Concentrated ibuprofen infants (ibuprofen) NDC 83324-005

NDC codes

FDA NDC Directory

Product NDC (as listed)83324-005Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83324-0005Add 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 NDC	11-digit (billing)	Package	Copy
83324-005-30	83324000530	1 BOTTLE in 1 CARTON (83324-005-30) / 30 mL in 1 BOTTLEMarketed from Nov 3, 2023

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): Concentrated ibuprofen infants
Generic name (nonproprietary): ibuprofen
Active ingredients: Ibuprofen — 50 mg/1.25mL
Dosage form: Suspension/ drops
Route: Oral
Labeler: Chain Drug Marketing Association Inc.
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210755
Marketing start: Nov 3, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 83324-005_c9ae72d8-d205-4736-9bc4-2325cd77d36bSPL ID c9ae72d8-d205-4736-9bc4-2325cd77d36bSPL set ID c9ae72d8-d205-4736-9bc4-2325cd77d36bRxCUI 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

N483324000530 followed by a unit qualifier and the quantity

Package 83324-0005-30. 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 Nov 3, 2023.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210755

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 210755
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	Guardian Drug Company	53041-637
Infants Ibuprofen	Ibuprofen 50 mg/1.25mL	Suspension/ dropsOral	Family Dollar Services, Inc.	55319-637