Home NDC 0904-5961 Fexofenadine Hydrochloride
Product NDC 0904-5961
11-digit product format 009045961
Labeler code 0904
Product ID 0904-5961_42579609-eccc-473c-8dd9-a94b94a74832
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fexofenadine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA076502
Marketing category ANDA
Marketing start 2009-06-10
Marketing end 0000-00-00
Substance FEXOFENADINE HYDROCHLORIDE
Active strength 30 mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 26 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0904-5961-61 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0904-5961-61 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0904-5961-61 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0904-5961-61 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0904-5961-61 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0904-5961-61 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0904-5961-61 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0904-5961-61 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0904-5961-61 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0904-5961-61 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0904-5961-61 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0904-5961-61 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0904-5961-61 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 9 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076502-001 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2006-04-11 A076502-002 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2006-04-11 A076502-003 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2006-04-11 A076502-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2011-04-12 A076502-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2011-04-12 A076502-006 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2011-04-12 A076502-007 FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2011-04-12 A076502-008 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2011-04-12 A076502-009 FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2011-04-12
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 10 · 369 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 2026-02-19 14:30 UTC 2026-02 A076502-001 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL AB 2006-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076502-002 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL AB 2006-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076502-003 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL AB 2006-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076502-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076502-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076502-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076502-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076502-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076502-009 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2011-04-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076502-001 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL AB 2006-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076502-002 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL AB 2006-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076502-003 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL AB 2006-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076502-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076502-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076502-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076502-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076502-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076502-009 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2011-04-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076502-001 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL AB 2006-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076502-002 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL AB 2006-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076502-003 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL AB 2006-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076502-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076502-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076502-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076502-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076502-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076502-009 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2011-04-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076502-001 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL AB 2006-04-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076502-002 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL AB 2006-04-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076502-003 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL AB 2006-04-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076502-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076502-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076502-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076502-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076502-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076502-009 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2011-04-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076502-001 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL AB 2006-04-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076502-002 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL AB 2006-04-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076502-003 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL AB 2006-04-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076502-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-04-12 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 120 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FEXOFENADINE HYDROCHLORIDE ACTIVE INGREDIENT 2S068B75ZU FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 3 FEXOFENADINE ACTIVE MOIETY E6582LOH6V FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 3 FERRIC OXIDE BLACK INACTIVE INGREDIENT XM0M87F357 FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 3 HYPROMELLOSE 2910 (6 CPS) INACTIVE INGREDIENT 0WZ8WG20P6 FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 3 MANNITOL INACTIVE INGREDIENT 3OWL53L36A FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 3 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 3 POWDERED CELLULOSE INACTIVE INGREDIENT SMD1X3XO9M FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 3
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 · 18 matching rows.