Over-the-counter drug · NDA
Infants Advil (Ibuprofen) NDC 0573-0191
Ibuprofen 50 mg/1.25mL · Suspension/ drops · Oral · Haleon US Holdings LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0573-0191-20 | 00573019120 | 1 BOTTLE, DROPPER in 1 CARTON (0573-0191-20) / 15 mL in 1 BOTTLE, DROPPERMarketed from Jan 30, 1998 | |
| 0573-0191-22 | 00573019122 | 1 BOTTLE, DROPPER in 1 CARTON (0573-0191-22) / 15 mL in 1 BOTTLE, DROPPERMarketed from Jan 30, 2014 | |
| 0573-0191-50 | 00573019150 | 1 BOTTLE, DROPPER in 1 CARTON (0573-0191-50) / 30 mL in 1 BOTTLE, DROPPERMarketed from Jan 30, 1998 | |
| 0573-0191-75 | 00573019175 | 1 BOTTLE, DROPPER in 1 CARTON (0573-0191-75) / 22.5 mL in 1 BOTTLE, DROPPERMarketed from Jan 30, 1998 |
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)
- Infants Advil
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 50 mg/1.25mL
- Dosage form
- Suspension/ drops
- Route
- Oral
- Labeler
- Haleon US Holdings LLCNDC labeler code 0573
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020812
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 0573-0191_9f156faa-6bf8-483c-837d-050e40ec0cc5SPL ID 9f156faa-6bf8-483c-837d-050e40ec0cc5SPL set ID db5ed801-7a7e-3c83-0172-77f914daaa5aRxCUI 204442, 731531UNII 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
N400573019120followed by a unit qualifier and the quantityPackage 00573-0191-20. 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, headaches and toothaches
Excerpt only. Read the full label for complete information.
About NDC 0573-0191
- What is NDC 0573-0191?
- 0573-0191 is the product NDC for Infants Advil (ibuprofen), Ibuprofen 50 mg/1.25mL suspension/ drops, listed with the FDA by Haleon US Holdings LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Infants Advil (Ibuprofen).
- What is the active ingredient?
- Ibuprofen.
- Who is the labeler?
- Haleon US Holdings LLC, NDC labeler code 0573. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Infants Advil?
- 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.