Cetirizine Hydrochloride NDC 0781-5283

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-5283Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-5283Add 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
0781-5283-64	00781528364	30 BLISTER PACK in 1 CARTON (0781-5283-64) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (0781-5283-06)Marketed from Feb 14, 2008

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Cetirizine Hydrochloride
Generic name (nonproprietary): cetirizine hydrochloride
Active ingredients: Cetirizine hydrochloride — 5 mg/1
Dosage form: Tablet, Chewable
Route: Oral
Labeler: Sandoz Inc
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078692
Marketing start: Feb 14, 2008
Listing expires: Dec 31, 2027
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 0781-5283_73150a55-d6f0-4ae0-847a-f9679694bf80SPL ID 73150a55-d6f0-4ae0-847a-f9679694bf80SPL set ID 817d07cf-5e31-421f-9e95-943bae01f5b0RxCUI 1014643UNII 64O047KTOA
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

N400781528364 followed by a unit qualifier and the quantity

Package 00781-5283-64. 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 Jun 30, 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 ANDA 078692

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

FDA NDC Directory listings under ANDA 078692
Product	Strength	Form · route	Labeler	Product NDC
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, ChewableOral	Sandoz Inc	0781-5284