | NDANDA022536 | 1 | 6 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | capsule, extended release | ANDAANDA079175 | 1 | 5 |
| Hikma Pharmaceuticals USA Inc.United States | suppository | ANDAANDA215899 | 1 | 4 |
| KVK-TECH, INC.United States | capsule, extended release | ANDAANDA079175 | 1 | 2 |
| ADVANCED RX PHARMACY OF TENNESSEE LLCUnited States | capsule, extended release | ANDAANDA201807 | 1 | 1 |
| ANI Pharmaceuticals, Inc.United States | suspension | ANDAANDA217883 | 1 | 1 |
| Amneal Ireland LimitedIreland | capsule, extended release | ANDAANDA091549 | 1 | 1 |
| Coupler LLCUnited States | capsule | ANDAANDA091276 | 1 | 1 |
| RedPharm DrugUnited States | capsule | ANDAANDA091276 | 1 | 1 |
| Amneal Pharmaceuticals NY LLC | suppository | ANDAANDA215399 | 1 | 0 |
| NorthStar RxLLC | suppository | ANDAANDA216905 | 1 | 0 |
| Sportpharm LLC | capsule, extended release | ANDAANDA201807 | 1 | 0 |
Bulk ingredient listings
- FIS FABBRICA ITALIANA SINTETICI SPAItaly · 2 NDC
- AX Pharmaceutical CorpCanada · 1 NDC
- Agno Pharma JiangsuChina · 1 NDC
- Aurore Pharmaceuticals Private LimitedIndia · 1 NDC
- Hetero Drugs LimitedIndia · 1 NDC
- Macleods Pharmaceuticals LimitedIndia · 1 NDC
Orange Book patents
3 unexpired patents list indomethacin as the active ingredient, expiring between Apr 2030 and Apr 2030. Application holder: GENUS LIFESCIENCES INC.
Enquiry
Common questions
- Who makes indomethacin?
- 31 companies list indomethacin as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, International Medication Systems, Ltd., PD-Rx Pharmaceuticals Inc., Proficient Rx LP, Camber Pharmaceuticals, Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Indocin?
- 30 companies list indomethacin under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies indomethacin active ingredient?
- 6 companies list indomethacin as a bulk ingredient, including FIS FABBRICA ITALIANA SINTETICI SPA, AX Pharmaceutical Corp, Agno Pharma Jiangsu, Aurore Pharmaceuticals Private Limited.