NDC codes

FDA NDC Directory
Product NDC (as listed)0573-0191Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00573-0191Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0573-0191-20005730191201 BOTTLE, DROPPER in 1 CARTON (0573-0191-20) / 15 mL in 1 BOTTLE, DROPPERMarketed from Jan 30, 1998
0573-0191-22005730191221 BOTTLE, DROPPER in 1 CARTON (0573-0191-22) / 15 mL in 1 BOTTLE, DROPPERMarketed from Jan 30, 2014
0573-0191-50005730191501 BOTTLE, DROPPER in 1 CARTON (0573-0191-50) / 30 mL in 1 BOTTLE, DROPPERMarketed from Jan 30, 1998
0573-0191-75005730191751 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

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

N400573019120 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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