FDA.reportPublic FDA data

Fexofenadine Hydrochloride

Product NDC
0615-7696
11-digit product format
006157696
Labeler code
0615
Product ID
0615-7696_c556a3da-dd66-4f9c-9514-98c68e2d6e75
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, Inc dba Vangard Labs
Application
ANDA076447
Marketing category
ANDA
Marketing start
2011-04-22
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0615-7696DDiscontinued by firm2026-07-31
excluded packagepackage0615-76960615-7696-39DDiscontinued 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 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076447-001FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2005-09-01
A076447-002FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2005-09-01
A076447-003FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2005-09-01
A076447-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2011-04-13
A076447-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2011-04-13
A076447-006FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2011-04-13
A076447-007FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2011-04-13
A076447-008FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2011-04-13

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 22:54:322026-06A076447-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2005-09-01a50c72e98297…
2026-08-01 22:54:322026-06A076447-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2005-09-01a50c72e98297…
2026-08-01 22:54:322026-06A076447-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2005-09-01a50c72e98297…
2026-08-01 22:54:322026-06A076447-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-13a50c72e98297…
2026-08-01 22:54:322026-06A076447-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-13a50c72e98297…
2026-08-01 22:54:322026-06A076447-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-13a50c72e98297…
2026-08-01 22:54:322026-06A076447-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-13a50c72e98297…
2026-08-01 22:54:322026-06A076447-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-13a50c72e98297…

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
CareOne Allergy ReliefFEXOFENADINE HCLAmerican Sales Company65720e72-c20d-4363-92ab-76596e043bc02021-07-12WarningsExact identifier
application applno (ANDA): 076447
application number: ANDA076447

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0615-7696-392021-05-14C16284748780-197449f38-c3b9-f6ea-e053-dbdaa90aa703Fexofenadine HCI 180mg
0615-7696-392019-11-13C16284748780-197449f38-c3b9-f6ea-e053-dbdaa90aa703Fexofenadine HCI 180mg

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2