Home NDC 73581-012 Fexofenadine
Product NDC 73581-012
11-digit product format 735810012
Labeler code 73581
Product ID 73581-012_579c7ff9-0c45-1d46-e063-6294a90aef34
Type HUMAN OTC DRUG
Nonproprietary name Fexofenadine
Dosage form TABLET
Route ORAL
Labeler YYBA Corp
Application ANDA219032
Marketing category ANDA
Marketing start 2026-07-27
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 2027-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219032-001 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2025-02-28 A219032-002 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2025-02-28
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.
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 A219032-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2025-02-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219032-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2025-02-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219032-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2025-02-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219032-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2025-02-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219032-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2025-02-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219032-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2025-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219032-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2025-02-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219032-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2025-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219032-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2025-02-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219032-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2025-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219032-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2025-02-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219032-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2025-02-28 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219032-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2025-02-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219032-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2025-02-28 a50c72e98297…
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
Listing expiration 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 997501 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 73581-012-01 73581001201 100 TABLET in 1 BOTTLE (73581-012-01) 100 tablet 2026-09-01 No No Current 73581-012-02 73581001202 200 TABLET in 1 BOTTLE (73581-012-02) 200 tablet 2026-09-01 No No Current 73581-012-06 73581001206 60 TABLET in 1 BOTTLE (73581-012-06) 60 tablet 2026-09-01 No No Current