What is NDC 63981-475?

63981-475 is the product NDC for Kirkland Signature Childrens Aller Tec, Cetirizine hydrochloride 5 mg/5mL solution, listed with the FDA by Costco Wholesale Company. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Kirkland Signature Childrens Aller Tec (Cetirizine HCl).

Costco Wholesale Company, NDC labeler code 63981. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Kirkland Signature Childrens Aller Tec?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Kirkland Signature Childrens Aller Tec NDC 63981-475

NDC codes

FDA NDC Directory

Product NDC (as listed)63981-475Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63981-0475Add 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
63981-475-43	6398104754363981047543	2 BOTTLE in 1 CARTON (63981-475-43) / 240 mL in 1 BOTTLE (63981-475-34)Marketed from Jul 8, 2016

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): Kirkland Signature Childrens Aller Tec
Generic name (nonproprietary): cetirizine hcl
Active ingredients: Cetirizine hydrochloride — 5 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Costco Wholesale CompanyNDC labeler code 63981
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204226
Marketing start: Jul 8, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 63981-475_fcdbe753-6a33-4c46-acfe-3ead668364ecSPL ID fcdbe753-6a33-4c46-acfe-3ead668364ecSPL set ID eb14a311-7918-4c4b-ae05-7606cfb8a4afRxCUI 1014673, 1020017UNII 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

N463981047543 followed by a unit qualifier and the quantity

Package 63981-0475-43. 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 4, 2023.

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 63981-475

What is NDC 63981-475?: 63981-475 is the product NDC for Kirkland Signature Childrens Aller Tec, Cetirizine hydrochloride 5 mg/5mL solution, listed with the FDA by Costco Wholesale Company. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Kirkland Signature Childrens Aller Tec (Cetirizine HCl).
What is the active ingredient?: Cetirizine hydrochloride.
Who is the labeler?: Costco Wholesale Company, NDC labeler code 63981. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Kirkland Signature Childrens Aller Tec?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 204226

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

FDA NDC Directory listings under ANDA 204226
Product	Strength	Form · route	Labeler	Product NDC
Good Neighbor Pharmacy Childrens All Day Allergycetirizine hcl	Cetirizine hydrochloride 5 mg/5mL	SolutionOral	Amerisource Bergen	46122-203
childrens all day allergycetirizine hcl	Cetirizine hydrochloride 5 mg/5mL	SolutionOral	Kroger Company	30142-189
Good Sense Childrens All Day Allergycetirizine hcl	Cetirizine hydrochloride 5 mg/5mL	SolutionOral	A-S Medication Solutions	50090-7068
childrens allergy reliefcetirizine hydrochloride	Cetirizine hydrochloride 5 mg/5mL	SolutionOral	Walgreen Company	0363-3393
childrens allergy reliefcetirizine hcl	Cetirizine hydrochloride 5 mg/5mL	SolutionOral	Rite Aid Corporation	11822-0475
Members Mark Childrens Cetirizinecetirizine hydrochloride	Cetirizine hydrochloride 5 mg/5mL	SolutionOral	Sam's West Inc	68196-475
up and up childrens allergycetirizine hydrochloride	Cetirizine hydrochloride 5 mg/5mL	SolutionOral	Target Corporation	82442-475
Basic Care Childrens All Day Allergycetirizine hcl	Cetirizine hydrochloride 5 mg/5mL	SolutionOral	Amazon.com Services LLC	72288-330
Equaline childrens all day allergycetirizine hcl	Cetirizine hydrochloride 5 mg/5mL	SolutionOral	United Natural Foods, Inc. dba UNFI	41163-475
Topcare Childrens All Day Allergycetirizine hcl	Cetirizine hydrochloride 5 mg/5mL	SolutionOral	Topco Associates LLC	36800-189
Childrens All Day Allergycetirizine hcl	Cetirizine hydrochloride 5 mg/5mL	SolutionOral	Amazon.com Services LLC	72288-982
Good Sense Childrens All Day Allergycetirizine hcl	Cetirizine hydrochloride 5 mg/5mL	SolutionOral	L. Perrigo Company	0113-0189
foster and thrive childrens allergy reliefcetirizine hcl	Cetirizine hydrochloride 5 mg/5mL	SolutionOral	Strategic Sourcing Services LLC	70677-1042
Childrens 24 Hour Allergycetirizine hcl	Cetirizine hydrochloride 5 mg/5mL	SolutionOral	Meijer Distribution Inc	41250-475
Childrens Allergy Reliefcetirizine hcl	Cetirizine hydrochloride 5 mg/5mL	SolutionOral	CVS Pharmacy	59779-509
childrens cetirizine hydrochloridecetirizine hcl	Cetirizine hydrochloride 5 mg/5mL	SolutionOral	Preferred Pharmaceuticals Inc.	68788-8188
Childrens All Day Allergycetirizine hcl	Cetirizine hydrochloride 5 mg/5mL	SolutionOral	Kroger Company	30142-475
basic care childrens all day allergycetirizine hcl	Cetirizine hydrochloride 5 mg/5mL	SolutionOral	Amazon.com Services LLC	72288-475
Welby Childrens Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 5 mg/5mL	SolutionOral	Aldi Inc	64024-475
childrens allergy reliefcetirizine hcl	Cetirizine hydrochloride 5 mg/5mL	SolutionOral	Rite Aid Corporation	11822-1189

Showing 20 of 39.

Kirkland Signature Childrens Aller Tec (Cetirizine hcl) NDC 63981-475