Over-the-counter drug · ANDA
Ibuprofen infants Drops (Ibuprofen) NDC 69256-687
Ibuprofen 50 mg/1.25mL · Suspension/ drops · Oral · Harris Teeter, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69256-687-09 | 6925606870969256068709 | 1 BOTTLE in 1 CARTON (69256-687-09) / 30 mL in 1 BOTTLEMarketed from Jan 29, 2025 |
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)
- Ibuprofen infants Drops
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 50 mg/1.25mL
- Dosage form
- Suspension/ drops
- Route
- Oral
- Labeler
- Harris Teeter, LLCNDC labeler code 69256
- 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 69256-687_24638320-f647-4dff-954c-8ae49197746aSPL ID 24638320-f647-4dff-954c-8ae49197746aSPL set ID 2c39a24f-4e42-d75f-e063-6394a90a60faRxCUI 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
N469256068709followed by a unit qualifier and the quantityPackage 69256-0687-09. 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.
About NDC 69256-687
- What is NDC 69256-687?
- 69256-687 is the product NDC for Ibuprofen infants Drops (ibuprofen), Ibuprofen 50 mg/1.25mL suspension/ drops, listed with the FDA by Harris Teeter, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ibuprofen infants Drops (Ibuprofen).
- What is the active ingredient?
- Ibuprofen.
- Who is the labeler?
- Harris Teeter, LLC, NDC labeler code 69256. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ibuprofen infants Drops?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 |
| Concentrated ibuprofen infantsibuprofen | Ibuprofen 50 mg/1.25mL | Suspension/ dropsOral | Guardian Drug Company | 53041-637 |
| Concentrated ibuprofen infantsibuprofen | Ibuprofen 50 mg/1.25mL | Suspension/ dropsOral | Chain Drug Marketing Association Inc. | 83324-005 |
| Infants Ibuprofen | Ibuprofen 50 mg/1.25mL | Suspension/ dropsOral | Family Dollar Services, Inc. | 55319-637 |