Fexofenadine hydrochloride

Product NDC
42291-297
11-digit product format
422910297
Labeler code
42291
Product ID
42291-297_a8214928-6b62-9001-e053-2a95a90ab076
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA202039
Marketing category
ANDA
Marketing start
2015-05-01
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42291-297DDiscontinued by firm2026-08-03
excluded packagepackage42291-29742291-297-50DDiscontinued by firm2026-08-03
excluded packagepackage42291-29742291-297-90DDiscontinued by firm2026-08-03

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct42291-297DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42291-29742291-297-50DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42291-29742291-297-90DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproduct42291-297DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42291-29742291-297-50DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42291-29742291-297-90DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct42291-297DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42291-29742291-297-50DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42291-29742291-297-90DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproduct42291-297DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42291-29742291-297-50DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42291-29742291-297-90DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproduct42291-297DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42291-29742291-297-50DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42291-29742291-297-90DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproduct42291-297DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42291-29742291-297-50DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42291-29742291-297-90DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct42291-297DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42291-29742291-297-50DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42291-29742291-297-90DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct42291-297DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42291-29742291-297-50DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42291-29742291-297-90DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct42291-297DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42291-29742291-297-50DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42291-29742291-297-90DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproduct42291-297DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42291-29742291-297-50DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42291-29742291-297-90DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct42291-297DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42291-29742291-297-50DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42291-29742291-297-90DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct42291-297DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42291-29742291-297-50DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42291-29742291-297-90DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2014-11-19
A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2014-11-19
A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2014-11-19

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2014-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2014-11-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2014-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2014-11-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2014-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2014-11-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2014-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2014-11-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2014-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2014-11-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2014-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2014-11-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2014-11-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2014-11-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2014-11-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2014-11-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2014-11-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2014-11-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2014-11-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2014-11-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2014-11-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2014-11-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2014-11-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2014-11-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2014-11-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2014-11-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-198072bd15b7f6…

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
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDE7-elevend5914c05-e8db-4c79-82d0-a279d13041182019-06-20WarningsExact identifier
application applno (ANDA): 202039
application number: ANDA202039

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-297-50EA - Each42291-2972dbb54de-6644-4dce-a08b-ee787a79e71512015-06-09
42291-297-90EA - Each42291-29716cdf55d-63b5-49fd-a6f2-474c9570c17812015-06-09

DailyMed Socrata Ingredients#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-297-5042291029750500 TABLET, FILM COATED in 1 BOTTLE (42291-297-50) 2015-05-010000-00-00NoNoCurrent