Last Updated: September 24, 2026

Details for New Drug Application (NDA): 021903

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NDA 021903 describes NEOPROFEN, which is a drug marketed by Recordati Rare and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the NEOPROFEN profile page.

The generic ingredient in NEOPROFEN is ibuprofen lysine. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the ibuprofen lysine profile page.

Summary for 021903

Tradename:	NEOPROFEN
Applicant:	Recordati Rare
Ingredient:	ibuprofen lysine
Patents:	1

Pharmacology for NDA: 021903

Mechanism of Action	Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 021903

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903	NDA	Recordati Rare Diseases Inc.	55292-122	55292-122-52	3 VIAL in 1 CARTON (55292-122-52) / 2 mL in 1 VIAL
NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903	NDA AUTHORIZED GENERIC	Prasco Laboratories	66993-490	66993-490-36	3 VIAL in 1 CARTON (66993-490-36) / 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)
Approval Date:	Apr 13, 2006	TE:	AP	RLD:	Yes
Patent:	8,415,337	Patent Expiration:	Mar 2, 2032	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 021903

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	6,342,530	⤷ Start Trial
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	6,344,479	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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