FDA.reportPublic FDA data

Fexofenadine HCl

Product NDC
11822-7661
11-digit product format
118227661
Labeler code
11822
Product ID
11822-7661_46553fb2-9547-c6e0-e063-6394a90a2633
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Rite Aid
Application
ANDA211075
Marketing category
ANDA
Marketing start
2024-10-25
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
2027-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2019-10-18
A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2019-10-18

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine HClFEXOFENADINE HCLRite Aid1ddae2a1-0e16-e294-e063-6394a90a05f52025-12-19WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients

warnings

When using this product 􀂄 do not take more than directed 􀂄 do not take at the same time as aluminum or magnesium antacids 􀂄 do not take with fruit juices (see Directions)

Additional Listing Data#

Finished product
Yes
Brand name base
Fexofenadine HCl
Listing expiration
2027-12-31

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
11822-7661-5Fexofenadine HCl766 in 1 BOTTLETABLET7663

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-7661FEXOFENADINE HCL TABLET [RITE AID]2Current NDC, 1 package rows20241226_1ddae2a1-0e16-e294-e063-6394a90a05f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN1ddae2a1-0e16-e294-e063-6394a90a05f53
997420fexofenadine hydrochloride 180 MG Oral TabletSCD1ddae2a1-0e16-e294-e063-6394a90a05f53
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY1ddae2a1-0e16-e294-e063-6394a90a05f53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11822-7661-511822766105766 TABLET in 1 BOTTLE (11822-7661-5) 766 tablet2024-10-25NoNoCurrent