Home NDC 72090-058-01 Gencare Hives Relief
Product NDC 72090-058
Requested package NDC 72090-058-01
11-digit product format 720900058
Labeler code 72090
Product ID 72090-058_bc8f944b-f445-42b6-b479-3d50623cd839
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 2026-01-21
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 2027-12-31
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 · 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 · 44 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 A210137-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2018-08-13 c2088c7a36db…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…
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 Gencare Hives Relief
Listing expiration 2027-12-31 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 72090-058-01 Gencare Hives Relief 48 in 1 BOTTLE TABLET 48 1
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 72090-058-01 72090005801 48 TABLET in 1 BOTTLE (72090-058-01) 48 tablet 2026-01-21 No No Current