FDA.reportPublic FDA data

Fexofenadine HCl

Product NDC
61715-049
11-digit product format
617150049
Labeler code
61715
Product ID
61715-049_e6ab3e06-52e9-472e-9960-b1a17ab92db8
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Plus (Kinray)
Application
ANDA079112
Marketing category
ANDA
Marketing start
2013-03-31
Marketing end
2019-12-31
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61715-049DDiscontinued by firm2026-07-31
excluded packagepackage61715-04961715-049-30DDiscontinued by firm2026-07-31

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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE HCL TABLET [PREFERRED PLUS (KINRAY)]1
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE HCL TABLET [PREFERRED PLUS (KINRAY)]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFEXOFENADINE HCL TABLET [PREFERRED PLUS (KINRAY)]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FEXOFENADINE HCL TABLET [PREFERRED PLUS (KINRAY)]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FEXOFENADINE HCL TABLET [PREFERRED PLUS (KINRAY)]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFEXOFENADINE HCL TABLET [PREFERRED PLUS (KINRAY)]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEXOFENADINE HCL TABLET [PREFERRED PLUS (KINRAY)]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFEXOFENADINE HCL TABLET [PREFERRED PLUS (KINRAY)]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEXOFENADINE HCL TABLET [PREFERRED PLUS (KINRAY)]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFEXOFENADINE HCL TABLET [PREFERRED PLUS (KINRAY)]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EFEXOFENADINE HCL TABLET [PREFERRED PLUS (KINRAY)]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FEXOFENADINE HCL TABLET [PREFERRED PLUS (KINRAY)]1
TALCINACTIVE INGREDIENT7SEV7J4R1UFEXOFENADINE HCL TABLET [PREFERRED PLUS (KINRAY)]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXOFENADINE HCL TABLET [PREFERRED PLUS (KINRAY)]1