Over-the-counter drug · NDA
Childrens MOTRIN (Ibuprofen) NDC 50580-601
Ibuprofen 100 mg/5mL · Suspension · Oral · Kenvue Brands LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50580-601-08 | 5058006010850580060108 | 2 CARTON in 1 PACKAGE (50580-601-08) / 1 BOTTLE, PLASTIC in 1 CARTON (50580-601-04) / 120 mL in 1 BOTTLE, PLASTICMarketed from Jan 30, 2002 | |
| 50580-601-20 | 5058006012050580060120 | 1 BOTTLE, PLASTIC in 1 CARTON (50580-601-20) / 120 mL in 1 BOTTLE, PLASTICMarketed from Mar 1, 2012 | |
| 50580-601-21 | 5058006012150580060121 | 1 BOTTLE, PLASTIC in 1 CARTON (50580-601-21) / 120 mL in 1 BOTTLE, PLASTICMarketed from Mar 1, 2012 | |
| 50580-601-22 | 5058006012250580060122 | 1 BOTTLE, PLASTIC in 1 CARTON (50580-601-22) / 30 mL in 1 BOTTLE, PLASTICMarketed from Mar 1, 2012 | |
| 50580-601-25 | 5058006012550580060125 | 2 CARTON in 1 PACKAGE (50580-601-25) / 1 BOTTLE, PLASTIC in 1 CARTON / 120 mL in 1 BOTTLE, PLASTICMarketed from Jul 10, 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)
- Childrens MOTRIN
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 100 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Kenvue Brands LLCNDC labeler code 50580
- 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 50580-601_22ebcf8b-8b39-47f7-e063-6394a90a735bSPL ID 22ebcf8b-8b39-47f7-e063-6394a90a735bSPL set ID f2609308-17bf-4bcb-84b2-d17f3fd35958RxCUI 197803, 544393UNII WK2XYI10QMUPC 0300450192011
- 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
N450580060108followed by a unit qualifier and the quantityPackage 50580-0601-08. 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.
About NDC 50580-601
- What is NDC 50580-601?
- 50580-601 is the product NDC for Childrens MOTRIN (ibuprofen), Ibuprofen 100 mg/5mL suspension, listed with the FDA by Kenvue Brands LLC. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Childrens MOTRIN (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 Childrens MOTRIN?
- 5 other product NDCs are listed under this name. See all Childrens MOTRIN NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Childrens MOTRIN products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Childrens Motrinibuprofen | Ibuprofen 100 mg/1 | Tablet, ChewableOral | Kenvue Brands LLC | 50580-932 | 50580-0932-01 |
| Childrens Motrinibuprofen | Ibuprofen 100 mg/1 | Tablet, ChewableOral | Kenvue Brands LLC | 50580-933 | 50580-0933-01 |
| Childrens Motrinibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Kenvue Brands LLC | 50580-603 | 50580-0603-04 |
| Childrens Motrinibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Kenvue Brands LLC | 50580-604 | 50580-0604-04 |
| Childrens Motrinibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Kenvue Brands LLC | 50580-184 | 50580-0184-0150580-0184-5050580-0184-52 |
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 | 50580-184 |
| Childrens Motrinibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Kenvue Brands LLC | 50580-603 |
| Childrens Motrinibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Kenvue Brands LLC | 50580-604 |