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NEOPROFEN ibuprofen lysine 10 mg/mL Solution — NDC 55292-0122-52 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

NEOPROFEN ibuprofen lysine 10 mg/mL Solution — NDC 55292-122-52 (Billing 55292-0122-52)

by Recordati Rare Diseases Inc. · 3 VIAL in 1 CARTON / 2 mL in 1 VIAL

This is a package of NEOPROFEN ibuprofen lysine 10 mg/mL Solution from Recordati Rare Diseases Inc., marketed since Apr 2006 and currently FDA-listed. It is this product's only package size.

NDC 55292-0122-52
🏷️ FDA NDC (as labeled) 55292-122-52 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55292-122-52
Product NDC 55292-122
11-digit billing NDC 55292012252
NCPDP billing unit ML — per mL (volume)
RxCUI 637197, 1747294
UNII N01ORX9D6S
Application # NDA021903
SPL Set ID 6f5ede6f-b0b7-4fc8-969e-652f60ead047
Established class (EPC) Anti-Inflammatory Agents; Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors
Chemical class Non-Steroidal
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2006-04-13
Route INTRAVENOUS
Dosage form SOLUTION
Substance IBUPROFEN LYSINE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 66100020402010
GPI class NeoProfen
GCN Seq No 060994
GCN 27148
HICL code 033810
Ingredient (HICL) Ibuprofen Lysine/Pf
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A5
Therapeutic class — intermediate (HIC2) Cardiac Treatment Agents, Other
HIC3 code A5A
Therapeutic class — specific (HIC3) Patent Ductus Arteriosus Treat. Agents, Nsaid-Type
AHFS code 28:08.04.04
AHFS class Reversible Cox-1/Cox-2 Inhibitors
FDB label name NEOPROFEN 20 MG/2 ML VIAL
FDB brand name Neoprofen
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 060994
  • GCN: 27148
  • GPI-14 (Medi-Span): 66100020402010
  • HICL (First Databank): 033810
  • AHFS class code: 28:08.04.04
  • RxCUI (RxNorm): 637197
Why two NDCs? The FDA registers this code as 55292-122-52 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 55292-0122-52. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Other cardiac preparations, Antiinflammatory products for vaginal administration, Propionic acid derivatives
How it works Cyclooxygenase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name NEOPROFEN 20 MG/2 ML VIAL Ingredient Ibuprofen Lysine/Pf
📗 Our plain-language guide HelloPharmacist
  • Over-the-counter ibuprofen helps with minor aches and pains like headache, toothache, backache, muscle aches, cramps and cold symptoms, and it lowers fever. Prescription versions a...
  • If ibuprofen upsets your stomach, take it with food or milk. Use the lowest dose that works for the shortest time you need.
  • The more common ones are nausea, vomiting, gas, headache and dizziness. These are usually manageable, but tell me if they bother you.
  • Stop and get help if you have black or bloody stools, vomit blood, chest pain, trouble breathing, weakness on one side, slurred speech, a skin rash, or swelling of the face. Also c...
📖 Read our full Ibuprofen guide →
1
Nutrient depletion considerations

Ibuprofen lysine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Ibuprofen lysine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
55292-0122-52 You're viewing this Main listing 3 VIAL in 1 CARTON / 2 mL in 1 VIAL 2006-04-13 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ibuprofen Lysine 10 mg/mL 39822-1030-02 XGen 3 vials — AP FDA listed —
Neoprofen 10 mg/mLthis 55292-0122-52 Recordati 3 vials — AP FDA listed —
Ibuprofen Lysine 10 mg/mL 66993-0490-36 Prasco 3 vials — AP FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2006
First FDA approval
Apr 2006
📍
2026
Currently FDA-listed
20 years listed
🛡️
2032
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Mar 2032. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Apr 13, 2006 AP TE-rated RLD RS ⏳ ~5.4 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8415337 — drug substance
2006 2008 2010 2012 2014 2016 2018 2020 2022 2024 2026 2028 2030 2032
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (1)
PatentTypeUse codeExpires
US 8415337 ↗ Drug substance — Mar 2, 2032
Common questions
Is there a generic version of NEOPROFEN 20 MG/2 ML VIAL?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for NEOPROFEN 20 MG/2 ML VIAL. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

1 inactive ingredient listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerRecordati Rare Diseases Inc.
Application holderRECORDATI RARE DISEASES INC
FDA applicationNDA021903 (NDA)
Labeler code55292
First marketedApr 2006
Product typeHuman Prescription Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 166 words ▾

1 INDICATIONS AND USAGE 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. 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.

