Concentrated ibuprofen infants (ibuprofen) NDC 49035-635

NDC codes

FDA NDC Directory

Product NDC (as listed)49035-635Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49035-0635Add 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
49035-635-09	49035063509	1 BOTTLE in 1 CARTON (49035-635-09) / 30 mL in 1 BOTTLEMarketed from Jun 20, 2019

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: Wal-Mart Stores, Inc.
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210755
Marketing start: Jun 20, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 49035-635_ad449225-ed60-4c66-9fd6-34bef9a4b42eSPL ID ad449225-ed60-4c66-9fd6-34bef9a4b42eSPL set ID 00b7fc71-8cf0-4c12-a479-146408f7f91bRxCUI 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

N449035063509 followed by a unit qualifier and the quantity

Package 49035-0635-09. 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 Jan 11, 2022.

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
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	Chain Drug Marketing Association Inc.	83324-005
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