Zyrtec Allergy (cetirizine hydrochloride) NDC 50580-778

NDC codes

FDA NDC Directory

Product NDC (as listed)50580-778Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50580-0778Add 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
50580-778-24	50580077824	4 BLISTER PACK in 1 CARTON (50580-778-24) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Jan 20, 2014

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): Zyrtec Allergy
Generic name (nonproprietary): cetirizine hydrochloride
Active ingredients: Cetirizine hydrochloride — 10 mg/1
Dosage form: Tablet, Orally disintegrating
Route: Oral
Labeler: Kenvue Brands LLC
Product type: Over-the-counter drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022578
Marketing start: Jan 20, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 50580-778_3254957b-3bb2-98a9-e063-6394a90a9358SPL ID 3254957b-3bb2-98a9-e063-6394a90a9358SPL set ID 6a962a1c-c197-492b-bfa6-e0c28eda1533RxCUI 1011482, 1011485UNII 64O047KTOAUPC 0300450242242
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

N450580077824 followed by a unit qualifier and the quantity

Package 50580-0778-24. 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 Apr 11, 2025.

Indications (excerpt from the label)

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022578

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

FDA NDC Directory listings under NDA 022578
Product	Strength	Form · route	Labeler	Product NDC
Childrens Zyrtec Allergycetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Orally disintegratingOral	Kenvue Brands LLC	50580-782