NeoProfen is a nonsteroidal anti-inflammatory drug 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 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.

( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION A course of therapy is three doses administered I.V. ( 2.1 ) An initial dose of 10 mg/kg (based on birth weight) is followed by two doses of 5 mg/kg each, after 24 and 48 hours ( 2.1 ) Do not administer if anuria or marked oliguria (<0.6 mL/kg/hr) is evident at the scheduled time of the second or third dose ( 2.1 )

2.1Recommended Dose A course of therapy is three doses of NeoProfen administered intravenously (administration via an umbilical arterial line has not been evaluated). An initial dose of 10 mg per kilogram is followed by two doses of 5 mg per kilogram each, after 24 and 48 hours. All doses should be based on birth weight.

If anuria or marked oliguria (urinary output <0.6 mL/kg/hr) is evident at the scheduled time of the second or third dose of NeoProfen, no additional dosage should be given until laboratory studies indicate that renal function has returned to normal. If the ductus arteriosus closes or is significantly reduced in size after completion of the first course of NeoProfen, no further doses are necessary. If during continued medical management the ductus arteriosus fails to close or reopens, then a second course of NeoProfen, alternative pharmacological therapy, or surgery may be necessary.

2.2Directions for Use For intravenous administration only. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use NeoProfen if particulate matter is observed.

After the first withdrawal from the vial, any solution remaining must be discarded because NeoProfen contains no preservative. For administration, NeoProfen should be diluted to an appropriate volume with dextrose or saline. NeoProfen should be prepared for infusion and administered within 30 minutes of preparation and infused continuously over a period of 15 minutes.

The drug should be administered via the IV port that is nearest the insertion site. After the first withdrawal from the vial, any solution remaining must be discarded because NeoProfen contains no preservative. Since NeoProfen is potentially irritating to tissues, it should be administered carefully to avoid extravasation.

NeoProfen should not be simultaneously administered in the same intravenous line with Total Parenteral Nutrition (TPN). If necessary, TPN should be interrupted for a 15-minute period prior to and after drug administration. Line patency should be maintained by using dextrose or saline.

💊 Dosage Forms and Strengths 54 words ▾

3 DOSAGE FORMS AND STRENGTHS 20 mg/2 mL (10 mg/mL) as a clear sterile preservative-free solution of the L-lysine salt of ibuprofen in a 2 mL single-use vial. 20 mg/2 mL (10 mg/mL) as a clear sterile preservative-free solution of the L-lysine salt of ibuprofen in a 2 mL single-use vial ( 3 )

⛔ Contraindications 160 words ▾

4 CONTRAINDICATIONS NeoProfen is contraindicated in: Preterm infants with proven or suspected infection that is untreated; Preterm infants with congenital heart disease in whom patency of the PDA is necessary for satisfactory pulmonary or systemic blood flow (e.g., pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta); Preterm infants who are bleeding, especially those with active intracranial hemorrhage or gastrointestinal bleeding; Preterm infants with thrombocytopenia; Preterm infants with coagulation defects; Preterm infants with or who are suspected of having necrotizing enterocolitis; Preterm infants with significant impairment of renal function.

