What is NDC 63981-612?

63981-612 is the product NDC for kirkland signature allerclear (loratadine), Loratadine 10 mg/1 tablet, 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 allerclear (Loratadine).

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 allerclear?

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 allerclear NDC 63981-612

NDC codes

FDA NDC Directory

Product NDC (as listed)63981-612Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63981-0612Add 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
63981-612-88	6398106128863981061288	1 BOTTLE in 1 PACKAGE (63981-612-88) / 365 TABLET in 1 BOTTLEMarketed from Oct 15, 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): kirkland signature allerclear
Generic name (nonproprietary): loratadine
Active ingredients: Loratadine — 10 mg/1
Dosage form: Tablet
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 076301
Marketing start: Oct 15, 2010
Listing expires: Dec 31, 2027
Identifiers: Product ID 63981-612_39dbaef4-0637-4ba0-9af1-ccb87eb17dafSPL ID 39dbaef4-0637-4ba0-9af1-ccb87eb17dafSPL set ID 2074d52e-8c0a-4e69-bfb1-864ffc07e25fRxCUI 311372UNII 7AJO3BO7QN

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

N463981061288 followed by a unit qualifier and the quantity

Package 63981-0612-88. 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 Jan 17, 2024.

Indications (excerpt from the label)

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • itchy, watery eyes • sneezing • 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 63981-612

What is NDC 63981-612?: 63981-612 is the product NDC for kirkland signature allerclear (loratadine), Loratadine 10 mg/1 tablet, 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 allerclear (Loratadine).
What is the active ingredient?: Loratadine.
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 allerclear?: 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 076301

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

FDA NDC Directory listings under ANDA 076301
Product	Strength	Form · route	Labeler	Product NDC
equate allergy reliefloratadine	Loratadine 10 mg/1	TabletOral	Wal-Mart Stores Inc	49035-612
Loratadine antihistamineloratadine	Loratadine 10 mg/1	TabletOral	Proficient Rx LP	63187-601
Loratadine	Loratadine 10 mg/1	TabletOral	A-S Medication Solutions	50090-7066
TopCare Allergy Relief 24 hourloratadine	Loratadine 10 mg/1	TabletOral	Topco Associates LLC	36800-612
Loratadine antihistamineloratadine	Loratadine 10 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	66267-653
Berkley and Jensen Allergy Reliefloratadine	Loratadine 10 mg/1	TabletOral	BJWC	68391-314
good sense allergy reliefloratadine	Loratadine 10 mg/1	TabletOral	L. Perrigo Company	0113-1612
Loratadine antihistamineloratadine	Loratadine 10 mg/1	TabletOral	A-S Medication Solutions	50090-0836
allergy reliefloratadine	Loratadine 10 mg/1	TabletOral	Rite Aid Corporation	11822-0612
members mark allergy reliefloratadine	Loratadine 10 mg/1	TabletOral	Sam's West Inc	68196-711
good sense allergy reliefloratadine	Loratadine 10 mg/1	TabletOral	L. Perrigo Company	0113-0612
Loratadine	Loratadine 10 mg/1	TabletOral	A-S Medication Solutions	50090-5532
Loratadine	Loratadine 10 mg/1	TabletOral	A-S Medication Solutions	50090-7158
Loratadine	Loratadine 10 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-423
foster and thrive allergy reliefloratadine	Loratadine 10 mg/1	TabletOral	Strategic Sourcing Services LLC	70677-1022
Loratadine	Loratadine 10 mg/1	TabletOral	Major Pharmaceuticals	0904-6852
exchange select allergy reliefloratadine	Loratadine 10 mg/1	TabletOral	Army & Air Force Exchange Service	55301-612
allergy reliefloratadine	Loratadine 10 mg/1	TabletOral	Walgreen Company	0363-1612
allergy reliefloratadine	Loratadine 10 mg/1	TabletOral	CVS Pharmacy	59779-612
allergy reliefloratadine	Loratadine 10 mg/1	TabletOral	Meijer Distribution Inc	41250-612

Showing 20 of 39.

kirkland signature allerclear (Loratadine) NDC 63981-612