Home NDC 80513-506 Fexofenadine HCl
Product NDC 80513-506
11-digit product format 805130506
Labeler code 80513
Product ID 80513-506_21be7a92-2648-b2bf-e063-6394a90ac580
Type HUMAN OTC DRUG
Nonproprietary name Fexofenadine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Advanced Rx LLC
Application ANDA204507
Marketing category ANDA
Marketing start 2015-09-16
Substance FEXOFENADINE HYDROCHLORIDE
Active strength 180 mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204507-002 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2015-09-16 A204507-003 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2015-09-16 A204507-004 FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2015-09-16 A204507-005 FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2015-09-16
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A204507-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2015-09-16 a50c72e98297…2026-08-01 22:54:32 2026-06 A204507-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2015-09-16 a50c72e98297…2026-08-01 22:54:32 2026-06 A204507-004 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2015-09-16 a50c72e98297…2026-08-01 22:54:32 2026-06 A204507-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2015-09-16 a50c72e98297…
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fexofenadine Hydrochloride FEXOFENADINE HYDROCHLORIDE NUVICARE LLC dd0da52b-fc82-4ec9-854c-0d7c52e926fb 2026-07-30 Warnings Exact identifier application applno (ANDA): 204507 application number: ANDA204507 Allergy Relief FEXOFENADINE HCL P & L Development, LLC 35b807b5-2e7a-446b-b378-eb5391ddfd14 2026-07-22 Warnings Exact identifier application applno (ANDA): 204507 application number: ANDA204507 Curist Hives Relief FEXOFENADINE HYDROCHLORIDE 180 MG Little Pharma, Inc. 04c75e93-b1f4-2546-e063-6394a90af0e1 2026-07-15 Warnings Exact identifier application applno (ANDA): 204507 application number: ANDA204507 Gencare-Allergy Relief FEXOFENADINE HYDROCHLORIDE Pioneer Life Sciences, LLC a8595b29-1ea3-44aa-b131-030f34f408fc 2026-06-22 Warnings Exact identifier application applno (ANDA): 204507 application number: ANDA204507 Allergy Relief FEXOFENADINE HCL P & L Development, LLC a976ad95-33d2-49f5-bad5-e980bf764879 2026-06-08 Warnings Exact identifier application applno (ANDA): 204507 application number: ANDA204507 ALLERGY RELIEF FEXOFENADINE HYDROCHLORIDE YYBA CORP 2dd5e6b0-2445-4419-b0e6-c62aadee6ea4 2026-03-18 Warnings Exact identifier application applno (ANDA): 204507 application number: ANDA204507 fexofenadine hcl FEXOFENADINE HCL AKRON PHARMA INC fe67f0f1-c6f1-424e-8226-19176de79945 2026-01-19 Warnings Exact identifier application applno (ANDA): 204507 application number: ANDA204507 Fexofenadine Hydrochloride FEXOFENADINE HCL Northwind Health Company, LLC f2b6c157-1af1-8d43-e053-2995a90aaf1a 2026-01-01 Warnings Exact identifier application applno (ANDA): 204507 application number: ANDA204507 ALLERGY RELIEF FEXOFENADINE HYDROCHLORIDE YYBA CORP a1e80757-346f-4d88-8da7-55583c3a902b 2025-11-26 Warnings Exact identifier application applno (ANDA): 204507 application number: ANDA204507 fexofenadine hcl FEXOFENADINE HCL Bryant Ranch Prepack c23ad304-a5de-454e-a135-4eb143af2381 2025-10-22 Warnings Exact identifier application applno (ANDA): 204507 application number: ANDA204507 IAllergy Relief FEXOFENADINE HCL Safeway, Inc. 1f6a97e3-f84a-4c89-8e8f-6e0d111fe500 2025-08-19 Warnings Exact identifier application applno (ANDA): 204507 application number: ANDA204507 fexofenadine hcl FEXOFENADINE HCL Major Pharmaceuticals 107f398c-f296-4190-8234-82556a039e65 2025-08-12 Warnings Exact identifier application applno (ANDA): 204507 application number: ANDA204507 Fexofenadine Hydrochloride FEXOFENADINE HCL Major Pharmaceuticals c34cda59-8a63-48ab-a19d-c06a1878f5da 2025-07-18 Warnings Exact identifier application applno (ANDA): 204507 application number: ANDA204507 Allergy Relief non drowsy FEXOFENADINE HCL MEIJER, INC. b3395454-65db-4d8b-abce-2475b049a114 2025-07-02 Warnings Exact identifier application applno (ANDA): 204507 application number: ANDA204507 fexofenadine hcl FEXOFENADINE HCL Aphena Pharma Solutions - Tennessee, LLC 34918a5a-c4c9-bc79-e063-6294a90acb85 2025-05-13 Warnings Exact identifier application applno (ANDA): 204507 application number: ANDA204507 ALLERGY RELIEF FEXOFENADINE HCL Bi-Mart ea8d8e12-4781-4501-a887-e732295d33bf 2025-04-28 Warnings Exact identifier application applno (ANDA): 204507 application number: ANDA204507 fexofenadine hcl FEXOFENADINE HCL Aphena Pharma Solutions - Tennessee, LLC 31e71ee7-c4b5-6c1c-e063-6294a90a1513 2025-04-03 Warnings Exact identifier application applno (ANDA): 204507 application number: ANDA204507 fexofenadine hcl FEXOFENADINE HCL Radha Pharmaceuticals 30283df1-6394-3a91-e063-6394a90a6776 2025-03-10 Warnings Exact identifier application applno (ANDA): 204507 application number: ANDA204507 fexofenadine hcl FEXOFENADINE HCL ScieGen Pharmaceuticals, Inc. b7e9477d-33d9-4463-b8a6-69af5f71ce35 2024-12-24 Warnings Exact identifier application applno (ANDA): 204507 application number: ANDA204507 Fexofenadine Hydrochloride FEXOFENADINE HYDROCHLORIDE SPIRIT PHARMACEUTICALS LLC 5307b7ef-0c22-4aae-a2f6-033d31032f55 2024-12-13 Warnings Exact identifier application applno (ANDA): 204507 application number: ANDA204507
Additional Listing Data#
Finished product Yes
Brand name base Fexofenadine HCl
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FEXOFENADINE HYDROCHLORIDE 180 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2S068B75ZU Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 997420 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80513-506-01 Fexofenadine HCl 100 in 1 BOTTLE TABLET, FILM COATED 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80513-506 FEXOFENADINE HCL TABLET, FILM COATED [ADVANCED RX LLC] 1 Current NDC, 1 package rows 20240912_c067b335-79c5-4176-a0b3-bae02a0c23f8.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 80513-506-01 80513050601 100 TABLET, FILM COATED in 1 BOTTLE (80513-506-01) 2024-09-10 No No Current