Over-the-counter drug · NDA
Childrens Motrin (ibuprofen) NDC 50580-184
Ibuprofen 100 mg/5mL · Suspension · Oral · Kenvue Brands LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50580-184-01 | 50580018401 | 1 BOTTLE, PLASTIC in 1 CARTON (50580-184-01) / 240 mL in 1 BOTTLE, PLASTICMarketed from Dec 27, 2021 | |
| 50580-184-50 | 50580018450 | 1 BOTTLE, PLASTIC in 1 CARTON (50580-184-50) / 120 mL in 1 BOTTLE, PLASTICMarketed from Feb 28, 2012 | |
| 50580-184-52 | 50580018452 | 3 CARTON in 1 PACKAGE (50580-184-52) / 1 BOTTLE, PLASTIC in 1 CARTON / 120 mL in 1 BOTTLE, PLASTICMarketed from May 3, 2021 |
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)
- Childrens Motrin
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 100 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Kenvue Brands LLC
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020516
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 50580-184_21d440bd-8a6a-5109-e063-6394a90a0e8fSPL ID 21d440bd-8a6a-5109-e063-6394a90a0e8fSPL set ID 9e1cdef7-921f-4163-869c-6c062e31c5bbRxCUI 197803, 544393UNII WK2XYI10QMUPC 0300450184047
- 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
N450580018401followed by a unit qualifier and the quantityPackage 50580-0184-01. 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: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020516
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 |
|---|---|---|---|---|
| Childrens Motrinibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Kenvue Brands LLC | 50580-604 |
| Childrens MOTRINibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Kenvue Brands LLC | 50580-601 |
| Childrens Motrinibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Kenvue Brands LLC | 50580-603 |