Over-the-counter drug · ANDA
Childrens Ibuprofen (Ibuprofen) NDC 0363-8901
Ibuprofen 100 mg/5mL · Suspension · Oral · WALGREEN CO.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-8901-24 | 0036389012400363890124 | 1 BOTTLE in 1 CARTON (0363-8901-24) / 120 mL in 1 BOTTLEMarketed from Jan 11, 2024 | |
| 0363-8901-37 | 0036389013700363890137 | 2 BOTTLE in 1 CARTON (0363-8901-37) / 120 mL in 1 BOTTLEMarketed from Jan 11, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- WALGREEN CO.NDC labeler code 0363
- 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 0363-8901_f3fc1688-5031-4909-85e3-066820f29f2aSPL ID f3fc1688-5031-4909-85e3-066820f29f2aSPL set ID fea3c4b2-cf96-2425-e053-6394a90ac697RxCUI 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
N400363890124followed by a unit qualifier and the quantityPackage 00363-8901-24. 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 0363-8901
- What is NDC 0363-8901?
- 0363-8901 is the product NDC for Childrens Ibuprofen (ibuprofen), Ibuprofen 100 mg/5mL suspension, listed with the FDA by WALGREEN CO.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Childrens Ibuprofen (Ibuprofen).
- What is the active ingredient?
- Ibuprofen.
- Who is the labeler?
- WALGREEN CO., NDC labeler code 0363. 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 Ibuprofen?
- 54 other product NDCs are listed under this name. See all Childrens Ibuprofen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Childrens 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) |
|---|---|---|---|---|---|
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Amazon.com Services LLC | 72288-392 | 72288-0392-34 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/1 | Tablet, ChewableOral | Amazon.com Services LLC | 72288-320 | 72288-0320-62 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Advagen Pharma Ltd. | 72888-479 | 72888-0479-01 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Preferred Pharmaceuticals Inc. | 68788-4031 | 68788-4031-01 |
| childrens ibuprofenibuprofen | Ibuprofen 100 mg/1 | Tablet, ChewableOral | Safeway | 21130-790 | 21130-0790-62 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Safeway | 21130-506 | 21130-0506-26 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/1 | Tablet, ChewableOral | Meijer, Inc. | 79481-0419 | 79481-0419-00 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Safeway | 21130-510 | 21130-0510-26 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Better Living Brands, LLC | 21130-216 | 21130-0216-20 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | Suspension/ dropsOral | Discount Drug Mart, Inc | 53943-682 | 53943-0682-03 |
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 | Randob Labs., Ltd. | 52412-911 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | KROGER COMPANY | 30142-281 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Aurohealth LLC | 58602-002 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Aurohealth LLC | 58602-003 |
| 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 | Better Living Brands, LLC | 21130-216 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | 7-Eleven | 10202-150 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | 7-Eleven | 10202-711 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Chalkboard Health | 79395-003 |
| Childrens FLANAX ORALibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Belmora LLC | 27854-777 |