FDA.reportPublic FDA data

FEXOFENADINE HYDROCHLORIDE

Product NDC
62756-543
Requested package NDC
62756-543-74
11-digit product format
627560543
Labeler code
62756
Product ID
62756-543_754f554d-91c6-4314-870c-b87e9a386153
Type
HUMAN OTC DRUG
Nonproprietary name
FEXOFENADINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA091567
Marketing category
ANDA
Marketing start
2012-02-06
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
60 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage62756-54362756-543-74IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A091567-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2012-02-06
A091567-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2012-02-06
A091567-003FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2012-02-06
A091567-004FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2012-02-06
A091567-005FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2012-02-06
A091567-006FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2012-02-06

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.

Product history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091567-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2012-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091567-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2012-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091567-003FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2012-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091567-004FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2012-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091567-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2012-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091567-006FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2012-02-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091567-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2012-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091567-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2012-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091567-003FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2012-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091567-004FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2012-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091567-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2012-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091567-006FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2012-02-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A091567-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2012-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091567-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2012-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091567-003FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2012-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091567-004FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2012-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091567-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2012-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091567-006FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2012-02-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091567-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2012-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091567-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2012-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091567-003FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2012-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091567-004FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2012-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091567-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2012-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091567-006FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2012-02-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091567-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2012-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091567-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2012-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091567-003FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2012-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091567-004FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2012-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091567-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2012-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091567-006FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2012-02-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091567-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2012-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091567-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2012-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091567-003FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2012-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091567-004FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2012-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091567-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2012-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091567-006FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2012-02-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091567-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2012-02-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091567-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2012-02-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091567-003FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2012-02-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091567-004FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2012-02-062680178bc6a6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
62756-543-64Fexofenadine Hydrochloride Tablets, USP
62756-543-66Fexofenadine Hydrochloride Tablets, USP
62756-543-74Fexofenadine Hydrochloride Tablets, USP
62756-543-76Fexofenadine Hydrochloride Tablets, USP
62756-543-77Fexofenadine Hydrochloride Tablets, USP
62756-543-78Fexofenadine Hydrochloride Tablets, USP
62756-543-83Fexofenadine Hydrochloride Tablets, USP
62756-543-88Fexofenadine Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62756-543-64FEXOFENADINE HYDROCHLORIDE5 in 1 CARTONTABLET, FILM COATED56
62756-543-64FEXOFENADINE HYDROCHLORIDE6 in 1 BLISTER PACKTABLET, FILM COATED66
62756-543-66FEXOFENADINE HYDROCHLORIDE5 in 1 BLISTER PACKTABLET, FILM COATED56
62756-543-66FEXOFENADINE HYDROCHLORIDE2 in 1 CARTONTABLET, FILM COATED26
62756-543-74FEXOFENADINE HYDROCHLORIDE5 in 1 BLISTER PACKTABLET, FILM COATED56
62756-543-74FEXOFENADINE HYDROCHLORIDE1 in 1 CARTONTABLET, FILM COATED16
62756-543-76FEXOFENADINE HYDROCHLORIDE10 in 1 CARTONTABLET, FILM COATED106
62756-543-76FEXOFENADINE HYDROCHLORIDE6 in 1 BLISTER PACKTABLET, FILM COATED66
62756-543-77FEXOFENADINE HYDROCHLORIDE5 in 1 BLISTER PACKTABLET, FILM COATED56
62756-543-77FEXOFENADINE HYDROCHLORIDE9 in 1 CARTONTABLET, FILM COATED96
62756-543-78FEXOFENADINE HYDROCHLORIDE6 in 1 BLISTER PACKTABLET, FILM COATED66
62756-543-78FEXOFENADINE HYDROCHLORIDE15 in 1 CARTONTABLET, FILM COATED156
62756-543-83FEXOFENADINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED306
62756-543-88FEXOFENADINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1006

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-543FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]6Legacy NDC, 14 package rows20181026_04923af6-97fc-4e32-834d-1df643832d7f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs58193632-2468-4159-b1a9-c24a489f199f2026-06-24WarningsExact identifier
application applno (ANDA): 091567
application number: ANDA091567
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDEOHM LABORATORIES INC.1a1afa95-570d-456e-b436-a0fcfaf685172026-05-05WarningsExact identifier
application applno (ANDA): 091567
application number: ANDA091567
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDECVS PHARMACY, INC7bc13851-291a-4582-8261-13c5022fbdd12024-05-24WarningsExact identifier
application applno (ANDA): 091567
application number: ANDA091567
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDEAMERISOURCE BERGEN2a578643-adc1-44ca-83f2-9d48527bd3a42024-05-14WarningsExact identifier
application applno (ANDA): 091567
application number: ANDA091567

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN04923af6-97fc-4e32-834d-1df643832d7f6
997488fexofenadine HCl 30 MG Oral TabletPSN04923af6-97fc-4e32-834d-1df643832d7f6
997501fexofenadine HCl 60 MG Oral TabletPSN04923af6-97fc-4e32-834d-1df643832d7f6
997420fexofenadine hydrochloride 180 MG Oral TabletSCD04923af6-97fc-4e32-834d-1df643832d7f6
997488fexofenadine hydrochloride 30 MG Oral TabletSCD04923af6-97fc-4e32-834d-1df643832d7f6
997501fexofenadine hydrochloride 60 MG Oral TabletSCD04923af6-97fc-4e32-834d-1df643832d7f6
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY04923af6-97fc-4e32-834d-1df643832d7f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62756-543-74627560543741 BLISTER PACK in 1 CARTON (62756-543-74) > 5 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2012-02-060000-00-00NoNoCurrent