Indomethacin Sodium

Sold as Indocin. Every FDA application for this active ingredient: 1 branded and 3 generic.

As of Nov 15, 2026, FDA lists 4 applications for Indomethacin Sodium (sold as Indocin), first approved Jan 30, 1985, with 0 new uses approved and 0 published complete response letters.

First approved: Jan 30, 1985
Applications: 4
New uses approved: 0
Complete response letters: 0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

INDOMETHACIN 25 MG CAPSULE: $0.100 per unitGeneric · -8% in a year
INDOMETHACIN 50 MG CAPSULE: $0.124 per unitGeneric · -7% in a year
INDOMETHACIN ER 75 MG CAPSULE: $0.219 per unitGeneric · +5% in a year

Clinical Trials

6 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Paracervical Block With Combined Ketorolac and Lidocaine for Osmotic Dilator PlacementPain Management, Abortion · Rush University Medical Center	Phase 2	Recruiting	Mar 23, 2026
Study on Ketorolac for Improving Outcomes and Prognosis in Patients With Stanford Type A Aortic DissectionAortic Dissection, Inflammation · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Phase 3	Recruiting	May 13, 2025
Mepilex Lite Dressings for the Treatment of Acute Radiation Dermatitis of Anal Canal SkinRectal Cancer, Radiotherapy, Anal Pain · Qianfoshan Hospital	Not applicable	Recruiting	Feb 20, 2025
Ketorolac Intravenous Regional Analgesia in Lower Limb SurgeriesPostoperative Pain, Acute · Mansoura University	Not applicable	Recruiting	Sep 16, 2022
Role of Multimodal Analgesia in Decreasing Perioperative Pain in Tibial Plateau FracturesTibial Plateau Fractures · University of Utah	Early phase 1	Active, not recruiting	Sep 8, 2021
Treatment of Orthostatic IntoleranceTachycardia, Chronic Orthostatic Intolerance · Satish R. Raj	Phase 1 / Phase 2	Active, not recruiting	Dec 6, 2005

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jan 30, 1985	IndocinNDA 18878 · New dosage form	Recordati Rare	17	Discontinued
Jul 16, 2008	Indomethacin SodiumANDA 78713	Hikma	0	Discontinued
Apr 19, 2016	Indomethacin SodiumANDA 204118	Hospira	1	Discontinued
Jul 19, 2017	Indomethacin SodiumANDA 206561	Navinta LLC	1	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA