FDA.reportPublic FDA data

Fexofenadine hydrochloride

Product NDC
60000-409
11-digit product format
600000409
Labeler code
60000
Product ID
60000-409_df192c93-2573-457f-9583-f94557ed028e
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ahold U.S.A., Inc
Application
ANDA202039
Marketing category
ANDA
Marketing start
2015-01-15
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60000-409IInactivated by FDA2026-07-31
excluded packagepackage60000-40960000-409-30IInactivated by FDA2026-07-31
excluded packagepackage60000-40960000-409-45IInactivated by FDA2026-07-31
excluded packagepackage60000-40960000-409-48IInactivated by FDA2026-07-31
excluded packagepackage60000-40960000-409-53IInactivated 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
60000-409-302023-01-30C16284748780-1f386c64a-0a94-0266-e053-dadaa90a7c1ace7e5fc4-630a-4184-a7a8-9d877bfbadc4
60000-409-452023-01-30C16284748780-1f386c64a-0a94-0266-e053-dadaa90a7c1ace7e5fc4-630a-4184-a7a8-9d877bfbadc4
60000-409-482023-01-30C16284748780-1f386c64a-0a94-0266-e053-dadaa90a7c1ace7e5fc4-630a-4184-a7a8-9d877bfbadc4
60000-409-532023-01-30C16284748780-1f386c64a-0a94-0266-e053-dadaa90a7c1ace7e5fc4-630a-4184-a7a8-9d877bfbadc4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60000-409-30Fexofenadine hydrochloride1 in 1 CARTONTABLET, FILM COATED12
60000-409-30Fexofenadine hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
60000-409-45Fexofenadine hydrochloride1 in 1 CARTONTABLET, FILM COATED12
60000-409-45Fexofenadine hydrochloride45 in 1 BOTTLETABLET, FILM COATED452
60000-409-48Fexofenadine hydrochloride1 in 1 CARTONTABLET, FILM COATED12
60000-409-48Fexofenadine hydrochloride45 in 1 BOTTLETABLET, FILM COATED452
60000-409-53Fexofenadine hydrochloride1 in 1 CARTONTABLET, FILM COATED12
60000-409-53Fexofenadine hydrochloride15 in 1 BLISTER PACKTABLET, FILM COATED152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60000-409FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AHOLD U.S.A., INC]2Legacy NDC, 8 package rows20190911_ce7e5fc4-630a-4184-a7a8-9d877bfbadc4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNce7e5fc4-630a-4184-a7a8-9d877bfbadc42
997420fexofenadine hydrochloride 180 MG Oral TabletSCDce7e5fc4-630a-4184-a7a8-9d877bfbadc42
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYce7e5fc4-630a-4184-a7a8-9d877bfbadc42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60000-409-30600000409301 BOTTLE in 1 CARTON (60000-409-30) > 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-01-150000-00-00NoNoCurrent
60000-409-45600000409451 BOTTLE in 1 CARTON (60000-409-45) > 45 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-01-150000-00-00NoNoCurrent
60000-409-48600000409481 BOTTLE in 1 CARTON (60000-409-48) > 45 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-01-150000-00-00NoNoCurrent
60000-409-53600000409531 BLISTER PACK in 1 CARTON (60000-409-53) > 15 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2015-01-150000-00-00NoNoCurrent