NeoProfen is contraindicated in preterm infants: With proven or suspected infection that is untreated ( 4 ) With congenital heart disease in whom patency of the PDA is necessary for satisfactory pulmonary or systemic blood flow ( 4 ) With impaired renal function ( 4 ) With thrombocytopenia, coagulation defects or who are bleeding ( 4 ) With or who are suspected of having necrotizing enterocolitis ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS NeoProfen has not been assessed for neurodevelopmental outcome and growth ( 5.1 ) NeoProfen may alter the usual signs of infection ( 5.2 ) NeoProfen can inhibit platelet aggregation, and has been shown to prolong bleeding time in normal adult subjects ( 5.3 ) Ibuprofen has been shown to displace bilirubin from albumin binding-sites ( 5.4 ) NeoProfen should be administered carefully to avoid extravascular injection or leakage ( 5.5 ) NeoProfen may cause serious skin reactions ( 5.6 )

5.1General There are no long-term evaluations of the infants treated with ibuprofen at durations greater than the 36 weeks post-conceptual age observation period. Ibuprofen's effects on neurodevelopmental outcome and growth as well as disease processes associated with prematurity (such as retinopathy of prematurity and chronic lung disease) have not been assessed.

5.2Infection NeoProfen may alter the usual signs of infection. The physician must be continually on the alert and should use the drug with extra care in the presence of controlled infection and in infants at risk of infection.

5.3Platelet Aggregation NeoProfen, like other non-steroidal anti-inflammatory agents, can inhibit platelet aggregation. Preterm infants should be observed for signs of bleeding. Ibuprofen has been shown to prolong bleeding time (but within the normal range) in normal adult subjects. This effect may be exaggerated in patients with underlying hemostatic defects (see CONTRAINDICATIONS ).

5.4Bilirubin Displacement Ibuprofen has been shown to displace bilirubin from albumin binding-sites; therefore, it should be used with caution in patients with elevated total bilirubin.

5.5Administration NeoProfen should be administered carefully to avoid extravascular injection or leakage, as solution may be irritating to tissue.

5.6Serious Skin Reactions NSAIDS, including ibuprofen, can cause serious skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), which can be fatal. Ibuprofen should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions (≥10%) are sepsis, anemia, intraventricular bleeding, apnea, gastrointestinal disorders, impaired renal function, respiratory infection, skin lesions, hypoglycemia, hypocalcemia, respiratory failure. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience The most frequently reported adverse events with NeoProfen were as shown in Table 1. Table 1. Adverse Events within 30 Days of Therapy in the Multicenter Study* Adverse Event % Incidence NeoProfen Placebo * Within 30 days of therapy, with an event rate greater on NeoProfen than on placebo, and greater than 2 events on NeoProfen. ** A given subject may have experienced more than one specific event within these adverse event categories.

Only the most severe grade of IVH counted for a given subject. Sepsis 43 37 Anemia 32 25 Total Bleeding** 32 29 Intraventricular Hemorrhage, Grades 1/2 15 13 Intraventricular Hemorrhage, Grades 3/4 15 10 Other Bleeding 6 13 Intraventricular Hemorrhage, All Grades 29 24 Apnea 28 26 Gastrointestinal Disorders 22 18 non-Necrotizing Enterocolitis Total Renal Events** 21 15 Renal Failure 1 3 Renal Insufficiency, Impairment 6 4 Urine Output Reduced 3 1 Blood Creatinine Increased 3 1 Blood Urea Increased with Hematuria 1 1 Blood Urea Increased 7 4 Respiratory Infection 19 13 Skin Lesion/Irritation 16 6 Hypoglycemia 12 6 Hypocalcemia 12 9 Respiratory Failure 10 4 Urinary Tract Infection 9 4 Adrenal Insufficiency 7 1 Hypernatremia 7 4 Edema 4 0 Atelectasis 4 1

6.2Renal Function Compared to placebo, there was a small decrease in urinary output in the ibuprofen group on days 2-6 of life, with a compensatory increase in urine output on day 9. In other studies, adverse events classified as renal insufficiency including oliguria, elevated BUN, elevated creatinine, or renal failure were reported in ibuprofen treated infants.

6.3Additional Adverse Events The adverse events reported in the multicenter study and of unknown association include tachycardia, cardiac failure, abdominal distension, gastroesophageal reflux, gastritis, ileus, inguinal hernia, injection site reactions, cholestasis, various infections, feeding problems, convulsions, jaundice, hypotension, and various laboratory abnormalities including neutropenia, thrombocytopenia, and hyperglycemia.

