fexofenadine hcl

Product NDC
71610-070
Requested package NDC
71610-070-30
11-digit product format
716100070
Labeler code
71610
Product ID
71610-070_c95ab4c6-4665-4554-91fe-98aec928f628
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hcl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA204507
Marketing category
ANDA
Marketing start
2018-01-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71610-07071610-070-30DDiscontinued by firm2026-10-05

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 · 2 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 packagepackage71610-07071610-070-30DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71610-07071610-070-30DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-070FEXOFENADINE HCL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20180602_b7bcde69-6f97-4fd9-9137-bfc170a51f00.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-070-307161000703030 TABLET, FILM COATED in 1 BOTTLE (71610-070-30) 2018-05-180000-00-00NoNoCurrent