kirkland signature aller tec

Product NDC
63981-458
11-digit product format
639810458
Labeler code
63981
Product ID
63981-458_11b36474-0f5b-4454-8e5e-023c36ddad54
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Costco Wholesale Company
Application
ANDA078336
Marketing category
ANDA
Marketing start
2008-03-25
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
kirkland signature aller tec
Brand name suffix
allergy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014678, 1991946

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63981-458-00kirkland signature aller tecallergy1 in 1 BLISTER PACKTABLET, FILM COATED19
63981-458-00kirkland signature aller tecallergy5 in 1 CARTONTABLET, FILM COATED59
63981-458-88kirkland signature aller tecallergy1 in 1 PACKAGETABLET, FILM COATED19
63981-458-88kirkland signature aller tecallergy365 in 1 BOTTLETABLET, FILM COATED3659

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63981-458-88EA - Each63981-4589143d56c-2045-40a6-a9f8-048aba1576d912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOAKIRKLAND SIGNATURE ALLER TEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [COSTCO WHOLESALE COMPANY]4
CETIRIZINEACTIVE MOIETYYO7261ME24KIRKLAND SIGNATURE ALLER TEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [COSTCO WHOLESALE COMPANY]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOKIRKLAND SIGNATURE ALLER TEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [COSTCO WHOLESALE COMPANY]4
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GKIRKLAND SIGNATURE ALLER TEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [COSTCO WHOLESALE COMPANY]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30KIRKLAND SIGNATURE ALLER TEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [COSTCO WHOLESALE COMPANY]4
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEKIRKLAND SIGNATURE ALLER TEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [COSTCO WHOLESALE COMPANY]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AKIRKLAND SIGNATURE ALLER TEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [COSTCO WHOLESALE COMPANY]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EKIRKLAND SIGNATURE ALLER TEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [COSTCO WHOLESALE COMPANY]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJKIRKLAND SIGNATURE ALLER TEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [COSTCO WHOLESALE COMPANY]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPKIRKLAND SIGNATURE ALLER TEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [COSTCO WHOLESALE COMPANY]4
TRIACETININACTIVE INGREDIENTXHX3C3X673KIRKLAND SIGNATURE ALLER TEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [COSTCO WHOLESALE COMPANY]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63981-458KIRKLAND SIGNATURE ALLER TEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]8Current NDC, Legacy NDC, 4 package rows20230531_d4a688aa-02d4-4af6-9a91-ed31679cfaf8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1991946Aller-Tec 10 MG Oral TabletPSNd4a688aa-02d4-4af6-9a91-ed31679cfaf89
1014678cetirizine HCl 10 MG Oral TabletPSNd4a688aa-02d4-4af6-9a91-ed31679cfaf89
1991946cetirizine hydrochloride 10 MG Oral Tablet [Aller-Tec]SBDd4a688aa-02d4-4af6-9a91-ed31679cfaf89
1014678cetirizine hydrochloride 10 MG Oral TabletSCDd4a688aa-02d4-4af6-9a91-ed31679cfaf89
1991946Aller-Tec 10 MG Oral TabletSYd4a688aa-02d4-4af6-9a91-ed31679cfaf89
1014678cetirizine HCl 10 MG Oral TabletSYd4a688aa-02d4-4af6-9a91-ed31679cfaf89

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63981-458-00639810458005 BLISTER PACK in 1 CARTON (63981-458-00) > 1 TABLET, FILM COATED in 1 BLISTER PACK5 blister pack2019-03-010000-00-00NoNoCurrent
63981-458-88639810458881 BOTTLE in 1 PACKAGE (63981-458-88) / 365 TABLET, FILM COATED in 1 BOTTLE1 bottle2008-10-150000-00-00NoNoCurrent