Over-the-counter drug · ANDA
Childrens Ibuprofen (ibuprofen) NDC 83324-013
Ibuprofen 100 mg/5mL · Suspension/ drops · Oral · Chain Drug Marketing Association Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83324-013-04 | 83324001304 | 1 BOTTLE in 1 CARTON (83324-013-04) / 120 mL in 1 BOTTLEMarketed from Nov 10, 2023 |
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/ drops
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210149
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 83324-013_c7e59784-a338-4922-a806-98c7505957cdSPL ID c7e59784-a338-4922-a806-98c7505957cdSPL set ID c7e59784-a338-4922-a806-98c7505957cdRxCUI 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
N483324001304followed by a unit qualifier and the quantityPackage 83324-0013-04. 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)
USE(S) 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 210149
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 Ibuprofen bubblegumibuprofen | Ibuprofen 100 mg/5mL | Suspension/ dropsOral | Guardian Drug Company | 53041-572 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | Suspension/ dropsOral | Guardian Drug Company | 53041-634 |
| Childrens Ibuprofen fruitibuprofen | Ibuprofen 100 mg/5mL | Suspension/ dropsOral | Guardian Drug Company | 53041-632 |
| Childrens Ibuprofen 572ibuprofen | Ibuprofen 100 mg/5mL | Suspension/ dropsOral | Family Dollar Services, Inc. | 55319-929 |
| Childrens Ibuprofen blue raspberryibuprofen | Ibuprofen 100 mg/5mL | Suspension/ dropsOral | Guardian Drug Company | 53041-638 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Harris Teeter, LLC | 69256-634 |
| Childrens Ibuprofen grapeibuprofen | Ibuprofen 100 mg/5mL | Suspension/ dropsOral | Guardian Drug Company | 53041-639 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | Suspension/ dropsOral | Chain Drug Marketing Association Inc. | 83324-014 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | Suspension/ dropsOral | Chain Drug Marketing Association Inc. | 83324-012 |
| Dye Free Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | CVS | 51316-914 |
| Childrens Ibuprofen Bubblegum Dye Freeibuprofen | Ibuprofen 100 mg/5mL | Suspension/ dropsOral | CVS | 51316-932 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | Suspension/ dropsOral | Family Dollar Services, Inc. | 55319-114 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | Suspension/ dropsOral | Discount Drug Mart, Inc | 53943-682 |