NDC codes

FDA NDC Directory
Product NDC (as listed)63981-458Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63981-0458Add 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 NDC11-digit (billing)PackageCopy
63981-458-8863981045888639810458881 BOTTLE in 1 PACKAGE (63981-458-88) / 365 TABLET, FILM COATED in 1 BOTTLEMarketed from Oct 15, 2008

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 aller tec allergySuffix: allergy
Generic name (nonproprietary)
cetirizine hydrochloride
Active ingredients
Cetirizine hydrochloride — 10 mg/1
Dosage form
Tablet, Film coated
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 078336
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 63981-458_11b36474-0f5b-4454-8e5e-023c36ddad54SPL ID 11b36474-0f5b-4454-8e5e-023c36ddad54SPL set ID d4a688aa-02d4-4af6-9a91-ed31679cfaf8RxCUI 1014678, 1991946UNII 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

N463981045888 followed by a unit qualifier and the quantity

Package 63981-0458-88. 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 .

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 63981-458

What is NDC 63981-458?
63981-458 is the product NDC for kirkland signature aller tec allergy, Cetirizine hydrochloride 10 mg/1 tablet, film coated, 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 aller tec allergy (Cetirizine Hydrochloride).
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 aller tec allergy?
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 078336

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

FDA NDC Directory listings under ANDA 078336
ProductStrengthForm · routeLabelerProduct NDC
Cetirizinecetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6717
signature care allergy reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralSafeway21130-090
Good Sense all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7064
Exchange select all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralArmy & Air Force Exchange Service55301-076
Good Sense all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7065
Members Mark Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralSam's West Inc68196-413
Berkley And Jensen All Day Allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralBJWC68391-400
Cetirizinecetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralVERITYRX, LLC83939-0003
Equaline all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralUnited Natural Foods, Inc. dba UNFI41163-458
Cetirizinecetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5510
dg health all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralDolgencorp Inc55910-458
allergy reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralWalgreen Company0363-4101
basic care all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-411
Allergy Relief Indoor and Outdoor Allergiescetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralCVS Pharmacy59779-458
Cetirizinecetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2162
24 hour allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralMeijer Distribution Inc41250-458
Medline Industriescetirizine hclCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralMedline Industries, LP53329-036
all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralRite Aid Corporation11822-1002
cetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2173
Good Sense all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc68788-4023

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