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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 091276

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NDA 091276 describes INDOMETHACIN, which is a drug marketed by Able, Amneal Pharms, Aurobindo Pharma, Avanthi Inc, Chartwell Rx, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Inwood Labs, Jubilant Generics, Mylan, Novast Labs, Sandoz, Watson Labs Inc, Zydus Pharms, Ani Pharms, Chartwell Molecules, Cycle, Duramed Pharms Barr, Halsey, Heritage, Heritage Pharma, Ivax Sub Teva Pharms, Mutual Pharm, Parke Davis, Pioneer Pharms, Rising, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Teva, Watson Labs, Zydus Lifesciences, Fresenius Kabi Usa, Amneal, Annora Pharma, Cosette, Hikma, Novitium Pharma, Hospira, and Navinta Llc, and is included in sixty-seven NDAs. It is available from thirty-one suppliers. Additional details are available on the INDOMETHACIN profile page.

The generic ingredient in INDOMETHACIN is indomethacin sodium. There are fifteen drug master file entries for this compound. Additional details are available on the indomethacin sodium profile page.

Summary for 091276

Tradename:	INDOMETHACIN
Applicant:	Glenmark Pharms Ltd
Ingredient:	indomethacin
Patents:	0

Pharmacology for NDA: 091276

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 091276

Anti-Inflammatory Agents, Non-Steroidal
Cardiovascular Agents
Cyclooxygenase Inhibitors
Gout Suppressants
Tocolytic Agents

Suppliers and Packaging for NDA: 091276

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
INDOMETHACIN	indomethacin	CAPSULE;ORAL	091276	ANDA	PD-Rx Pharmaceuticals, Inc.	43063-368	43063-368-06	6 CAPSULE in 1 BOTTLE, PLASTIC (43063-368-06)
INDOMETHACIN	indomethacin	CAPSULE;ORAL	091276	ANDA	PD-Rx Pharmaceuticals, Inc.	43063-368	43063-368-15	15 CAPSULE in 1 BOTTLE, PLASTIC (43063-368-15)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Dec 22, 2010	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	Dec 22, 2010	TE:	AB	RLD:	No

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