Quick answers
- What is Ibuprofen lysine used for?
- The FDA-approved label (Neoprofen, Recordati Rare Diseases Inc., October 15, 2024) says: “NeoProfen 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ibuprofen lysine have a boxed warning?
- No. None of the 3 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Ibuprofen lysine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ibuprofen lysine been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started February 8, 2017 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Ibuprofen lysine?
- 3 companies list prescription products of Ibuprofen lysine in the FDA NDC Directory, including Recordati Rare Diseases, Inc., XGen Pharmaceuticals DJB, Inc. and Prasco Laboratories.
What Ibuprofen lysine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
NeoProfen 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. …
— FDA label: Neoprofen, Recordati Rare Diseases Inc., effective October 15, 2024. Read the full label on DailyMed →
The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Solution |
|---|---|
| Route | Intravenous |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Neoprofen |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Recordati Rare Diseases, Inc.1 product
- XGen Pharmaceuticals DJB, Inc.1 product
- Prasco Laboratories1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021903 NEOPROFEN | Recordati Rare | April 13, 2006 | 9, latest October 25, 2023 2023: Labeling · 2021: Labeling · 2019: Labeling |
Generic approvals (1)
- ANDA202402Xgen Pharms · March 30, 2016
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
February 8, 2017 · Class I · Terminated · D-0637-2017
Presence of Particulate Matter
Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC 39822-1030-1), packaged in 3 x 2 mL Single-Dose Vials per carton (NDC 39822-1030-2); Rx only, Distributed by: X-Gen Pharmaceuticals, Inc., Big — X-Gen Pharmaceuticals Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 637197, 1747294 |
|---|---|
| SPL set ID of the quoted label | 6f5ede6f-b0b7-4fc8-969e-652f60ead047 |
| FDA labels (SPL) | 3 |
| FDA applications | NDA021903, 1 ANDA |
| Active ingredients (FDA) | IBUPROFEN LYSINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Neoprofen, Recordati Rare Diseases Inc., effective October 15, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →