Indomethacin

Sold as Indocin, Indocin Sr, Indomethacin, Tivorbex. Every FDA application for this active ingredient: 12 branded and 59 generic.

As of Nov 15, 2026, FDA lists 71 applications for Indomethacin (sold as Indocin, Indocin Sr, Indomethacin and others), first approved Jun 10, 1965, with 1 new use approved and 0 published complete response letters.

First approved: Jun 10, 1965
Applications: 71
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $4.6M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Indomethacin	Part D	$3.8M	+6%	120,659
Indomethacin ER	Part D	$529K	-16%	8,295
Indocin	Part D	$308K	-42%	15

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

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


Epidural Analgesia Versus Opioid-sparing Analgesia for Open Ventral Hernia Repair With Transversus Abdominis ReleaseVentral Hernia, Ventral Hernia Repair · Northwestern University	Phase 4	Recruiting	Sep 24, 2026
Rectal Indomethacin With or Without Papillary Ice Water Irrigation to Prevent Post-ERCP PancreatitisPancreatitis · Unity Health Toronto	Not applicable	Not yet recruiting	Sep 17, 2026
Pain Control During Hysterosalpingography: A Three-Arm Randomized TrialHysterosalpingography-Related Pain · Balikesir University	Phase 4	Not yet recruiting	Aug 28, 2026
Short-Stay Aggressive Hydration to Prevent Post-ERCP PancreatitisPost-ERCP Pancreatitis, Pancreatitis · Westmead Hospital	Not applicable	Recruiting	Aug 20, 2026
Pain Control With Ketorolac and Nerve Block After Wrist and Hand SurgerySurgery, Upper Extremity · University of Chicago	Phase 4	Recruiting	Aug 19, 2026
NSAIDS Following Elective Lumbar Spine FusionNSAID (Non-Steroidal Anti-Inflammatory Drug), Lumbar Spine Fusion · Rothman Institute Orthopaedics	Phase 3	Enrolling by invitation	Aug 4, 2026
Cold and NSAID Trial for Prevention of Post-ERCP PancreatitisPancreatitis, Acute · Instituto do Cancer do Estado de São Paulo	Not applicable	Recruiting	Jul 30, 2026
Indomethacin for Biliary ERCP PatientsPancreatitis Biliary, Pancreatitis Acute Biliary · University of California, San Francisco	Phase 4	Not yet recruiting	Jun 22, 2026