6.4Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency, or establish a causal relationship to drug exposure. The following adverse reactions have been identified from spontaneous post-marketing reports or published literature: gastrointestinal perforation, necrotizing enterocolitis, drug reaction with eosinophilia and systemic symptoms (DRESS), and pulmonary hypertension.

🔄 Drug Interactions 48 words ▾

7 DRUG INTERACTIONS Diuretics: Ibuprofen may reduce the effect of diuretics; diuretics can increase the risk of nephrotoxicity of NSAIDs in dehydrated patients. Monitor renal function in patients receiving concomitant diuretics. Amikacin: Ibuprofen may decrease the clearance of amikacin. Diuretics: Increased risk of renal dysfunction. ( 7 )

👥 Use in Specific Populations 18 words ▾

8 USE IN SPECIFIC POPULATIONS

8.4Pediatric Use Safety and effectiveness have only been established in premature infants.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness have only been established in premature infants.

🆘 Overdosage 62 words ▾

10 OVERDOSAGE The following signs and symptoms have occurred in individuals (not necessarily in premature infants) following an overdose of oral ibuprofen: breathing difficulties, coma, drowsiness, irregular heartbeat, kidney failure, low blood pressure, seizures, and vomiting. There are no specific measures to treat acute overdosage with NeoProfen. The patient should be followed for several days because gastrointestinal ulceration and hemorrhage may occur.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action through which ibuprofen causes closure of a patent ductus arteriosus (PDA) in neonates is not known. In adults, ibuprofen is an inhibitor of prostaglandin synthesis.

12.2Pharmacokinetics and Bioavailability Studies The pharmacokinetic data were obtained from 54 NeoProfen-treated premature infants included in a double-blind, placebo-controlled, randomized, multicenter study. Infants were less than 30 weeks gestational age, weighed between 500 and 1000 g, and exhibited asymptomatic PDA with evidence of echocardiographic documentation of ductal shunting. Dosing was initially 10 mg/kg followed by 5 mg/kg at 24 and 48 hours.

The population average clearance and volume of distribution values of racemic ibuprofen for premature infants at birth were 3 mL/kg/h and 320 mL/kg, respectively. Clearance increased rapidly with post-natal age (an average increase of approximately 0.5 mL/kg/h per day). Inter-individual variability in clearance and volume of distribution were 55% and 14%, respectively.

In general, the half-life in infants is more than 10 times longer than in adults. The metabolism and excretion of ibuprofen in premature infants have not been studied. In adults, renal elimination of unchanged ibuprofen accounts for only 10-15% of the dose.

The excretion of ibuprofen and metabolites occurs rapidly in both urine and feces. Approximately 80% of the dose administered orally is recovered in urine as hydroxyl and carboxyl metabolites, respectively, as a mixture of conjugated and unconjugated forms. Ibuprofen is eliminated primarily by metabolism in the liver where CYP2C9 mediates the 2- and 3-hydroxylations of R- and S-ibuprofen.

Ibuprofen and its metabolites are further conjugated to acyl glucuronides. In neonates, renal function and the enzymes associated with drug metabolism are underdeveloped at birth and substantially increase in the days after birth.

🧬 Mechanism of Action 33 words ▾

12.1Mechanism of Action The mechanism of action through which ibuprofen causes closure of a patent ductus arteriosus (PDA) in neonates is not known. In adults, ibuprofen is an inhibitor of prostaglandin synthesis.

📦 How Supplied / Storage and Handling 137 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied NeoProfen (ibuprofen lysine) Injection is dispensed in treated NeoProfen (ibuprofen lysine) Injection is dispensed in a glass vial having a silicon dioxide coating or polymer coating that inhibits the formation of particulates that result from the interaction of the ibuprofen lysine with untreated glass. clear glass single-use vials, each containing 2 mL of sterile solution (NDC 55292-122-52). The solution is not buffered and contains no preservatives. Each milliliter contains 17.1 mg/mL (±)-ibuprofen L-lysine [equivalent to 10 mg/mL (±)-ibuprofen] dissolved in Water for Injection, USP.

