FDA.reportPublic FDA data

FEXOFENADINE HYDROCHLORIDE

Product NDC
46122-779
11-digit product format
461220779
Labeler code
46122
Product ID
46122-779_76ea7e25-e968-4c78-9eca-ac960ad55985
Type
HUMAN OTC DRUG
Nonproprietary name
FEXOFENADINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AMERISOURCE BERGEN
Application
ANDA091567
Marketing category
ANDA
Marketing start
2024-05-14
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
FEXOFENADINE HYDROCHLORIDE
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
46122-779-58FEXOFENADINE HYDROCHLORIDE5 in 1 BLISTER PACKTABLET, FILM COATED51
46122-779-58FEXOFENADINE HYDROCHLORIDE3 in 1 CARTONTABLET, FILM COATED31
46122-779-61FEXOFENADINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED301
46122-779-61FEXOFENADINE HYDROCHLORIDE1 in 1 CARTONTABLET, FILM COATED11
46122-779-66FEXOFENADINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED901
46122-779-66FEXOFENADINE HYDROCHLORIDE1 in 1 CARTONTABLET, FILM COATED11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-779-58EA - Each46122-779929ecaf9-eec9-46e8-8ef7-3c83c1f2f82012025-02-10
46122-779-61EA - Each46122-7792d01b6b2-2bb0-4c43-9390-451a48560a3d12025-02-10
46122-779-66EA - Each46122-779e4775287-7bc1-43df-8ccd-ce865728dd7c12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-779FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AMERISOURCE BERGEN]1Current NDC, 6 package rows20240518_2a578643-adc1-44ca-83f2-9d48527bd3a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN2a578643-adc1-44ca-83f2-9d48527bd3a41
997420fexofenadine hydrochloride 180 MG Oral TabletSCD2a578643-adc1-44ca-83f2-9d48527bd3a41
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY2a578643-adc1-44ca-83f2-9d48527bd3a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46122-779-58461220779583 BLISTER PACK in 1 CARTON (46122-779-58) / 5 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2024-05-14NoNoCurrent
46122-779-61461220779611 BOTTLE in 1 CARTON (46122-779-61) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-05-14NoNoCurrent
46122-779-66461220779661 BOTTLE in 1 CARTON (46122-779-66) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-05-14NoNoCurrent