Cetirizine Hydrochloride (cetirizine) NDC 65162-045

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-045Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0045Add 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
65162-045-03	65162004503	1 BOTTLE in 1 CARTON (65162-045-03) / 30 TABLET in 1 BOTTLEMarketed from Jan 21, 2010
65162-045-50	65162004550	500 TABLET in 1 BOTTLE (65162-045-50)Marketed from Jan 21, 2010

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): Cetirizine Hydrochloride
Generic name (nonproprietary): cetirizine
Active ingredients: Cetirizine hydrochloride — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals LLC
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078780
Marketing start: Jan 21, 2010
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 65162-045_79a66101-ea46-4515-bb20-ce790b750d70SPL ID 79a66101-ea46-4515-bb20-ce790b750d70SPL set ID 214936a2-adc4-422a-a8fe-4c3ce9e01f36RxCUI 1014676UNII 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

N465162004503 followed by a unit qualifier and the quantity

Package 65162-0045-03. 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 Jul 31, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE 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 078780

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

FDA NDC Directory listings under ANDA 078780
Product	Strength	Form · route	Labeler	Product NDC
Cetirizine Hydrochloridecetirizine	Cetirizine hydrochloride 10 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-046
Allergy Relief All Daycetirizine hcl	Cetirizine hydrochloride 10 mg/1	TabletOral	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	55910-129
Cetirizine Hydrochloride Hives Reliefcetirizine	Cetirizine hydrochloride 5 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-145