Over-the-counter drug · ANDA
Childrens Ibuprofen (ibuprofen) NDC 58602-003
Ibuprofen 100 mg/5mL · Suspension · Oral · Aurohealth LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-003-20 | 58602000320 | 1 BOTTLE in 1 CARTON (58602-003-20) / 240 mL in 1 BOTTLEMarketed from Jun 16, 2021 | |
| 58602-003-24 | 58602000324 | 1 BOTTLE in 1 CARTON (58602-003-24) / 120 mL in 1 BOTTLEMarketed from Jun 16, 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 Ibuprofen
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 100 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Aurohealth LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209179
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 58602-003_317fdce4-a082-4e9a-85b8-380ab68a6631SPL ID 317fdce4-a082-4e9a-85b8-380ab68a6631SPL set ID 0e1bcb06-be48-4efc-82e2-516582e02348RxCUI 197803UNII 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
N458602000320followed by a unit qualifier and the quantityPackage 58602-0003-20. 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 ANDA 209179
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 Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Aurohealth LLC | 58602-002 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Aurohealth LLC | 58602-008 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | BluePoint Laboratories | 68001-521 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | 7-Eleven | 10202-150 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Chalkboard Health | 79395-003 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | 7-Eleven | 10202-711 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | KROGER COMPANY | 30142-281 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Randob Labs., Ltd. | 52412-911 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Better Living Brands, LLC | 21130-216 |
| Childrens FLANAX ORALibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Belmora LLC | 27854-777 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | WALGREEN CO. | 0363-8901 |