What is NDC 55292-122?

55292-122 is the product NDC for Neoprofen (ibuprofen lysine), Ibuprofen lysine 10 mg/mL solution, listed with the FDA by Recordati Rare Diseases Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Recordati Rare Diseases Inc., NDC labeler code 55292. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Neoprofen?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Neoprofen NDC 55292-122 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)55292-122Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55292-0122Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
55292-122-52	55292012252	3 VIAL in 1 CARTON (55292-122-52) / 2 mL in 1 VIALMarketed from Apr 13, 2006

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Neoprofen
Generic name (nonproprietary): ibuprofen lysine
Active ingredients: Ibuprofen lysine — 10 mg/mL
Dosage form: Solution
Route: Intravenous
Labeler: Recordati Rare Diseases Inc.NDC labeler code 55292
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021903
Marketing start: Apr 13, 2006
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 55292-122_5b563933-e1a3-418c-a1fd-0433d1d9233fSPL ID 5b563933-e1a3-418c-a1fd-0433d1d9233fSPL set ID 6f5ede6f-b0b7-4fc8-969e-652f60ead047RxCUI 637197, 1747294UNII N01ORX9D6S
Pharmacologic class: Nonsteroidal Anti-inflammatory Drug

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N455292012252 followed by a unit qualifier and the quantity

Package 55292-0122-52. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Oct 15, 2024.

Indications (excerpt from the 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. 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 inf…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55292-122

What is NDC 55292-122?: 55292-122 is the product NDC for Neoprofen (ibuprofen lysine), Ibuprofen lysine 10 mg/mL solution, listed with the FDA by Recordati Rare Diseases Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Neoprofen (Ibuprofen lysine).
What is the active ingredient?: Ibuprofen lysine.
Who is the labeler?: Recordati Rare Diseases Inc., NDC labeler code 55292. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Neoprofen?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under NDA 021903

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021903
Product	Strength	Form · route	Labeler	Product NDC
Ibuprofen Lysine	Ibuprofen lysine 10 mg/mL	SolutionIntravenous	Prasco Laboratories	66993-490

Neoprofen (Ibuprofen lysine) NDC 55292-122