FDA.reportPublic FDA data

Fexofenadine Hydrochloride

Product NDC
43353-760
11-digit product format
433530760
Labeler code
43353
Product ID
43353-760_3b6da186-33ef-4a85-90df-f008a31ab498
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077081
Marketing category
ANDA
Marketing start
2014-03-20
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43353-760IInactivated by FDA2026-07-31
excluded packagepackage43353-76043353-760-53IInactivated by FDA2026-07-31
excluded packagepackage43353-76043353-760-60IInactivated 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 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077081-001FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2007-04-16
A077081-002FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2008-04-11
A077081-003FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2008-04-11
A077081-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2011-07-21
A077081-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2011-07-21
A077081-006FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2011-07-21
A077081-007FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2011-07-21
A077081-008FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2011-07-21
A077081-009FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2011-07-21

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 22:54:322026-06A077081-001FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2007-04-16a50c72e98297…
2026-08-01 22:54:322026-06A077081-002FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2008-04-11a50c72e98297…
2026-08-01 22:54:322026-06A077081-003FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2008-04-11a50c72e98297…
2026-08-01 22:54:322026-06A077081-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-07-21a50c72e98297…
2026-08-01 22:54:322026-06A077081-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-07-21a50c72e98297…
2026-08-01 22:54:322026-06A077081-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-07-21a50c72e98297…
2026-08-01 22:54:322026-06A077081-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-07-21a50c72e98297…
2026-08-01 22:54:322026-06A077081-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-07-21a50c72e98297…
2026-08-01 22:54:322026-06A077081-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-07-21a50c72e98297…

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
43353-760-532020-01-31C16284748780-19d75b9d0-9b1d-f424-e053-dadaa90a57ceDrug Facts
43353-760-602020-01-31C16284748780-19d75b9d0-9b1d-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-760-53Fexofenadine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
43353-760-60Fexofenadine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-760-60EA - Each43353-760a494b8e8-82f5-46f1-ad3f-2566270ee2e112018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-760FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 2 package rows20171205_d0a79081-71e0-407d-876b-f4393fd4d1e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNd0a79081-71e0-407d-876b-f4393fd4d1e51
997420fexofenadine hydrochloride 180 MG Oral TabletSCDd0a79081-71e0-407d-876b-f4393fd4d1e51
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYd0a79081-71e0-407d-876b-f4393fd4d1e51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-760-534335307605330 in 1 BOTTLE, PLASTICHistorical
43353-760-604335307606090 in 1 BOTTLE, PLASTICHistorical