What is NDC 55319-637?

55319-637 is the product NDC for Infants Ibuprofen, Ibuprofen 50 mg/1.25mL suspension/ drops, listed with the FDA by Family Dollar Services, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Family Dollar Services, Inc., NDC labeler code 55319. 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 Ibuprofen?

6 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Infants Ibuprofen NDC 55319-637 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)55319-637Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55319-0637Add 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
55319-637-09	5531906370955319063709	1 BOTTLE in 1 CARTON (55319-637-09) / 30 mL in 1 BOTTLEMarketed from Mar 27, 2024

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): Infants Ibuprofen
Generic name (nonproprietary): infants ibuprofen
Active ingredients: Ibuprofen — 50 mg/1.25mL
Dosage form: Suspension/ drops
Route: Oral
Labeler: Family Dollar Services, Inc.NDC labeler code 55319
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210755
Marketing start: Mar 27, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 55319-637_e1e7c996-307e-41d3-a1f2-a1f2c6567f8dSPL ID e1e7c996-307e-41d3-a1f2-a1f2c6567f8dSPL set ID 13143eb6-2fe8-487b-e063-6294a90a967eRxCUI 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

N455319063709 followed by a unit qualifier and the quantity

Package 55319-0637-09. 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 Mar 27, 2024.

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)

About NDC 55319-637

What is NDC 55319-637?: 55319-637 is the product NDC for Infants Ibuprofen, Ibuprofen 50 mg/1.25mL suspension/ drops, listed with the FDA by Family Dollar Services, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Infants Ibuprofen.
What is the active ingredient?: Ibuprofen.
Who is the labeler?: Family Dollar Services, Inc., NDC labeler code 55319. 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 Ibuprofen?: 6 other product NDCs are listed under this name. See all Infants Ibuprofen NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Infants Ibuprofen NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Infants Ibuprofenibuprofen	Ibuprofen 50 mg/1.25mL	Suspension/ dropsOral	Amazon.com Services LLC	72288-770	72288-0770-10
Infants Ibuprofenibuprofen	Ibuprofen 50 mg/1.25mL	Suspension/ dropsOral	Safeway	21130-513	21130-0513-10
Infants Ibuprofenibuprofen	Ibuprofen 50 mg/1.25mL	SuspensionOral	Aurohealth LLC	58602-227	58602-0227-0458602-0227-07
infants ibuprofenibuprofen	Ibuprofen 50 mg/1.25mL	Suspension/ dropsOral	Walgreen Company	0363-8139	00363-8139-10
Infants Ibuprofenibuprofen	Ibuprofen 50 mg/1.25mL	SuspensionOral	Walgreens	0363-5100	00363-5100-01
infants ibuprofenibuprofen	Ibuprofen 50 mg/1.25mL	Suspension/ dropsOral	H E B	37808-255	37808-0255-10

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
Concentrated ibuprofen infantsibuprofen	Ibuprofen 50 mg/1.25mL	Suspension/ dropsOral	Guardian Drug Company	53041-637
Concentrated ibuprofen infantsibuprofen	Ibuprofen 50 mg/1.25mL	Suspension/ dropsOral	Chain Drug Marketing Association Inc.	83324-005
Ibuprofen infants Dropsibuprofen	Ibuprofen 50 mg/1.25mL	Suspension/ dropsOral	Harris Teeter, LLC	69256-687