FDA.reportPublic FDA data

ALLERGY 24-HR

Product NDC
64679-744
11-digit product format
646790744
Labeler code
64679
Product ID
64679-744_f0f5c363-88c5-7177-e053-2a95a90a1a78
Type
HUMAN OTC DRUG
Nonproprietary name
FEXOFENADINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wockhardt USA LLC.
Application
ANDA079112
Marketing category
ANDA
Marketing start
2012-02-08
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct64679-744DDiscontinued by firm2026-07-31
excluded productproduct64679-744IInactivated by FDA2026-07-31
excluded packagepackage64679-74464679-744-09DDiscontinued by firm2026-07-31
excluded packagepackage64679-74464679-744-07IInactivated 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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079112-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2012-02-08
A079112-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2012-02-08
A079112-003FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2012-02-08
A079112-004FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2012-02-08
A079112-005FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2012-02-08
A079112-006FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2012-02-08

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 22:54:322026-06A079112-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2012-02-08a50c72e98297…
2026-08-01 22:54:322026-06A079112-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2012-02-08a50c72e98297…
2026-08-01 22:54:322026-06A079112-003FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2012-02-08a50c72e98297…
2026-08-01 22:54:322026-06A079112-004FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2012-02-08a50c72e98297…
2026-08-01 22:54:322026-06A079112-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2012-02-08a50c72e98297…
2026-08-01 22:54:322026-06A079112-006FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2012-02-08a50c72e98297…

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
64679-744-092025-12-12C16284748780-11030e365-3768-111a-e063-dadaa90a10e2ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-744-092024-01-30C16284748780-11030e365-3768-111a-e063-dadaa90a10e2ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-744-072020-01-31C16284748780-19d75b9d1-1adf-f424-e053-dadaa90a57ceFexofenadine Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64679-744-06Fexofenadine6 in 1 BLISTER PACKTABLET, FILM COATED61
64679-744-07Fexofenadine1 in 1 CARTONTABLET, FILM COATED11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]1
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64679-744ALLERGY 24-HR (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [WOCKHARDT USA LLC.]8Legacy NDC20221230_f4b394a6-8b4d-41ac-8962-82e81d85dd90.zip
64679-744FEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]1Legacy NDC, 2 package rows20120404_9a5da651-483e-4e51-b822-12465930fa5c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN9a5da651-483e-4e51-b822-12465930fa5c1
997488fexofenadine HCl 30 MG Oral TabletPSN9a5da651-483e-4e51-b822-12465930fa5c1
997501fexofenadine HCl 60 MG Oral TabletPSN9a5da651-483e-4e51-b822-12465930fa5c1
997420fexofenadine hydrochloride 180 MG Oral TabletSCD9a5da651-483e-4e51-b822-12465930fa5c1
997488fexofenadine hydrochloride 30 MG Oral TabletSCD9a5da651-483e-4e51-b822-12465930fa5c1
997501fexofenadine hydrochloride 60 MG Oral TabletSCD9a5da651-483e-4e51-b822-12465930fa5c1
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY9a5da651-483e-4e51-b822-12465930fa5c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64679-744-06646790744066 in 1 BLISTER PACKHistorical
64679-744-07646790744071 in 1 CARTONHistorical
64679-744-09646790744091 BLISTER PACK in 1 CARTON (64679-744-09) > 6 TABLET, FILM COATED in 1 BLISTER PACK (64679-744-08) 1 blister pack2012-02-080000-00-00NoNoCurrent