Home NDC 84324-008 FEXOFENADINE HYDROCHLORIDE
Product NDC 84324-008
11-digit product format 843240008
Labeler code 84324
Product ID 84324-008_16dc8e4f-54e3-4edd-87f8-30d072fabad1
Type HUMAN OTC DRUG
Nonproprietary name FEXOFENADINE HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler NUVICARE LLC
Application ANDA210137
Marketing category ANDA
Marketing start 2024-07-17
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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2018-08-13
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 2 · 42 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 2026-08-18 06:07:40 2026-07 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base FEXOFENADINE HYDROCHLORIDE
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 84324-008-01 FEXOFENADINE HYDROCHLORIDE 18 in 1 BOTTLE TABLET 18 2 84324-008-02 FEXOFENADINE HYDROCHLORIDE 4 in 1 BLISTER PACK TABLET 4 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84324-008 FEXOFENADINE HYDROCHLORIDE TABLET [NUVICARE LLC] 1 Current NDC, 1 package rows 20240718_bb47b839-3f49-4818-a62c-b6d2b09b15dc.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 1 · 10 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84324-008-01 84324000801 18 TABLET in 1 BOTTLE (84324-008-01) 18 tablet 2024-07-17 No No Current 84324-008-02 84324000802 4 TABLET in 1 BLISTER PACK (84324-008-02) 4 tablet 2025-06-09 No No Current