Prescription medicine
Ibuprofen lysine Brand names: Neoprofen
Ibuprofen lysine (Neoprofen) is a prescription medicine with an FDA approval on record since 2006. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
Check it at the source: the ibuprofen lysine FDA label on DailyMed (effective October 15, 2024, Recordati Rare Diseases Inc.); the NDA 21903 record on Drugs@FDA; every ibuprofen lysine label on DailyMed.
Highlights of the record
FDA label of October 15, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageNeoProfen is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective.
Forms and strengths
- 10 mg/ml
Solution.
On the market
- Earliest approval on file
- April 13, 2006 Neoprofen, Recordati Rare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first March 30, 2016; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 1 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 2, 2032 Neoprofen injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2017 1 Class I among all firms' recalls; latest February 8, 2017
- FAERS reports
- 564 through July 30, 2026
What is ibuprofen lysine used for?
From the label: indications and usageNeoProfen is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective. The clinical trial was conducted among infants with an asymptomatic PDA. However, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant PDA. […]
FDA pharmacologic class: Nonsteroidal Anti-inflammatory Drug.
Source: FDA drug label (NEOPROFEN), Recordati Rare Diseases Inc., effective October 15, 2024 (SPL set 6f5ede6f-b0b7-4fc8-969e-652f60ead047), via openFDA; the full label on DailyMed
Is there a generic for ibuprofen lysine (Neoprofen)?
The FDA approved the first generic ibuprofen lysine on March 30, 2016. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists ibuprofen lysine from 1 labeler under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Neoprofen injection: the compound patent runs to March 2, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2006 earliest approval on file
- 2016 first generic approved
- 2032 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has ibuprofen lysine been recalled?
The FDA's Enforcement Report lists 1 recall naming ibuprofen lysine since 2017: 1 Class I (the most serious), 0 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 8, 2017 | Class I | X-Gen Pharmaceuticals Inc. | Presence of Particulate Matter |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ibuprofen lysine label say about other medicines?
The ibuprofen lysine label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amikacin | drug interactions | Ibuprofen may decrease the clearance of amikacin. |
| Ibuprofen | drug interactions | DRUG INTERACTIONS Diuretics: Ibuprofen may reduce the effect of diuretics; diuretics can increase the risk of nephrotoxicity of NSAIDs in dehydrated patients. |
Source: FDA drug label (NEOPROFEN), Recordati Rare Diseases Inc., effective October 15, 2024 (SPL set 6f5ede6f-b0b7-4fc8-969e-652f60ead047), via openFDA; the full label on DailyMed
What do FAERS reports show for ibuprofen lysine?
The FDA Adverse Event Reporting System holds 564 reports that list ibuprofen lysine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 94 are coded as a death and 134 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other NSAIDs
- the pharmacologic class, with prices and generics
- Ibuprofen lysine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other