Over-the-counter drug · ANDA
Infants Ibuprofen NDC 55319-637
Ibuprofen 50 mg/1.25mL · Suspension/ drops · Oral · Family Dollar Services, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55319-637-09 | 55319063709 | 1 BOTTLE in 1 CARTON (55319-637-09) / 30 mL in 1 BOTTLEMarketed from Mar 27, 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)
- infants ibuprofen
- Active ingredients
- Ibuprofen — 50 mg/1.25mL
- Dosage form
- Suspension/ drops
- Route
- Oral
- Labeler
- Family Dollar Services, Inc.
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210755
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 55319-637_e1e7c996-307e-41d3-a1f2-a1f2c6567f8dSPL ID e1e7c996-307e-41d3-a1f2-a1f2c6567f8dSPL set ID 13143eb6-2fe8-487b-e063-6294a90a967eRxCUI 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
N455319063709followed by a unit qualifier and the quantityPackage 55319-0637-09. 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: 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.
Other NDCs under ANDA 210755
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 |
|---|---|---|---|---|
| Concentrated ibuprofen infantsibuprofen | Ibuprofen 50 mg/1.25mL | Suspension/ dropsOral | Wal-Mart Stores, Inc. | 49035-635 |
| Ibuprofen infants Dropsibuprofen | Ibuprofen 50 mg/1.25mL | Suspension/ dropsOral | Harris Teeter, LLC | 69256-687 |
| Concentrated ibuprofen infantsibuprofen | Ibuprofen 50 mg/1.25mL | Suspension/ dropsOral | Chain Drug Marketing Association Inc. | 83324-005 |
| Concentrated ibuprofen infantsibuprofen | Ibuprofen 50 mg/1.25mL | Suspension/ dropsOral | Guardian Drug Company | 53041-637 |