Fexofenadine HCl

Product NDC
59779-979
11-digit product format
597790979
Labeler code
59779
Product ID
59779-979_b9bd6779-8514-49a7-afc2-ed767377fdfb
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA204507
Marketing category
ANDA
Marketing start
2015-09-16
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59779-979IInactivated by FDA2026-08-07
excluded packagepackage59779-97959779-979-30IInactivated by FDA2026-08-07
excluded packagepackage59779-97959779-979-45IInactivated by FDA2026-08-07
excluded packagepackage59779-97959779-979-53IInactivated by FDA2026-08-07
excluded packagepackage59779-97959779-979-73IInactivated by FDA2026-08-07
excluded packagepackage59779-97959779-979-81IInactivated by FDA2026-08-07
excluded packagepackage59779-97959779-979-83IInactivated by FDA2026-08-07
excluded packagepackage59779-97959779-979-90IInactivated by FDA2026-08-07

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 3 · 168 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 packagepackage59779-979-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59779-979-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59779-979-81d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59779-979-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59779-979-53d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59779-979-83d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59779-979-73d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59779-979-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59779-979-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59779-979-81f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59779-979-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59779-979-53f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59779-979-83f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59779-979-73f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59779-979-452ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59779-979-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59779-979-812ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59779-979-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59779-979-532ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59779-979-832ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59779-979-732ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59779-979-45a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59779-979-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59779-979-81a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59779-979-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59779-979-53a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59779-979-83a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59779-979-73a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59779-979-45cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59779-979-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59779-979-81cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59779-979-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59779-979-53cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59779-979-83cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59779-979-73cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59779-979-45cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59779-979-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59779-979-81cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59779-979-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59779-979-53cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59779-979-83cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59779-979-73cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59779-979-45302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59779-979-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59779-979-81302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59779-979-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59779-979-53302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59779-979-83302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59779-979-73302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59779-979-45ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59779-979-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59779-979-81ed331223b511…672a5bd82f5f…

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2015-09-16
A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2015-09-16
A204507-004FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2015-09-16
A204507-005FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2015-09-16

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-16d06236e962d9…

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-979-30Fexofenadine HCl30 in 1 CARTONTABLET, FILM COATED301
59779-979-45Fexofenadine HCl45 in 1 CARTONTABLET, FILM COATED451
59779-979-53Fexofenadine HCl180 in 1 CARTONTABLET, FILM COATED1801
59779-979-73Fexofenadine HCl60 in 1 CARTONTABLET, FILM COATED601
59779-979-81Fexofenadine HCl5 in 1 BLISTER PACKTABLET, FILM COATED51
59779-979-81Fexofenadine HCl1 in 1 CARTONTABLET, FILM COATED11
59779-979-83Fexofenadine HCl3 in 1 CARTONTABLET, FILM COATED31
59779-979-83Fexofenadine HCl5 in 1 BLISTER PACKTABLET, FILM COATED51
59779-979-90Fexofenadine HCl90 in 1 CARTONTABLET, FILM COATED901

