Over-the-counter drug · ANDA
IBUPROFEN Infants (Ibuprofen) NDC 51672-2146
Ibuprofen 50 mg/1.25mL · Suspension/ drops · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-2146-3 | 51672214603 | 1 BOTTLE in 1 CARTON (51672-2146-3) / 30 mL in 1 BOTTLEMarketed from Aug 8, 2023 | |
| 51672-2146-5 | 51672214605 | 1 BOTTLE in 1 CARTON (51672-2146-5) / 15 mL in 1 BOTTLEMarketed from Dec 3, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 InfantsSuffix: Infants
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 50 mg/1.25mL
- Dosage form
- Suspension/ drops
- Route
- Oral
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 51672
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217261
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 51672-2146_4db5c2e1-85e1-4689-e063-6294a90aaf91SPL ID 4db5c2e1-85e1-4689-e063-6294a90aaf91SPL set ID bc816597-a85a-4143-9f99-bb0699ca57c5RxCUI 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
N451672214603followed by a unit qualifier and the quantityPackage 51672-2146-03. 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: 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 51672-2146
- What is NDC 51672-2146?
- 51672-2146 is the product NDC for IBUPROFEN Infants (ibuprofen), Ibuprofen 50 mg/1.25mL suspension/ drops, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- IBUPROFEN Infants (Ibuprofen).
- What is the active ingredient?
- Ibuprofen.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 51672. 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?
- 2 other product NDCs are listed under this name. See all IBUPROFEN Infants NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other IBUPROFEN Infants products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| ibuprofen infantsibuprofen | Ibuprofen 50 mg/1.25mL | SuspensionOral | H E B | 37808-057 | 37808-0057-05 |
| ibuprofen infantsibuprofen | Ibuprofen 50 mg/1.25mL | SuspensionOral | HyVee Inc | 42507-057 | 42507-0057-05 |