Home NDC 72090-010-99 FEXOFENADINE HYDROCHLORIDE
Product NDC 72090-010
Requested package NDC 72090-010-99
11-digit product format 720900010
Labeler code 72090
Product ID 72090-010_2aa6e396-3103-48d1-bcd7-43b140549307
Type HUMAN OTC DRUG
Nonproprietary name FEXOFENADINE HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler Pioneer Life Sciences, LLC
Application ANDA210137
Marketing category ANDA
Marketing start 2023-12-07
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 43 .
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 · 43 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 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 84e616aacf4f…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…
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 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 72090-010-01 FEXOFENADINE HYDROCHLORIDE 90 in 1 BOTTLE TABLET 90 3 72090-010-02 FEXOFENADINE HYDROCHLORIDE 100 in 1 BOTTLE TABLET 100 3 72090-010-03 FEXOFENADINE HYDROCHLORIDE 50 in 1 BOTTLE TABLET 50 3 72090-010-04 FEXOFENADINE HYDROCHLORIDE 150 in 1 BOTTLE TABLET 150 3 72090-010-99 FEXOFENADINE HYDROCHLORIDE 1000 in 1 BOTTLE TABLET 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72090-010 FEXOFENADINE HYDROCHLORIDE TABLET [PIONEER LIFE SCIENCES, LLC] 2 Current NDC, 1 package rows 20241127_d3b6f04c-60d6-4ac3-9fb2-19eeb80f00a5.zip 72090-010 FEXOFENADINE HYDROCHLORIDE TABLET [PIONEER LIFE SCIENCES, LLC] 2 Current NDC, 1 package rows 20241127_d7fe71e4-aada-40f5-86a8-bf0d7eb9b851.zip 72090-010 FEXOFENADINE HYDROCHLORIDE TABLET [PIONEER LIFE SCIENCES, LLC] 2 Current NDC, 3 package rows 20241031_0a4f4178-bea5-4995-99dc-96980cccdc8a.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 72090-010-99 72090001099 1000 TABLET in 1 BOTTLE (72090-010-99) 1000 tablet 2023-08-11 No No Current