Quick answers
- What is Indocin?
- Indocin is a brand name of Indomethacin, a prescription medicine. The FDA NDC Directory lists 2 Indocin products in 2 strengths and forms.
- Who makes Indocin?
- Cosette holds the FDA application for Indocin (NDA018332, approved October 10, 1985). 1 other company (repackagers or distributors) also list Indocin products.
- Is there a generic or store brand of Indocin?
- Yes. The FDA NDC Directory lists 8 other products with the same active ingredients, strength and form as a Indocin product, 8 of them generic. Ask your pharmacist whether one is right for you.
- Has Indocin been recalled?
- No recall linked to Indocin products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Indocin is
Each Indocin product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Indomethacin · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| indomethacin 25 mg/5 mL suspension (oral) | Indocin | 1 product, 1 company | DailyMed |
| indomethacin 50 mg suppository (rectal) | Indocin | 7 products, 6 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Indomethacin →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA018332 | Cosette | October 10, 1985 | 1 |
| ANDA073314 | Cosette | August 31, 1992 | 1 |
Companies that list Indocin
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Indocin products.
- Zyla Life Sciences US Inc.1 product
- Zyla Life Sciences US LLC1 product
Recalls
No recall linked to Indocin products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.