FDA.reportPublic FDA data

Fexofenadine Hydrochloride

Product NDC
84324-045
Requested package NDC
84324-045-01
11-digit product format
843240045
Labeler code
84324
Product ID
84324-045_9af9c85f-e9d5-45f1-aaa8-488af705b2cc
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NUVICARE LLC
Application
ANDA204507
Marketing category
ANDA
Marketing start
2026-07-30
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
60 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA]; Histamine-1 Receptor Antagonist [EPC]
Listing certified through
2027-12-31
Current FDA listing
Yes

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-16a50c72e98297…
2026-08-01 22:54:322026-06A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-16a50c72e98297…
2026-08-01 22:54:322026-06A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-16a50c72e98297…
2026-08-01 22:54:322026-06A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-16a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
ndc (package): 84324-045-01
ndc (product): 84324-045
ndc11 (package): 84324004501
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

Additional Listing Data#

Finished product
Yes
Brand name base
Fexofenadine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2S068B75ZUInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
dd0da52b-fc82-4ec9-854c-0d7c52e926fbNot currently hydrated or indexed on FDA.report

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleStatus
84324-045-018432400450160 TABLET in 1 BOTTLE (84324-045-01)60 tablet2026-07-300Current