Home NDC 10544-231 Fexofenadine Hydrochloride
Product NDC 10544-231
11-digit product format 105440231
Labeler code 10544
Product ID 10544-231_11926194-a657-2bfb-e054-00144ff88e88
Type HUMAN OTC DRUG
Nonproprietary name Fexofenadine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Blenheim Pharmacal, Inc.
Application ANDA076447
Marketing category ANDA
Marketing start 2013-11-13
Marketing end 0000-00-00
Substance FEXOFENADINE HYDROCHLORIDE
Active strength 60 mg/1
NDC exclude flag E
Listing certified through 2017-12-31
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 · 44 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 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 10544-231-30 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 10544-231-30 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 10544-231-30 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 10544-231-30 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 10544-231-30 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 10544-231-30 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 10544-231-30 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 10544-231-30 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 10544-231-30 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 10544-231-30 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 10544-231-30 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 10544-231-30 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 10544-231-30 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 10544-231-30 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 10544-231-30 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 10544-231-30 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 10544-231-30 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 10544-231-30 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 10544-231-30 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 10544-231-30 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 10544-231-30 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…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 10544-231-30 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 · 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 Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10544-231-30 Fexofenadine Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FEXOFENADINE HYDROCHLORIDE ACTIVE INGREDIENT 2S068B75ZU FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 FEXOFENADINE ACTIVE MOIETY E6582LOH6V FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10544-231 FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 Legacy NDC, 1 package rows 20150318_11926194-a656-2bfb-e054-00144ff88e88.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 10544-231-30 10544023130 30 in 1 BOTTLE Historical