Childrens Ibuprofen fruit (ibuprofen) NDC 53041-632

NDC codes

FDA NDC Directory

Product NDC (as listed)53041-632Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53041-0632Add 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
53041-632-03	53041063203	1 BOTTLE in 1 CARTON (53041-632-03) / 120 mL in 1 BOTTLEMarketed from Oct 13, 2021
53041-632-04	53041063204	1 BOTTLE in 1 CARTON (53041-632-04) / 240 mL in 1 BOTTLEMarketed from Oct 13, 2021

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): Childrens Ibuprofen fruit
Generic name (nonproprietary): ibuprofen
Active ingredients: Ibuprofen — 100 mg/5mL
Dosage form: Suspension/ drops
Route: Oral
Labeler: Guardian Drug Company
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210149
Marketing start: Oct 13, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 53041-632_e690a788-b856-44b3-afff-bb950d1eb117SPL ID e690a788-b856-44b3-afff-bb950d1eb117SPL set ID 9cb92af9-a829-4f54-b8f5-4e5cb4f165b7RxCUI 197803UNII 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

N453041063203 followed by a unit qualifier and the quantity

Package 53041-0632-03. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 210149

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

FDA NDC Directory listings under ANDA 210149
Product	Strength	Form · route	Labeler	Product NDC
Childrens Ibuprofen bubblegumibuprofen	Ibuprofen 100 mg/5mL	Suspension/ dropsOral	Guardian Drug Company	53041-572
Childrens Ibuprofenibuprofen	Ibuprofen 100 mg/5mL	Suspension/ dropsOral	Guardian Drug Company	53041-634
Childrens Ibuprofen 572ibuprofen	Ibuprofen 100 mg/5mL	Suspension/ dropsOral	Family Dollar Services, Inc.	55319-929
Childrens Ibuprofen blue raspberryibuprofen	Ibuprofen 100 mg/5mL	Suspension/ dropsOral	Guardian Drug Company	53041-638
Childrens Ibuprofenibuprofen	Ibuprofen 100 mg/5mL	SuspensionOral	Harris Teeter, LLC	69256-634
Childrens Ibuprofen grapeibuprofen	Ibuprofen 100 mg/5mL	Suspension/ dropsOral	Guardian Drug Company	53041-639
Childrens Ibuprofenibuprofen	Ibuprofen 100 mg/5mL	Suspension/ dropsOral	Chain Drug Marketing Association Inc.	83324-014
Childrens Ibuprofenibuprofen	Ibuprofen 100 mg/5mL	Suspension/ dropsOral	Chain Drug Marketing Association Inc.	83324-012
Childrens Ibuprofenibuprofen	Ibuprofen 100 mg/5mL	Suspension/ dropsOral	Chain Drug Marketing Association Inc.	83324-013
Dye Free Childrens Ibuprofenibuprofen	Ibuprofen 100 mg/5mL	SuspensionOral	CVS	51316-914
Childrens Ibuprofen Bubblegum Dye Freeibuprofen	Ibuprofen 100 mg/5mL	Suspension/ dropsOral	CVS	51316-932
Childrens Ibuprofenibuprofen	Ibuprofen 100 mg/5mL	Suspension/ dropsOral	Family Dollar Services, Inc.	55319-114
Childrens Ibuprofenibuprofen	Ibuprofen 100 mg/5mL	Suspension/ dropsOral	Discount Drug Mart, Inc	53943-682