NeoProfen is supplied in a carton containing 3 single-use vials. Storage and Handling Store at 20 – 25°C (68 – 77°F); excursions permitted 15 – 30°C (59 – 86°F) [see USP Controlled Room Temperature]. Protect from light.

Store vials in carton until contents have been used.

📦 Storage and Handling 36 words ▾

Storage and Handling Store at 20 – 25°C (68 – 77°F); excursions permitted 15 – 30°C (59 – 86°F) [see USP Controlled Room Temperature]. Protect from light. Store vials in carton until contents have been used.

📋 Description 127 words ▾

11 DESCRIPTION NeoProfen ® is a clear sterile preservative-free solution of the L-lysine salt of (±)-ibuprofen which is the active ingredient. (±)-Ibuprofen is a nonsteroidal anti-inflammatory agent (NSAID). L-lysine is used to create a water-soluble drug product salt suitable for intravenous administration.

Each mL of NeoProfen contains 17.1 mg of ibuprofen lysine (equivalent to 10 mg of (±)-ibuprofen) in Water for Injection, USP. The pH is adjusted to 7.0 with sodium hydroxide or hydrochloric acid. The structural formula is: NeoProfen is designated chemically as α-methyl-4-(2-methyl propyl) benzeneacetic acid lysine salt.

Its molecular weight is 352.48. Its empirical formula is C 19 H 32 N 2 O 4 . It occurs as a white crystalline solid which is soluble in water and slightly soluble in ethanol.

Chemical Structure

💬 Information for Patients 76 words ▾

17 PATIENT COUNSELING INFORMATION Infection NeoProfen may alter signs of infection. Patients' caregivers should be informed to monitor the infant for any signs of infection. Platelet Aggregation Patients' caregivers should be informed that like other NSAIDS, NeoProfen can inhibit clot formation therefore their infant should be monitored for any signs of bleeding.

Administration Patients' caregivers should be informed that the infants' skin and tissues should be monitored as leakage from administration may be irritating to tissue.

🧬 Pharmacokinetics ~1 min read ▾

12.2Pharmacokinetics and Bioavailability Studies The pharmacokinetic data were obtained from 54 NeoProfen-treated premature infants included in a double-blind, placebo-controlled, randomized, multicenter study. Infants were less than 30 weeks gestational age, weighed between 500 and 1000 g, and exhibited asymptomatic PDA with evidence of echocardiographic documentation of ductal shunting. Dosing was initially 10 mg/kg followed by 5 mg/kg at 24 and 48 hours.

The population average clearance and volume of distribution values of racemic ibuprofen for premature infants at birth were 3 mL/kg/h and 320 mL/kg, respectively. Clearance increased rapidly with post-natal age (an average increase of approximately 0.5 mL/kg/h per day). Inter-individual variability in clearance and volume of distribution were 55% and 14%, respectively.

In general, the half-life in infants is more than 10 times longer than in adults. The metabolism and excretion of ibuprofen in premature infants have not been studied. In adults, renal elimination of unchanged ibuprofen accounts for only 10-15% of the dose.

The excretion of ibuprofen and metabolites occurs rapidly in both urine and feces. Approximately 80% of the dose administered orally is recovered in urine as hydroxyl and carboxyl metabolites, respectively, as a mixture of conjugated and unconjugated forms. Ibuprofen is eliminated primarily by metabolism in the liver where CYP2C9 mediates the 2- and 3-hydroxylations of R- and S-ibuprofen.

Ibuprofen and its metabolites are further conjugated to acyl glucuronides. In neonates, renal function and the enzymes associated with drug metabolism are underdeveloped at birth and substantially increase in the days after birth.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES In a double-blind, multicenter clinical study premature infants of birth weight between 500 and 1000 g, less than 30 weeks post-conceptional age, and with echocardiographic evidence of a PDA were randomized to placebo or NeoProfen. These infants were asymptomatic from their PDA at the time of enrollment. The primary efficacy parameter was the need for rescue therapy (indomethacin, open-label ibuprofen, or surgery) to treat a hemodynamically significant PDA by study day 14.

