Home NDC 0363-0425-53 Wal fex Allergy
Product NDC 0363-0425
Requested package NDC 0363-0425-53
11-digit product format 003630425
Labeler code 0363
Product ID 0363-0425_d5af9385-e977-4f2d-9d05-3e1876ae0744
Type HUMAN OTC DRUG
Nonproprietary name Fexofenadine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Walgreen Company
Application ANDA076447
Marketing category ANDA
Marketing start 2011-08-22
Marketing end 0000-00-00
Substance FEXOFENADINE HYDROCHLORIDE
Active strength 60 mg/1
NDC exclude flag No
Listing certified through 2022-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 8 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076447-001 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2005-09-01 A076447-002 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2005-09-01 A076447-003 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2005-09-01 A076447-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2011-04-13 A076447-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2011-04-13 A076447-006 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2011-04-13 A076447-007 FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2011-04-13 A076447-008 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2011-04-13
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 9 · 328 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 A076447-001 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL AB 2005-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076447-002 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL AB 2005-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076447-003 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL AB 2005-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076447-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-04-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076447-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-04-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076447-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-04-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076447-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-04-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076447-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-04-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076447-001 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL AB 2005-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076447-002 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL AB 2005-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076447-003 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL AB 2005-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076447-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-04-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076447-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-04-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076447-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-04-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076447-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-04-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076447-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-04-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076447-001 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL AB 2005-09-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076447-002 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL AB 2005-09-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076447-003 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL AB 2005-09-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076447-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-04-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076447-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-04-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076447-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-04-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076447-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-04-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076447-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-04-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076447-001 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL AB 2005-09-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076447-002 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL AB 2005-09-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076447-003 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL AB 2005-09-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076447-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-04-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076447-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-04-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076447-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-04-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076447-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-04-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076447-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-04-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076447-001 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL AB 2005-09-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076447-002 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL AB 2005-09-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076447-003 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL AB 2005-09-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076447-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-04-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076447-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-04-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076447-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-04-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076447-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-04-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076447-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-04-13 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 WAL FEX ALLERGY (FEXOFENADINE HCL) TABLET, FILM COATED [WALGREEN COMPANY] 1 FEXOFENADINE ACTIVE MOIETY E6582LOH6V WAL FEX ALLERGY (FEXOFENADINE HCL) TABLET, FILM COATED [WALGREEN COMPANY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U WAL FEX ALLERGY (FEXOFENADINE HCL) TABLET, FILM COATED [WALGREEN COMPANY] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 WAL FEX ALLERGY (FEXOFENADINE HCL) TABLET, FILM COATED [WALGREEN COMPANY] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 WAL FEX ALLERGY (FEXOFENADINE HCL) TABLET, FILM COATED [WALGREEN COMPANY] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT WAL FEX ALLERGY (FEXOFENADINE HCL) TABLET, FILM COATED [WALGREEN COMPANY] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 WAL FEX ALLERGY (FEXOFENADINE HCL) TABLET, FILM COATED [WALGREEN COMPANY] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO WAL FEX ALLERGY (FEXOFENADINE HCL) TABLET, FILM COATED [WALGREEN COMPANY] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X WAL FEX ALLERGY (FEXOFENADINE HCL) TABLET, FILM COATED [WALGREEN COMPANY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 WAL FEX ALLERGY (FEXOFENADINE HCL) TABLET, FILM COATED [WALGREEN COMPANY] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A WAL FEX ALLERGY (FEXOFENADINE HCL) TABLET, FILM COATED [WALGREEN COMPANY] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E WAL FEX ALLERGY (FEXOFENADINE HCL) TABLET, FILM COATED [WALGREEN COMPANY] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 WAL FEX ALLERGY (FEXOFENADINE HCL) TABLET, FILM COATED [WALGREEN COMPANY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP WAL FEX ALLERGY (FEXOFENADINE HCL) TABLET, FILM COATED [WALGREEN COMPANY] 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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0363-0425-53 00363042553 2 BLISTER PACK in 1 CARTON (0363-0425-53) > 6 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2011-08-22 0000-00-00 No No Current