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Last Updated: March 26, 2025

Details for New Drug Application (NDA): 215899

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NDA 215899 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, Cosette, Hikma, Novitium Pharma, Hospira, and Navinta Llc, and is included in sixty-five NDAs. It is available from thirty 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 215899

Tradename:	INDOMETHACIN
Applicant:	Hikma
Ingredient:	indomethacin
Patents:	0

Pharmacology for NDA: 215899

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 215899

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

Suppliers and Packaging for NDA: 215899

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
INDOMETHACIN	indomethacin	SUPPOSITORY;RECTAL	215899	ANDA	Hikma Pharmaceuticals USA Inc.	0054-1950	0054-1950-30	30 SUPPOSITORY in 1 BOX (0054-1950-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUPPOSITORY;RECTAL			Strength	50MG
Approval Date:	Nov 19, 2024	TE:	AB	RLD:	No

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