What is NDC 0615-8479?

0615-8479 is the product NDC for Cetirizine hydrochloride, Cetirizine hydrochloride 10 mg/1 tablet, coated, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, shown above in 10- and 11-digit form.

NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 0615-8479

NDC codes

FDA NDC Directory

Product NDC (as listed)0615-8479Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00615-8479Add 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
0615-8479-39	00615847939	30 TABLET, COATED in 1 BLISTER PACK (0615-8479-39)Marketed from Jul 31, 2023

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, Coated
Route: Oral
Labeler: NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209274
Marketing start: Jan 13, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 0615-8479_1125df7c-ba82-46fe-a411-05322146a3b9SPL ID 1125df7c-ba82-46fe-a411-05322146a3b9SPL set ID b53d5e8a-a30c-4025-aa72-d2776a112e3eRxCUI 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

N400615847939 followed by a unit qualifier and the quantity

Package 00615-8479-39. 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 24, 2024.

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 0615-8479

What is NDC 0615-8479?: 0615-8479 is the product NDC for Cetirizine hydrochloride, Cetirizine hydrochloride 10 mg/1 tablet, coated, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, 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?: NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 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	TabletOral	Bi-Mar	37835-611	37835-0611-1437835-0611-3537835-0611-90
Cetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, CoatedOral	Advanced Rx LLC	80513-731	80513-0731-0580513-0731-12

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
All Day Allergy Reliefcetirizine hcl	Cetirizine hydrochloride 10 mg/1	TabletOral	P & L Development, LLC	59726-806
All Day Allergy Reliefcetirizine hcl	Cetirizine hydrochloride 10 mg/1	TabletOral	Strategic Sourcing Services LLC	70677-0057
Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, CoatedOral	United Natural Foods, Inc. dba UNFI	41163-197
Allergy Reliefcetirizine hcl	Cetirizine hydrochloride 10 mg/1	TabletOral	CVS PHARMACY, INC	51316-806
Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, CoatedOral	DISCOUNT DRUG MART	53943-194
Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	Magno-Humphries, Inc.	54257-270
Allergy Reliefcetirizine hcl	Cetirizine hydrochloride 10 mg/1	TabletOral	Family Dollar (FAMILY WELLNESS)	55319-962
Allergy Reliefcetirizine hcl	Cetirizine hydrochloride 10 mg/1	TabletOral	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	55910-930
Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, CoatedOral	AAA PHARMACEUTICAL, INC.	57344-194
Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, CoatedOral	Amerifoods Trading Company	61504-194
Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, CoatedOral	CHAIN DRUG MARKETING ASSOCIATION INC.	63868-665
Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, CoatedOral	VALU MERCHANDISERS COMPANY	63941-194
Allergy Reliefcetirizine hcl	Cetirizine hydrochloride 10 mg/1	TabletOral	WinCo Foods, LLC	67091-351
Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, CoatedOral	WINCO FOODS, LLC	67091-494
Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Spirit Pharmaceutical LLC	68210-4219
Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Spirit Pharmaceutical LLC	68210-4230
Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, CoatedOral	MARC GLASSMAN, INC.	68998-194
Allergy Reliefcetirizine hcl 10 mg	Cetirizine hydrochloride 10 mg/1	TabletOral	Allegiant Health	69168-396
Allergy Reliefcetirizine hcl	Cetirizine hydrochloride 10 mg/1	TabletOral	Camber Consumer Care	69230-304
Allergy Reliefcetirizine hcl	Cetirizine hydrochloride 10 mg/1	TabletOral	Strategic Sourcing Services LLC	70677-1047

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