What is NDC 80513-731?

80513-731 is the product NDC for Cetirizine hydrochloride, Cetirizine hydrochloride 10 mg/1 tablet, coated, listed with the FDA by Advanced Rx LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Advanced Rx LLC, NDC labeler code 80513. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Cetirizine hydrochloride?

104 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cetirizine hydrochloride NDC 80513-731

NDC codes

FDA NDC Directory

Product NDC (as listed)80513-731Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80513-0731Add 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
80513-731-05	8051307310580513073105	500 TABLET, COATED in 1 BOTTLE (80513-731-05)Marketed from May 1, 2025
80513-731-12	8051307311280513073112	120 TABLET, COATED in 1 BOTTLE (80513-731-12)Marketed from May 1, 2025

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 hydrochloride
Active ingredients: Cetirizine hydrochloride — 10 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Advanced Rx LLCNDC labeler code 80513
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209274
Marketing start: May 1, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 80513-731_35019a5a-fbea-124b-e063-6394a90a5ec4SPL ID 35019a5a-fbea-124b-e063-6394a90a5ec4SPL set ID 737492bf-96bd-4f7c-aa42-4910746f44bbRxCUI 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

N480513073105 followed by a unit qualifier and the quantity

Package 80513-0731-05. 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 May 13, 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)

About NDC 80513-731

What is NDC 80513-731?: 80513-731 is the product NDC for Cetirizine hydrochloride, Cetirizine hydrochloride 10 mg/1 tablet, coated, listed with the FDA by Advanced Rx LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Cetirizine hydrochloride.
What is the active ingredient?: Cetirizine hydrochloride.
Who is the labeler?: Advanced Rx LLC, NDC labeler code 80513. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cetirizine hydrochloride?: 104 other product NDCs are listed under this name. See all Cetirizine hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Cetirizine hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Cetirizine Hydrochloride	Cetirizine hydrochloride 5 mg/1	TabletOral	First Nation Group, LLC	81469-352	81469-0352-01
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	First Nation Group, LLC	81469-353	81469-0353-0181469-0353-0381469-0353-05+1 more
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Safecor Health, LLC	48433-017	48433-0017-20
Cetirizine hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Advagen Pharma Ltd.,	72888-480	72888-0480-01
cetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4072	68788-4072-0368788-4072-0668788-4072-09
Cetirizine Hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Bionpharma Inc.	69452-426	69452-0426-5569452-0426-88
Cetirizine Hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Rising Pharma Holdings, Inc.	57237-357	57237-0357-1257237-0357-24
Cetirizine Hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Rising Pharma Holdings, Inc.	57237-358	57237-0358-1257237-0358-24
Cetirizine Hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	BAJAJ MEDICAL, LLC	61037-480	61037-0480-2261037-0480-2361037-0480-24+2 more
cetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-458	72789-0458-1072789-0458-3072789-0458-51+1 more

All 105 Cetirizine hydrochloride NDCs

Other NDCs under ANDA 209274

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

FDA NDC Directory listings under ANDA 209274
Product	Strength	Form · route	Labeler	Product NDC
Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, CoatedOral	FSA STORE INC.	81522-194
Allergy Reliefcetirizine hcl	Cetirizine hydrochloride 10 mg/1	TabletOral	WinCo Foods, LLC	67091-351
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	Granules USA, Inc.	69848-006
Pentrexcilina Day timecetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	OPMX LLC	69729-137
Cetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	OPMX LLC	69729-139
Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, CoatedOral	MARC GLASSMAN, INC.	68998-194
Wal-Zyrcetirizine hcl	Cetirizine hydrochloride 10 mg/1	TabletOral	Walgreens	0363-0606
Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, CoatedOral	Amerifoods Trading Company	61504-194
CAREALL Allergy Reliefcetirizine hcl	Cetirizine hydrochloride 10 mg/1	TabletOral	New World Imports	51824-104
Cetirizine Hydrochloride 10 Mgcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	SDA Laboratories, Inc.	66424-564
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	TWIN MED, LLC	55681-073
Cetirizine Hydrochloride 10 Mgcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	TWIN MED, LLC	55681-302
Curist Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, CoatedOral	Little Pharma, Inc.	72559-003
Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, CoatedOral	HARRIS TEETER	72036-194
Allergy Reliefcetirizine hcl	Cetirizine hydrochloride 10 mg/1	TabletOral	Camber Consumer Care	69230-304
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	RETAIL BUSINESS SERVICES,LLC.	72476-764
Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	Magno-Humphries, Inc.	54257-270
All Day Allergy Reliefcetirizine hcl	Cetirizine hydrochloride 10 mg/1	TabletOral	P & L Development, LLC	59726-806
Cetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, CoatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8479
Cetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, CoatedOral	A-S Medication Solutions	50090-6679

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