fexofenadine hydrochloride

Product NDC
45802-571
11-digit product format
458020571
Labeler code
45802
Product ID
45802-571_ee7c9445-aa35-4f84-8ba1-ceba369c42df
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA076447
Marketing category
ANDA
Marketing start
2011-04-22
Marketing end
2022-10-31
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct45802-571DDiscontinued by firm2026-08-11
excluded packagepackage45802-57145802-571-78DDiscontinued by firm2026-08-11
excluded packagepackage45802-57145802-571-87DDiscontinued by firm2026-08-11

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45802-571-87d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45802-571-78d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45802-571-87f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45802-571-78f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45802-571-872ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45802-571-782ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45802-571-87a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45802-571-78a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45802-571-87cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45802-571-78cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45802-571-87cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45802-571-78cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage45802-571-87302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage45802-571-78302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage45802-571-87ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage45802-571-78ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage45802-571-870efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage45802-571-780efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage45802-571-87ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage45802-571-78ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage45802-571-87367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage45802-571-78367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage45802-571-87557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage45802-571-78557ba5c1ecfa…9c80585c8c6e…

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.

Product history page 1 of 9 · 328 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076447-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2005-09-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076447-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2005-09-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076447-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2005-09-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076447-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076447-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076447-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076447-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076447-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2005-09-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2005-09-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2005-09-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A076447-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2005-09-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076447-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2005-09-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076447-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2005-09-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076447-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076447-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076447-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076447-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076447-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076447-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2005-09-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076447-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2005-09-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076447-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2005-09-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076447-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076447-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076447-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076447-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076447-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076447-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2005-09-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076447-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2005-09-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076447-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2005-09-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076447-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076447-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076447-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076447-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076447-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-13b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076447-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076447-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076447-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076447-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076447-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076447-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076447-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076447-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076447-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076447-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076447-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076447-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076447-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076447-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076447-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076447-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076447-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076447-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076447-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076447-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076447-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076447-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076447-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076447-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076447-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076447-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076447-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076447-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076447-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076447-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076447-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076447-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076447-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076447-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076447-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076447-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076447-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076447-001AB18072bd15b7f6…

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-571-78EA - Each45802-571834cc3e1-09bf-4d4e-83ef-1022b7a7595b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]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
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]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
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PERRIGO NEW YORK INC]1
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PERRIGO NEW YORK INC]1
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PERRIGO NEW YORK INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PERRIGO NEW YORK INC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PERRIGO NEW YORK INC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PERRIGO NEW YORK INC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PERRIGO NEW YORK INC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PERRIGO NEW YORK INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PERRIGO NEW YORK INC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PERRIGO NEW YORK INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PERRIGO NEW YORK INC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PERRIGO NEW YORK INC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PERRIGO NEW YORK INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PERRIGO NEW YORK INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN003b1c72-559d-43d6-9ecc-4675818fa23a4
997420fexofenadine hydrochloride 180 MG Oral TabletSCD003b1c72-559d-43d6-9ecc-4675818fa23a4
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY003b1c72-559d-43d6-9ecc-4675818fa23a4
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN2e698795-dd51-4fe6-bc2b-a36bd08decda3
997420fexofenadine hydrochloride 180 MG Oral TabletSCD2e698795-dd51-4fe6-bc2b-a36bd08decda3
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY2e698795-dd51-4fe6-bc2b-a36bd08decda3
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN2a7d8bc7-45a3-497a-aa88-d3a3490aef111
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN8b5effa8-7ee3-4188-8b3a-8b62d4282c761
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN8e02f9b6-d5ca-42aa-bdb3-c9367745b5cd1
997420fexofenadine hydrochloride 180 MG Oral TabletSCD2a7d8bc7-45a3-497a-aa88-d3a3490aef111
997420fexofenadine hydrochloride 180 MG Oral TabletSCD8b5effa8-7ee3-4188-8b3a-8b62d4282c761
997420fexofenadine hydrochloride 180 MG Oral TabletSCD8e02f9b6-d5ca-42aa-bdb3-c9367745b5cd1
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY2a7d8bc7-45a3-497a-aa88-d3a3490aef111
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY8b5effa8-7ee3-4188-8b3a-8b62d4282c761
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY8e02f9b6-d5ca-42aa-bdb3-c9367745b5cd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-571-78458020571781 BOTTLE in 1 CARTON (45802-571-78) > 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2011-04-220000-00-00NoNoCurrent