kirkland signature aller fex

Product NDC
63981-847
11-digit product format
639810847
Labeler code
63981
Product ID
63981-847_9d7724ba-f3b3-4ac8-9558-42753f6fe838
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Costco Wholesale Company
Application
ANDA212971
Marketing category
ANDA
Marketing start
2021-08-19
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 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 fex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU
Rxcui997420

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63981-847-48kirkland signature aller fex180 in 1 BOTTLETABLET, FILM COATED1803
63981-847-48kirkland signature aller fex1 in 1 PACKAGETABLET, FILM COATED13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63981-847-48EA - Each63981-8476e9a5892-ada5-4d1a-aa34-c440831ad02b12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63981-847KIRKLAND SIGNATURE ALLER FEX (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]3Current NDC, Legacy NDC, 2 package rows20230515_651d14d1-c5de-4cb9-9484-b05986e641ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN651d14d1-c5de-4cb9-9484-b05986e641ac3
997420fexofenadine hydrochloride 180 MG Oral TabletSCD651d14d1-c5de-4cb9-9484-b05986e641ac3
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY651d14d1-c5de-4cb9-9484-b05986e641ac3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63981-847-48639810847481 BOTTLE in 1 PACKAGE (63981-847-48) / 180 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-08-190000-00-00NoNoCurrent