FEXOFENADINE HCL

Product NDC
76519-1182
11-digit product format
765191182
Labeler code
76519
Product ID
76519-1182_8c65af67-a4b1-41ee-e053-2995a90a4bea
Type
HUMAN OTC DRUG
Nonproprietary name
FEXOFENADINE HCL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA204507
Marketing category
ANDA
Marketing start
2018-03-26
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct76519-1182IInactivated by FDA2026-10-05
excluded packagepackage76519-118276519-1182-3IInactivated by FDA2026-10-05

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 packagepackage76519-1182-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76519-1182-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76519-1182-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76519-1182-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76519-1182-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76519-1182-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76519-1182-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76519-1182-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76519-1182-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76519-1182-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76519-1182-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76519-1182-3557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage76519-1182-38af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage76519-1182-3834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage76519-1182-31332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage76519-1182-3fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage76519-1182-386f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage76519-1182-3bd6a592717d7…303034d00443…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-1684e616aacf4f…
2026-09-14 22:38:342026-08A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-1684e616aacf4f…
2026-09-14 22:38:342026-08A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-1684e616aacf4f…
2026-09-14 22:38:342026-08A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-1684e616aacf4f…
2026-08-18 06:07:402026-07A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-16caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76519-1182-32022-01-28C16284748780-1d6a99b39-506e-a426-e053-dadaa90af4c21182 FEXOFENADINE HCL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76519-1182-3FEXOFENADINE HCL30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76519-1182FEXOFENADINE HCL TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 1 package rows20190629_8c65af67-a4b0-41ee-e053-2995a90a4bea.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-0d7c52e926fb2026-08-03WarningsExact 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 TabletPSN8c65af67-a4b0-41ee-e053-2995a90a4bea1
997420fexofenadine hydrochloride 180 MG Oral TabletSCD8c65af67-a4b0-41ee-e053-2995a90a4bea1
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY8c65af67-a4b0-41ee-e053-2995a90a4bea1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76519-1182-37651911820330 TABLET, FILM COATED in 1 BOTTLE (76519-1182-3) 2018-03-260000-00-00NoNoCurrent