Home NDC 69230-201 Fexofenadine HCl
Product NDC 69230-201
11-digit product format 692300201
Labeler code 69230
Product ID 69230-201_09845f21-f05e-34b2-e063-6394a90a7677
Type HUMAN OTC DRUG
Nonproprietary name Fexofenadine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Camber Consumer Care
Application ANDA204507
Marketing category ANDA
Marketing start 2021-12-08
Substance FEXOFENADINE HYDROCHLORIDE
Active strength 60 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 44 .
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.
Product history page 1 of 5 · 176 observed 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 2026-10-15 13:18:30 2026-09 A204507-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2015-09-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 A204507-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2015-09-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 A204507-004 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2015-09-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 A204507-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2015-09-16 c2088c7a36db…2026-09-14 22:38:34 2026-08 A204507-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2015-09-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204507-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2015-09-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204507-004 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2015-09-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204507-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2015-09-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204507-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2015-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204507-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2015-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204507-004 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2015-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204507-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2015-09-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204507-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2015-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204507-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2015-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204507-004 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2015-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204507-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2015-09-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204507-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2015-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204507-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2015-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204507-004 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2015-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204507-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2015-09-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204507-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2015-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204507-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2015-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204507-004 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2015-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204507-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2015-09-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204507-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2015-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204507-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2015-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204507-004 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2015-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204507-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2015-09-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204507-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2015-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204507-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2015-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204507-004 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2015-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204507-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2015-09-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204507-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2015-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204507-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2015-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204507-004 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2015-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204507-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2015-09-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204507-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2015-09-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204507-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2015-09-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204507-004 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2015-09-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204507-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2015-09-16 2680178bc6a6…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 60 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 997420 Internal RxNorm lookup 997501 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 69230-201-01 Fexofenadine HCl 100 in 1 BOTTLE TABLET, FILM COATED 100 3 69230-201-05 Fexofenadine HCl 500 in 1 BOTTLE TABLET, FILM COATED 500 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69230-201 FEXOFENADINE HCL TABLET, FILM COATED [CAMBER CONSUMER CARE] 3 Current NDC, Legacy NDC, 2 package rows 20231108_1bb1bea3-b17d-4326-b037-7468add0df80.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 · 27 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 2026-08-03 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 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 Fexofenadine Hydrochloride FEXOFENADINE HYDROCHLORIDE SPIRIT PHARMACEUTICALS LLC ae0f16f6-d07a-47e1-adb8-07803c6cfb13 2024-12-13 Warnings Exact identifier application applno (ANDA): 204507 application number: ANDA204507
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 69230-201-01 69230020101 100 TABLET, FILM COATED in 1 BOTTLE (69230-201-01) 2021-12-08 No No Current 69230-201-05 69230020105 500 TABLET, FILM COATED in 1 BOTTLE (69230-201-05) 2021-12-08 0000-00-00 No No Current