Fexofenadine Hydrochloride

Product NDC
0378-0782
11-digit product format
003780782
Labeler code
0378
Product ID
0378-0782_f35905cb-7f58-41f1-a851-403032789d14
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA077081
Marketing category
ANDA
Marketing start
2011-08-25
Marketing end
2022-02-28
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#

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 productproduct0378-0782DDiscontinued by firm2026-08-17
excluded packagepackage0378-07820378-0782-05DDiscontinued by firm2026-08-17
excluded packagepackage0378-07820378-0782-93DDiscontinued by firm2026-08-17

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 packagepackage0378-0782-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0378-0782-93d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0378-0782-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0378-0782-93f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0378-0782-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0378-0782-932ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0378-0782-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0378-0782-93a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0378-0782-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0378-0782-93cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0378-0782-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0378-0782-93cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0378-0782-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0378-0782-93302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0378-0782-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0378-0782-93ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0378-0782-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0378-0782-930efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0378-0782-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0378-0782-93ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0378-0782-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0378-0782-93367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0378-0782-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0378-0782-93557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077081-001FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2007-04-16
A077081-002FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2008-04-11
A077081-003FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2008-04-11
A077081-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2011-07-21
A077081-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2011-07-21
A077081-006FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2011-07-21
A077081-007FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2011-07-21
A077081-008FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2011-07-21
A077081-009FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2011-07-21

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 10 · 378 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077081-001FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2007-04-16caaa826d4ba7…
2026-08-18 06:07:402026-07A077081-002FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2008-04-11caaa826d4ba7…
2026-08-18 06:07:402026-07A077081-003FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2008-04-11caaa826d4ba7…
2026-08-18 06:07:402026-07A077081-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-07-21caaa826d4ba7…
2026-08-18 06:07:402026-07A077081-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-07-21caaa826d4ba7…
2026-08-18 06:07:402026-07A077081-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-07-21caaa826d4ba7…
2026-08-18 06:07:402026-07A077081-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-07-21caaa826d4ba7…
2026-08-18 06:07:402026-07A077081-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-07-21caaa826d4ba7…
2026-08-18 06:07:402026-07A077081-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-07-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077081-001FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2007-04-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077081-002FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2008-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077081-003FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2008-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077081-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077081-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077081-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077081-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077081-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077081-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-07-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-001FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2007-04-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-002FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2008-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-003FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2008-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-07-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077081-001FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2007-04-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077081-002FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2008-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077081-003FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2008-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077081-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-07-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077081-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-07-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077081-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-07-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077081-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-07-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077081-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-07-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077081-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-07-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077081-001FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2007-04-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077081-002FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2008-04-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077081-003FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2008-04-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077081-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-07-21fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077081-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077081-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077081-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077081-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077081-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077081-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077081-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077081-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077081-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077081-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077081-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077081-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077081-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077081-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077081-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077081-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077081-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077081-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077081-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077081-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077081-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077081-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077081-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077081-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077081-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077081-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077081-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077081-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077081-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077081-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077081-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077081-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077081-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077081-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077081-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077081-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077081-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077081-003AB1782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0782-05EA - Each0378-07823fe6c6e2-d32d-4bd6-b729-b96836b92ba612012-07-24
0378-0782-93EA - Each0378-0782c464c35e-8ecf-4f93-9c1c-077c0c71e27612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
TRIACETININACTIVE INGREDIENTXHX3C3X673FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]2
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]2
TRIACETININACTIVE INGREDIENTXHX3C3X673FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-0782-0500378078205500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0782-05) 2011-08-250000-00-00NoNoCurrent
0378-0782-930037807829330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0782-93) 2011-08-252022-02-28NoNoCurrent