FDA.reportPublic FDA data

Fexofenadine hydrochloride

Product NDC
53943-021
11-digit product format
539430021
Labeler code
53943
Product ID
53943-021_1d982c6e-4506-410b-82d8-602993fd5805
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Discount Drug Mart
Application
ANDA202039
Marketing category
ANDA
Marketing start
2015-05-06
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53943-021IInactivated by FDA2026-07-31
excluded packagepackage53943-02153943-021-09IInactivated by FDA2026-07-31
excluded packagepackage53943-02153943-021-17IInactivated by FDA2026-07-31
excluded packagepackage53943-02153943-021-85IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2014-11-19
A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2014-11-19
A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2014-11-19

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-19a50c72e98297…
2026-08-01 22:54:322026-06A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2014-11-19a50c72e98297…
2026-08-01 22:54:322026-06A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2014-11-19a50c72e98297…

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. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDE7-elevend5914c05-e8db-4c79-82d0-a279d13041182019-06-20WarningsExact identifier
application applno (ANDA): 202039
application number: ANDA202039

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53943-021-092023-01-30C16284748780-1f386c649-d361-0266-e053-dadaa90a7c1aab09fd7c-b1a7-4bf9-9f86-801331a6588e
53943-021-172023-01-30C16284748780-1f386c649-d361-0266-e053-dadaa90a7c1aab09fd7c-b1a7-4bf9-9f86-801331a6588e
53943-021-852023-01-30C16284748780-1f386c649-d361-0266-e053-dadaa90a7c1aab09fd7c-b1a7-4bf9-9f86-801331a6588e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-021-09Fexofenadine hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
53943-021-09Fexofenadine hydrochloride1 in 1 CARTONTABLET, FILM COATED12
53943-021-17Fexofenadine hydrochloride1 in 1 CARTONTABLET, FILM COATED12
53943-021-17Fexofenadine hydrochloride45 in 1 BOTTLETABLET, FILM COATED452
53943-021-60Fexofenadine hydrochloride5 in 1 BLISTER PACKTABLET, FILM COATED52
53943-021-85Fexofenadine hydrochloride3 in 1 CARTONTABLET, FILM COATED32

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [DISCOUNT DRUG MART]1
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [DISCOUNT DRUG MART]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [DISCOUNT DRUG MART]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [DISCOUNT DRUG MART]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [DISCOUNT DRUG MART]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [DISCOUNT DRUG MART]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [DISCOUNT DRUG MART]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [DISCOUNT DRUG MART]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [DISCOUNT DRUG MART]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [DISCOUNT DRUG MART]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [DISCOUNT DRUG MART]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [DISCOUNT DRUG MART]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [DISCOUNT DRUG MART]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-021FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [DISCOUNT DRUG MART]2Legacy NDC, 6 package rows20190911_ab09fd7c-b1a7-4bf9-9f86-801331a6588e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNab09fd7c-b1a7-4bf9-9f86-801331a6588e2
997420fexofenadine hydrochloride 180 MG Oral TabletSCDab09fd7c-b1a7-4bf9-9f86-801331a6588e2
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYab09fd7c-b1a7-4bf9-9f86-801331a6588e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53943-021-09539430021091 BOTTLE in 1 CARTON (53943-021-09) > 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-05-060000-00-00NoNoCurrent
53943-021-17539430021171 BOTTLE in 1 CARTON (53943-021-17) > 45 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-05-060000-00-00NoNoCurrent
53943-021-60539430021605 in 1 BLISTER PACKHistorical
53943-021-85539430021853 BLISTER PACK in 1 CARTON (53943-021-85) > 5 TABLET, FILM COATED in 1 BLISTER PACK (53943-021-60) 3 blister pack2015-05-060000-00-00NoNoCurrent