Home NDC 46122-779 FEXOFENADINE HYDROCHLORIDE
Product NDC 46122-779
11-digit product format 461220779
Labeler code 46122
Product ID 46122-779_76ea7e25-e968-4c78-9eca-ac960ad55985
Type HUMAN OTC DRUG
Nonproprietary name FEXOFENADINE HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AMERISOURCE BERGEN
Application ANDA091567
Marketing category ANDA
Marketing start 2024-05-14
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 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091567-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2012-02-06 A091567-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2012-02-06 A091567-003 FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2012-02-06 A091567-004 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2012-02-06 A091567-005 FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2012-02-06 A091567-006 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2012-02-06
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 7 · 252 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 A091567-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2012-02-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091567-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2012-02-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091567-003 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2012-02-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091567-004 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2012-02-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091567-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2012-02-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091567-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2012-02-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091567-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2012-02-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091567-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2012-02-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091567-003 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2012-02-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091567-004 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2012-02-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091567-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2012-02-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091567-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2012-02-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091567-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2012-02-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091567-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2012-02-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091567-003 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2012-02-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091567-004 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2012-02-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091567-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2012-02-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091567-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2012-02-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091567-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2012-02-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091567-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2012-02-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091567-003 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2012-02-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091567-004 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2012-02-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091567-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2012-02-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091567-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2012-02-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091567-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2012-02-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091567-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2012-02-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091567-003 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2012-02-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091567-004 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2012-02-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091567-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2012-02-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091567-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2012-02-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091567-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2012-02-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091567-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2012-02-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091567-003 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2012-02-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091567-004 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2012-02-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091567-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2012-02-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091567-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2012-02-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091567-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2012-02-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091567-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2012-02-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091567-003 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2012-02-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091567-004 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2012-02-06 03ed91905a0d…
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 46122-779-58 FEXOFENADINE HYDROCHLORIDE 5 in 1 BLISTER PACK TABLET, FILM COATED 5 1 46122-779-58 FEXOFENADINE HYDROCHLORIDE 3 in 1 CARTON TABLET, FILM COATED 3 1 46122-779-61 FEXOFENADINE HYDROCHLORIDE 30 in 1 BOTTLE TABLET, FILM COATED 30 1 46122-779-61 FEXOFENADINE HYDROCHLORIDE 1 in 1 CARTON TABLET, FILM COATED 1 1 46122-779-66 FEXOFENADINE HYDROCHLORIDE 90 in 1 BOTTLE TABLET, FILM COATED 90 1 46122-779-66 FEXOFENADINE HYDROCHLORIDE 1 in 1 CARTON TABLET, FILM COATED 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46122-779 FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AMERISOURCE BERGEN] 1 Current NDC, 6 package rows 20240518_2a578643-adc1-44ca-83f2-9d48527bd3a4.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 · 4 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 46122-779-58 46122077958 3 BLISTER PACK in 1 CARTON (46122-779-58) / 5 TABLET, FILM COATED in 1 BLISTER PACK 3 blister pack 2024-05-14 No No Current 46122-779-61 46122077961 1 BOTTLE in 1 CARTON (46122-779-61) / 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2024-05-14 No No Current 46122-779-66 46122077966 1 BOTTLE in 1 CARTON (46122-779-66) / 90 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2024-05-14 No No Current