Applications

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


Jun 10, 1965	IndocinNDA 16059 · New molecular entity	Zyla Life Sciences	54	Discontinued
Feb 23, 1982	Indocin SrNDA 18185 · New dosage form	Zyla	42	Discontinued
Apr 20, 1984	IndomethacinNDA 18858	Rising	29	Discontinued
May 4, 1984	IndomethacinNDA 18730	Ivax Sub Teva Pharms	2	Discontinued
May 18, 1984	IndomethacinNDA 18851	Heritage	17	Discontinued
Aug 6, 1984	IndomethacinNDA 18829	Chartwell Molecules	17	Marketed
Aug 13, 1984	IndocinNDA 17814 · New dosage form	Cosette	30	Discontinued
Sep 4, 1985	IndomethacinANDA 70624	Rising	25	Discontinued
Oct 10, 1985	IndocinNDA 18332 · New dosage form	Cosette	28	Marketed
Oct 18, 1985	IndomethacinANDA 70326	Duramed Pharms Barr	5	Discontinued
Oct 18, 1985	IndomethacinANDA 70327	Duramed Pharms Barr	5	Discontinued
Nov 7, 1985	Indo-LemmonANDA 70266	Teva	22	Discontinued
Nov 7, 1985	Indo-LemmonANDA 70267	Teva	23	Discontinued
Feb 12, 1986	IndomethacinANDA 70756	Heritage Pharma	24	Discontinued
Feb 12, 1986	IndomethacinANDA 70719	Heritage Pharma	21	Discontinued
Mar 5, 1986	IndomethacinANDA 70651	Chartwell Molecules	17	Marketed
Oct 3, 1986	IndomethacinANDA 70067	Mutual Pharm	11	Discontinued
Oct 3, 1986	IndomethacinANDA 70068	Mutual Pharm	11	Discontinued
Oct 10, 1986	IndomethacinANDA 70488	Superpharm	2	Discontinued
Feb 9, 1987	IndomethacinANDA 70900	Sun Pharm Industries	17	Discontinued
Mar 18, 1987	IndomethacinANDA 71148	Ani Pharms	16	Discontinued
Mar 18, 1987	IndomethacinANDA 71149	Ani Pharms	16	Discontinued
Mar 18, 1987	IndomethacinANDA 71412	Hikma	0	Discontinued
Apr 29, 1987	IndomethacinANDA 70674	Sandoz	14	Marketed
Apr 29, 1987	IndomethacinANDA 70673	Sandoz	14	Marketed
May 18, 1987	IndomethacinANDA 71635	Watson Labs	4	Discontinued
Apr 18, 1988	IndomethacinANDA 71342	Teva	14	Discontinued
Apr 18, 1988	IndomethacinANDA 71343	Teva	13	Discontinued
Mar 15, 1989	IndomethacinANDA 72410	Inwood Labs	9	Discontinued
Jul 31, 1991	IndomethacinANDA 72996	Watson Labs	0	Discontinued
Jul 31, 1991	IndomethacinANDA 72997	Watson Labs	0	Discontinued
Aug 31, 1992	IndomethacinANDA 73314	Cosette	9	Marketed
May 28, 1998	IndomethacinANDA 74464	Sandoz	10	Discontinued
Feb 6, 2002	IndomethacinANDA 76114	Able	5	Discontinued
Dec 17, 2003	IndomethacinANDA 76666	Able	0	Discontinued
Mar 6, 2009	IndomethacinANDA 79175	Avanthi Inc	3	Marketed
Mar 17, 2010	IndomethacinNDA 22536 · New formulation or manufacturer	Fresenius Kabi USA	2	Marketed
Nov 15, 2010	IndomethacinANDA 90403	Zydus Lifesciences	6	Marketed
Nov 30, 2010	IndomethacinANDA 200529	Chartwell Rx	4	Marketed
Dec 1, 2010	IndomethacinANDA 91549	Amneal Pharms	8	Marketed
Dec 22, 2010	IndomethacinANDA 91276	Glenmark Pharms Ltd	5	Marketed
Apr 12, 2011	IndomethacinANDA 91240	Hetero Labs Ltd Iii	4	Marketed
Sep 28, 2012	IndomethacinANDA 201807	Hetero Labs Ltd Iii	3	Marketed
Mar 28, 2013	IndomethacinANDA 91401	Sun Pharm Inds Inc	4	Discontinued
Dec 9, 2013	IndomethacinANDA 202572	Watson Labs Inc	3	Discontinued
Feb 24, 2014	TivorbexNDA 204768 · New dosage form	Genus	5	Discontinued
Mar 20, 2014	IndomethacinANDA 202139	Mylan	6	Discontinued
Oct 5, 2015	IndomethacinANDA 202706	Jubilant Generics	4	Discontinued
Dec 27, 2016	IndomethacinANDA 204243	Aurobindo Pharma	0	Discontinued
May 8, 2017	IndomethacinANDA 204853	Novast Labs	2	Marketed
Jun 22, 2017	IndomethacinANDA 203501	Glenmark Pharms Ltd	3	Marketed
Aug 25, 2017	IndomethacinANDA 205215	Jubilant Generics	2	Discontinued
Sep 25, 2017	IndomethacinANDA 202711	Zydus Pharms	3	Marketed
Aug 2, 2023	IndomethacinANDA 216184	Zydus Lifesciences	1	Marketed
Jan 12, 2024	IndomethacinANDA 217883	Novitium Pharma	1	Marketed
Nov 19, 2024	IndomethacinANDA 215899	Hikma	1	Marketed
Feb 24, 2025	IndomethacinANDA 215399	Amneal	0	Marketed
Jul 3, 2025	IndomethacinANDA 216905	Annora Pharma	0	Marketed
—	IndomethacinNDA 18690	Watson Labs	0	Discontinued
—	IndomethacinNDA 18806	Parke Davis	0	Discontinued
—	IndomethacinANDA 70635	Halsey	0	Discontinued
—	IndomethacinANDA 70353	Cycle	0	Discontinued
—	IndomethacinANDA 70354	Cycle	0	Discontinued
—	IndomethacinANDA 70487	Superpharm	0	Discontinued
—	IndomethacinANDA 70529	Watson Labs	0	Discontinued
—	IndomethacinANDA 70530	Watson Labs	0	Discontinued
—	IndomethacinANDA 70592	Pioneer Pharms	0	Discontinued
—	IndomethacinANDA 70782	Halsey	0	Discontinued
—	IndomethacinANDA 70784	Watson Labs	0	Discontinued
—	IndomethacinANDA 70785	Watson Labs	0	Discontinued
—	IndomethacinANDA 70813	Pioneer Pharms	0	Discontinued

Show all 71

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