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE HCL TABLET, FILM COATED [CVS PHARMACY]1
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE HCL TABLET, FILM COATED [CVS PHARMACY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKFEXOFENADINE HCL TABLET, FILM COATED [CVS PHARMACY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FEXOFENADINE HCL TABLET, FILM COATED [CVS PHARMACY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FEXOFENADINE HCL TABLET, FILM COATED [CVS PHARMACY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FEXOFENADINE HCL TABLET, FILM COATED [CVS PHARMACY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFEXOFENADINE HCL TABLET, FILM COATED [CVS PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEXOFENADINE HCL TABLET, FILM COATED [CVS PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFEXOFENADINE HCL TABLET, FILM COATED [CVS PHARMACY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFEXOFENADINE HCL TABLET, FILM COATED [CVS PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFEXOFENADINE HCL TABLET, FILM COATED [CVS PHARMACY]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APFEXOFENADINE HCL TABLET, FILM COATED [CVS PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXOFENADINE HCL TABLET, FILM COATED [CVS PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-979FEXOFENADINE HCL TABLET, FILM COATED [CVS PHARMACY]1Legacy NDC, 9 package rows20151022_e7c4a402-09ca-4f95-86fa-20b6117facb3.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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDENUVICARE LLCdd0da52b-fc82-4ec9-854c-0d7c52e926fb2026-07-30WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
Allergy ReliefFEXOFENADINE HCLP & L Development, LLC35b807b5-2e7a-446b-b378-eb5391ddfd142026-07-22WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
Curist Hives ReliefFEXOFENADINE HYDROCHLORIDE 180 MGLittle Pharma, Inc.04c75e93-b1f4-2546-e063-6394a90af0e12026-07-15WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
Gencare-Allergy ReliefFEXOFENADINE HYDROCHLORIDEPioneer Life Sciences, LLCa8595b29-1ea3-44aa-b131-030f34f408fc2026-06-22WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
Allergy ReliefFEXOFENADINE HCLP & L Development, LLCa976ad95-33d2-49f5-bad5-e980bf7648792026-06-08WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
ALLERGY RELIEFFEXOFENADINE HYDROCHLORIDEYYBA CORP2dd5e6b0-2445-4419-b0e6-c62aadee6ea42026-03-18WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
fexofenadine hclFEXOFENADINE HCLAKRON PHARMA INCfe67f0f1-c6f1-424e-8226-19176de799452026-01-19WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
Fexofenadine HydrochlorideFEXOFENADINE HCLNorthwind Health Company, LLCf2b6c157-1af1-8d43-e053-2995a90aaf1a2026-01-01WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
ALLERGY RELIEFFEXOFENADINE HYDROCHLORIDEYYBA CORPa1e80757-346f-4d88-8da7-55583c3a902b2025-11-26WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
fexofenadine hclFEXOFENADINE HCLBryant Ranch Prepackc23ad304-a5de-454e-a135-4eb143af23812025-10-22WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
IAllergy ReliefFEXOFENADINE HCLSafeway, Inc.1f6a97e3-f84a-4c89-8e8f-6e0d111fe5002025-08-19WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
fexofenadine hclFEXOFENADINE HCLMajor Pharmaceuticals107f398c-f296-4190-8234-82556a039e652025-08-12WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
Fexofenadine HydrochlorideFEXOFENADINE HCLMajor Pharmaceuticalsc34cda59-8a63-48ab-a19d-c06a1878f5da2025-07-18WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
Allergy Relief non drowsyFEXOFENADINE HCLMEIJER, INC.b3395454-65db-4d8b-abce-2475b049a1142025-07-02WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
fexofenadine hclFEXOFENADINE HCLAphena Pharma Solutions - Tennessee, LLC34918a5a-c4c9-bc79-e063-6294a90acb852025-05-13WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
ALLERGY RELIEFFEXOFENADINE HCLBi-Martea8d8e12-4781-4501-a887-e732295d33bf2025-04-28WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
fexofenadine hclFEXOFENADINE HCLAphena Pharma Solutions - Tennessee, LLC31e71ee7-c4b5-6c1c-e063-6294a90a15132025-04-03WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
fexofenadine hclFEXOFENADINE HCLRadha Pharmaceuticals30283df1-6394-3a91-e063-6394a90a67762025-03-10WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
fexofenadine hclFEXOFENADINE HCLScieGen Pharmaceuticals, Inc.b7e9477d-33d9-4463-b8a6-69af5f71ce352024-12-24WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDESPIRIT PHARMACEUTICALS LLC5307b7ef-0c22-4aae-a2f6-033d31032f552024-12-13WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNe7c4a402-09ca-4f95-86fa-20b6117facb31
997420fexofenadine hydrochloride 180 MG Oral TabletSCDe7c4a402-09ca-4f95-86fa-20b6117facb31
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYe7c4a402-09ca-4f95-86fa-20b6117facb31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
59779-979-305977909793030 in 1 CARTONHistorical
59779-979-455977909794545 in 1 CARTONHistorical
59779-979-5359779097953180 in 1 CARTONHistorical
59779-979-735977909797360 in 1 CARTONHistorical
59779-979-81597790979815 in 1 BLISTER PACKHistorical
59779-979-83597790979833 in 1 CARTONHistorical
59779-979-905977909799090 in 1 CARTONHistorical