An infant was rescued if there was clinical evidence of a hemodynamically significant PDA that was echocardiographically confirmed. A hemodynamically significant PDA was defined by three of the following five criteria ― bounding pulse, hyperdynamic precordium, pulmonary edema, increased cardiac silhouette, or systolic murmur ― or hemodynamically significant ductus as determined by a neonatologist. One hundred and thirty-six premature infants received either placebo or NeoProfen (10 mg/kg on the first dose and 5 mg/kg at 24 and 48 hours).

Mean birth age was 1.5 days (range: 4.6 – 73.0 hours), mean gestational age was 26 weeks (range: 23 – 30 weeks), and mean weight was 798 g (range: 530 – 1015 g). All infants had a documented PDA with evidence of ductal shunting. As shown in Table 2, 25% of infants on NeoProfen required rescue therapy versus 48% of infants on placebo (p=0.003 from logistic regression controlling for site).

Table 2. Summary of Efficacy Results, n (%) NeoProfen Placebo N=68 N=68 Required rescue through study day 14 Total 17 (25) 33 (48) By age at treatment Birth to < 24 hours 3/14 (21) 8/16 (50) 24-48 hours 9/32 (28) 16/37 (43) > 48 hours 5/22 (23) 9/15 (60) Echocardiographically proven PDA prior to rescue 17 (100) 32 (97) Reasons for Rescue Hemodynamically significant PDA per neonatologist 14 (82) 25 (76) Bounding pulse 6 (35) 12 (36) Systolic murmur 6 (35) 15 (45) Pulmonary Edema 3 (18) 5 (15) Hyperdynamic precordium 2 (12) 3 (9) Increased cardiac silhouette 1 (6) 5 (15) Of the infants requiring rescue within the first 14 days after the first dose of study drug, no statistically significant difference was observed between the NeoProfen and placebo groups for mean age at start of first rescue treatment (8.7 days, range 4-15 days, for the NeoProfen group and 6.9 days, range 2-15 days, for the placebo group).

The groups were similar in the number of deaths by day 14, the number of patients on a ventilator or requiring oxygenation at day 1, 4 and 14, the number of patients requiring surgical ligation of their PDA (12%), the number of cases of Pulmonary Hemorrhage and Pulmonary Hypertension by day 14, and Bronchopulmonary Dysplasia at day 28. In addition, no significant differences were noted in the incidences of Stage 2 and 3 Necrotizing Enterocolitis, Grades 3 and 4 Intraventricular Hemorrhage, Periventricular Leukomalacia and Retinopathy of Prematurity between groups as determined at 36±1 weeks adjusted gestational age.

Two supportive studies also determined that ibuprofen, either prophylactically (n=433, weight range: 400 – 2165 g) or as treatment (n=210, weight range: 400 – 2370 g), was superior to placebo (or no treatment) in preventing the need for rescue therapy for a symptomatic PDA.

📄 Recent Major Changes 7 words ▾

Warnings and Precautions ( 5.6 ) 10/2023

📄 Package Label / Principal Display Panel 44 words ▾

PRINCIPAL DISPLAY PANEL - 2 mL Vial Carton NDC 55292-122-52 3 x 2 mL Single Dose Vials NeoProfen ® (ibuprofen lysine) injection 20mg/2mL (10mg/mL) Sterile Solution for Intravenous Use Only RECORDATI RARE DISEASES GROUP Rx only PRINCIPAL DISPLAY PANEL - 2 mL Vial Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for NEOPROFEN (this brand).

Top reported reactions

Bronchopulmonary Dysplasia113
Intraventricular Haemorrhage34
Necrotising Colitis30
Gastrointestinal Perforation29
Completed Suicide27
Anaemia25
Hyponatraemia25

Age at onset

Neonate15
Infant12
Adolescent2
Adult15
Elderly2

Reporter sex

0 reports
Male · 43%
Female · 43%
Unknown · 13%

Serious outcomes

Hospitalization134
Death94
Disabling48
Life-threatening37
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 55 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Recordati Rare Diseases Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Recordati Rare Diseases Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 55289-0995-07 · PD-Rx 55292-0131-60 · Recordati →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.