NEOPROFEN

Product NDC: 55292-122
11-digit product format: 552920122
Labeler code: 55292
Product ID: 55292-122_5b563933-e1a3-418c-a1fd-0433d1d9233f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ibuprofen lysine
Dosage form: SOLUTION
Route: INTRAVENOUS
Labeler: Recordati Rare Diseases Inc.
Application: NDA021903
Marketing category: NDA
Marketing start: 2006-04-13
Substance: IBUPROFEN LYSINE
Active strength: 10 mg/mL
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN LYSINE	10 mg/mL

Field, Values table
Field	Values
Unii	N01ORX9D6S
Rxcui	637197, 1747294

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55292-122-52	NEOPROFEN	2 mL in 1 VIAL	SOLUTION	2		17
55292-122-52	NEOPROFEN	3 in 1 CARTON	SOLUTION	3		17

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55292-122-52	ML - Milliliter	55292-122	6d3cdfea-a7a6-48a1-afa8-1bca1204998a	1	2013-12-02

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN LYSINE	ACTIVE INGREDIENT	N01ORX9D6S	NEOPROFEN (IBUPROFEN LYSINE) SOLUTION [RECORDATI RARE DISEASES, INC.]	4
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	NEOPROFEN (IBUPROFEN LYSINE) SOLUTION [RECORDATI RARE DISEASES, INC.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	NEOPROFEN (IBUPROFEN LYSINE) SOLUTION [RECORDATI RARE DISEASES, INC.]	4

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55292-122	NEOPROFEN (IBUPROFEN LYSINE) SOLUTION [RECORDATI RARE DISEASES INC.]	17	Current NDC, Legacy NDC, 2 package rows	20241017_6f5ede6f-b0b7-4fc8-969e-652f60ead047.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N01ORX9D6S	IBUPROFEN LYSINE	57469-77-9	IBUPROFEN LYSINE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1747294	ibuprofen lysine 10 MG/ML in 2 ML Injection	PSN	6f5ede6f-b0b7-4fc8-969e-652f60ead047	17
637197	NeoProfen 10 MG/ML in 2 ML Injection	PSN	6f5ede6f-b0b7-4fc8-969e-652f60ead047	17
637197	2 ML ibuprofen 10 MG/ML Injection [Neoprofen]	SBD	6f5ede6f-b0b7-4fc8-969e-652f60ead047	17
1747294	2 ML ibuprofen 10 MG/ML Injection	SCD	6f5ede6f-b0b7-4fc8-969e-652f60ead047	17
637197	2 ML Neoprofen 10 MG/ML Injection	SY	6f5ede6f-b0b7-4fc8-969e-652f60ead047	17
1747294	ibuprofen 10 MG/ML (as ibuprofen lysine 17.1 MG/ML) per 2 ML Injection	SY	6f5ede6f-b0b7-4fc8-969e-652f60ead047	17
637197	NeoProfen 10 MG/ML (as ibuprofen lysine 17.1 MG/ML) per 2 ML Injection	SY	6f5ede6f-b0b7-4fc8-969e-652f60ead047	17

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55292-122-52	55292012252	3 VIAL in 1 CARTON (55292-122-52) / 2 mL in 1 VIAL	3 vial	2006-04-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NEOPROFEN	Recordati Rare Diseases Inc. \| Alcami Carolinas Corporation	2024-10-15	HUMAN PRESCRIPTION DRUG LABEL	17