Over-the-counter drug · NDA
Motrin Infants (Ibuprofen) NDC 50580-198
Ibuprofen 50 mg/1.25mL · Suspension/ drops · Oral · Kenvue Brands LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50580-198-05 | 50580019805 | 1 BOTTLE in 1 CARTON (50580-198-05) / 15 mL in 1 BOTTLEMarketed from Jun 8, 2026 | |
| 50580-198-50 | 50580019850 | 1 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
- 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 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
N450580019805followed by a unit qualifier and the quantityPackage 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.
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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Infants Motrinibuprofen | Ibuprofen 50 mg/1.25mL | Suspension/ dropsOral | Kenvue Brands LLC | 50580-100 |