Over-the-counter drug · ANDA
Infants Ibuprofen (Ibuprofen) NDC 58602-227
Ibuprofen 50 mg/1.25mL · Suspension · Oral · Aurohealth LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-227-04 | 5860202270458602022704 | 1 BOTTLE in 1 CARTON (58602-227-04) / 15 mL in 1 BOTTLEMarketed from Apr 8, 2024 | |
| 58602-227-07 | 5860202270758602022707 | 1 BOTTLE in 1 CARTON (58602-227-07) / 30 mL in 1 BOTTLEMarketed from Apr 8, 2024 |
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)
- Infants Ibuprofen
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 50 mg/1.25mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Aurohealth LLCNDC labeler code 58602
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213506
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 58602-227_2a48af51-23e2-4fec-a76b-eef1611750f5SPL ID 2a48af51-23e2-4fec-a76b-eef1611750f5SPL set ID 2a48af51-23e2-4fec-a76b-eef1611750f5RxCUI 204442UNII WK2XYI10QM
- 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
N458602022704followed by a unit qualifier and the quantityPackage 58602-0227-04. 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 58602-227
- What is NDC 58602-227?
- 58602-227 is the product NDC for Infants Ibuprofen (ibuprofen), Ibuprofen 50 mg/1.25mL suspension, listed with the FDA by Aurohealth LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Infants Ibuprofen (Ibuprofen).
- What is the active ingredient?
- Ibuprofen.
- Who is the labeler?
- Aurohealth LLC, NDC labeler code 58602. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Infants Ibuprofen?
- 6 other product NDCs are listed under this name. See all Infants Ibuprofen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Infants Ibuprofen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Infants Ibuprofenibuprofen | Ibuprofen 50 mg/1.25mL | Suspension/ dropsOral | Amazon.com Services LLC | 72288-770 | 72288-0770-10 |
| Infants Ibuprofenibuprofen | Ibuprofen 50 mg/1.25mL | Suspension/ dropsOral | Safeway | 21130-513 | 21130-0513-10 |
| Infants Ibuprofen | Ibuprofen 50 mg/1.25mL | Suspension/ dropsOral | Family Dollar Services, Inc. | 55319-637 | 55319-0637-09 |
| infants ibuprofenibuprofen | Ibuprofen 50 mg/1.25mL | Suspension/ dropsOral | Walgreen Company | 0363-8139 | 00363-8139-10 |
| Infants Ibuprofenibuprofen | Ibuprofen 50 mg/1.25mL | SuspensionOral | Walgreens | 0363-5100 | 00363-5100-01 |
| infants ibuprofenibuprofen | Ibuprofen 50 mg/1.25mL | Suspension/ dropsOral | H E B | 37808-255 | 37808-0255-10 |