FDA.reportPublic FDA data

Allergy Relief

Product NDC
46122-462
11-digit product format
461220462
Labeler code
46122
Product ID
46122-462_e953eab7-ca21-0d52-9ddc-25b3c0720afb
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
AMERISOURCEBERGEN DRUG CORPORATION
Application
ANDA076502
Marketing category
ANDA
Marketing start
2018-02-20
Marketing end
2026-07-31
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy Relief

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
46122-462-22Allergy Relief3 in 1 CARTONTABLET35
46122-462-22Allergy Relief5 in 1 BLISTER PACKTABLET55
46122-462-61Allergy Relief45 in 1 BOTTLETABLET455
46122-462-61Allergy Relief1 in 1 CARTONTABLET15
46122-462-65Allergy Relief30 in 1 BOTTLETABLET305
46122-462-65Allergy Relief1 in 1 CARTONTABLET15
46122-462-75Allergy Relief1 in 1 CARTONTABLET15
46122-462-75Allergy Relief90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-462-22EA - Each46122-462841baaae-91fe-45d1-8dfb-e077aca263b612020-04-20
46122-462-61EA - Each46122-4625d805f13-67a6-4f7a-97f5-13cd9188485612020-04-20
46122-462-65EA - Each46122-46243cafefd-f84e-4b54-8845-4244f20ebeee12020-01-03
46122-462-75EA - Each46122-4625a05e174-8d1d-42e5-b8c3-0853940c0ff512020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-462ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [AMERISOURCEBERGEN DRUG CORPORATION]4Current NDC, Legacy NDC, 8 package rows20230628_cafb5240-6bc1-1bf5-f12f-00d9502d75fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNcafb5240-6bc1-1bf5-f12f-00d9502d75fe5
997420fexofenadine hydrochloride 180 MG Oral TabletSCDcafb5240-6bc1-1bf5-f12f-00d9502d75fe5
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYcafb5240-6bc1-1bf5-f12f-00d9502d75fe5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-462-22461220462223 BLISTER PACK in 1 CARTON (46122-462-22) > 5 TABLET in 1 BLISTER PACK3 blister pack2018-02-200000-00-00NoNoCurrent
46122-462-61461220462611 BOTTLE in 1 CARTON (46122-462-61) > 45 TABLET in 1 BOTTLE1 bottle2018-02-200000-00-00NoNoCurrent
46122-462-65461220462651 BOTTLE in 1 CARTON (46122-462-65) > 30 TABLET in 1 BOTTLE1 bottle2018-02-200000-00-00NoNoCurrent
46122-462-75461220462751 BOTTLE in 1 CARTON (46122-462-75) / 90 TABLET in 1 BOTTLE1 bottle2018-02-202026-07-31NoNoCurrent