Childrens Zyrtec (cetirizine hydrochloride) NDC 50580-730

NDC codes

FDA NDC Directory

Product NDC (as listed)50580-730Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50580-0730Add 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
50580-730-01	50580073001	1 BOTTLE, PLASTIC in 1 CARTON (50580-730-01) / 30 mL in 1 BOTTLE, PLASTICMarketed from Jan 16, 2017
50580-730-05	50580073005	1 BOTTLE, PLASTIC in 1 CARTON (50580-730-05) / 118 mL in 1 BOTTLE, PLASTICMarketed from Jul 13, 2015
50580-730-06	50580073006	2 CARTON in 1 PACKAGE (50580-730-06) / 1 BOTTLE, PLASTIC in 1 CARTON / 118 mL in 1 BOTTLE, PLASTICMarketed from Jul 31, 2015
50580-730-17	50580073017	3 TRAY in 1 PACKAGE (50580-730-17) / 1 BOTTLE in 1 TRAY / 118 mL in 1 BOTTLEMarketed from Dec 3, 2018
50580-730-18	50580073018	2 CARTON in 1 PACKAGE (50580-730-18) / 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLEMarketed from Dec 3, 2018
50580-730-19	50580073019	1 BOTTLE, PLASTIC in 1 CARTON (50580-730-19) / 240 mL in 1 BOTTLE, PLASTICMarketed from Jun 16, 2020

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 Zyrtec
Generic name (nonproprietary): cetirizine hydrochloride
Active ingredients: Cetirizine hydrochloride — 5 mg/5mL
Dosage form: Syrup
Route: Oral
Labeler: Kenvue Brands LLC
Product type: Over-the-counter drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022155
Marketing start: Jun 1, 2009
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 50580-730_40cb0507-49ef-8320-e063-6294a90ae39fSPL ID 40cb0507-49ef-8320-e063-6294a90ae39fSPL set ID 9d8e78ea-af98-4f7c-8db5-044b49582f80RxCUI 1014673, 1020021UNII 64O047KTOAUPC 0300450209269
Pharmacologic class: Histamine-1 Receptor Antagonist

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

N450580073001 followed by a unit qualifier and the quantity

Package 50580-0730-01. 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 NDA 022155

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

FDA NDC Directory listings under NDA 022155
Product	Strength	Form · route	Labeler	Product NDC
Zyrtec Hivescetirizine hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Kenvue Brands LLC	50580-128
Childrens Zyrtec Allergycetirizine hydrochloride	Cetirizine hydrochloride 5 mg/5mL	SyrupOral	Kenvue Brands LLC	50580-721