Home NDC 68071-2615-9 fexofenadine hcl
Product NDC 68071-2615
Requested package NDC 68071-2615-9
11-digit product format 680712615
Labeler code 68071
Product ID 68071-2615_d56af305-df94-d9ec-e053-2995a90a22ea
Type HUMAN OTC DRUG
Nonproprietary name fexofenadine hcl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA204507
Marketing category ANDA
Marketing start 2021-08-26
Marketing end 0000-00-00
Substance FEXOFENADINE HYDROCHLORIDE
Active strength 60 mg/1
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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-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 · 172 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 2026-09-14 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…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204507-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2015-09-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204507-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2015-09-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204507-004 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2015-09-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204507-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2015-09-16 5bbf6a4d5a75…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-2615-9 fexofenadine hcl 90 in 1 BOTTLE TABLET, FILM COATED 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-2615 FEXOFENADINE HCL TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] 1 Legacy NDC, 1 package rows 20220113_d56af33f-189d-19c4-e053-2a95a90a1461.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 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 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
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 68071-2615-9 68071261509 90 TABLET, FILM COATED in 1 BOTTLE (68071-2615-9) 2022-01-12 0000-00-00 No No Current