FDA.reportPublic FDA data

Fexofenadine HCL

Product NDC
79903-358
11-digit product format
799030358
Labeler code
79903
Product ID
79903-358_35331f65-1bca-e95b-e063-6294a90a74e0
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCL
Dosage form
TABLET
Route
ORAL
Labeler
Walmart Inc.
Application
ANDA204097
Marketing category
ANDA
Marketing start
2025-05-19
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

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2016-08-19
A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2016-08-19
A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2016-08-19

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 HCLWalmart Inc.353323b7-67ce-7ce6-e063-6394a90a77d42026-07-21WarningsExact identifier

Warnings cross-check#

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

warnings

WARNINGS

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
79903-358-30Fexofenadine HCL300 in 1 BOTTLETABLET3001
79903-358-45Fexofenadine HCL1 in 1 CARTONTABLET11
79903-358-45Fexofenadine HCL45 in 1 BOTTLETABLET451
79903-358-90Fexofenadine HCL90 in 1 BOTTLETABLET901
79903-358-90Fexofenadine HCL2 in 1 CARTONTABLET21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79903-358FEXOFENADINE HCL TABLET [WALMART INC.]1Current NDC, 5 package rows20250524_353323b7-67ce-7ce6-e063-6394a90a77d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN353323b7-67ce-7ce6-e063-6394a90a77d41
997420fexofenadine hydrochloride 180 MG Oral TabletSCD353323b7-67ce-7ce6-e063-6394a90a77d41
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY353323b7-67ce-7ce6-e063-6394a90a77d41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79903-358-3079903035830300 TABLET in 1 BOTTLE (79903-358-30) 300 tablet2025-05-19NoNoCurrent
79903-358-45799030358451 BOTTLE in 1 CARTON (79903-358-45) / 45 TABLET in 1 BOTTLE1 bottle2025-05-19NoNoCurrent
79903-358-90799030358902 BOTTLE in 1 CARTON (79903-358-90) / 90 TABLET in 1 BOTTLE2 bottle2025-05-19NoNoCurrent