Cetirizine Hydrochloride NDC 0781-1684

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-1684Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-1684Add 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
0781-1684-01	00781168401	100 TABLET in 1 BOTTLE (0781-1684-01)Marketed from Dec 27, 2007
0781-1684-64	00781168464	30 TABLET in 1 BOX, UNIT-DOSE (0781-1684-64)Marketed from Dec 27, 2007

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 — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Sandoz Inc
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077946
Marketing start: Dec 27, 2007
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 0781-1684_2ca4b053-0031-4a34-a1b1-8eaadb0879c6SPL ID 2ca4b053-0031-4a34-a1b1-8eaadb0879c6SPL set ID 760dd0e4-280a-4d95-8938-cecaa7ec75f2RxCUI 1014678UNII 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

N400781168401 followed by a unit qualifier and the quantity

Package 00781-1684-01. 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

Current FDA label (SPL), effective Jun 3, 2013.

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 077946

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

FDA NDC Directory listings under ANDA 077946
Product	Strength	Form · route	Labeler	Product NDC
All Day Allergy Reliefcetirizine hcl	Cetirizine hydrochloride 10 mg/1	TabletOral	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	55910-039