NDC codes

FDA NDC Directory
Product NDC (as listed)50580-198Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50580-0198Add 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 NDC11-digit (billing)PackageCopy
50580-198-05505800198051 BOTTLE in 1 CARTON (50580-198-05) / 15 mL in 1 BOTTLEMarketed from Jun 8, 2026
50580-198-50505800198501 BOTTLE in 1 CARTON (50580-198-50) / 30 mL in 1 BOTTLEMarketed from Jun 8, 2012

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)
Motrin InfantsSuffix: Infants
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 50 mg/1.25mL
Dosage form
Suspension/ drops
Route
Oral
Labeler
Kenvue Brands LLCNDC labeler code 50580
Product type
Over-the-counter drug
Marketing category
NDA — New Drug ApplicationApplication NDA 020603
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 50580-198_519a1a5f-e816-0d56-e063-6294a90a337dSPL ID 519a1a5f-e816-0d56-e063-6294a90a337dSPL set ID c57f6ded-c0bd-45ae-823a-4c02ce334d98RxCUI 204442, 854762UNII WK2XYI10QMUPC 0300450198167

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N450580019805 followed by a unit qualifier and the quantity

Package 50580-0198-05. 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 .

Indications (excerpt from the label)

Uses temporarily: reduces fever relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50580-198

What is NDC 50580-198?
50580-198 is the product NDC for Motrin Infants (ibuprofen), Ibuprofen 50 mg/1.25mL suspension/ drops, listed with the FDA by Kenvue Brands LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Motrin Infants (Ibuprofen).
What is the active ingredient?
Ibuprofen.
Who is the labeler?
Kenvue Brands LLC, NDC labeler code 50580. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Motrin Infants?
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 020603

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

FDA NDC Directory listings under NDA 020603
ProductStrengthForm · routeLabelerProduct NDC
Infants MotrinibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralKenvue Brands LLC50580-100

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