Home NDC 68016-119 Fexofenadine HCl
Product NDC 68016-119
11-digit product format 680160119
Labeler code 68016
Product ID 68016-119_3b3fd1c4-ca83-4ef3-9db3-785d17c315a4
Type HUMAN OTC DRUG
Nonproprietary name Fexofenadine HCl
Dosage form TABLET
Route ORAL
Labeler Chain Drug Consortium, LLC
Application ANDA079112
Marketing category ANDA
Marketing start 2012-06-18
Marketing end 0000-00-00
Substance FEXOFENADINE HYDROCHLORIDE
Active strength 180 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 · 57 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 68016-119-00 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68016-119-01 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 68016-119-00 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68016-119-01 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 68016-119-00 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68016-119-01 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 68016-119-00 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68016-119-01 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 68016-119-00 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68016-119-01 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 68016-119-00 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68016-119-01 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 68016-119-00 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68016-119-01 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 68016-119-00 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68016-119-01 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 68016-119-00 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68016-119-01 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 68016-119-00 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68016-119-01 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 68016-119-00 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68016-119-01 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 68016-119-00 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68016-119-01 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…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 68016-119-00 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 68016-119-01 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 68016-119-00 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 68016-119-01 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 68016-119-00 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 68016-119-01 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 68016-119-00 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 68016-119-01 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 68016-119-00 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 68016-119-01 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 68016-119-00 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 68016-119-01 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 68016-119-01 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 68016-119-00 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A079112-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2012-02-08 A079112-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2012-02-08 A079112-003 FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2012-02-08 A079112-004 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2012-02-08 A079112-005 FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2012-02-08 A079112-006 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2012-02-08
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 · 258 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 2026-09-14 22:38:34 2026-08 A079112-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2012-02-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079112-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2012-02-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079112-003 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2012-02-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079112-004 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2012-02-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079112-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2012-02-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079112-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2012-02-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A079112-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2012-02-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079112-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2012-02-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079112-003 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2012-02-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079112-004 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2012-02-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079112-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2012-02-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079112-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2012-02-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079112-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2012-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079112-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2012-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079112-003 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2012-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079112-004 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2012-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079112-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2012-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079112-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2012-02-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079112-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2012-02-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079112-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2012-02-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079112-003 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2012-02-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079112-004 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2012-02-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079112-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2012-02-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079112-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2012-02-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079112-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2012-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079112-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2012-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079112-003 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2012-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079112-004 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2012-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079112-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2012-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079112-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2012-02-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079112-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2012-02-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079112-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2012-02-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079112-003 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2012-02-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079112-004 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2012-02-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079112-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2012-02-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079112-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2012-02-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079112-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2012-02-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079112-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2012-02-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079112-003 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2012-02-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079112-004 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2012-02-08 b8a1b40f171c…
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FEXOFENADINE HYDROCHLORIDE ACTIVE INGREDIENT 2S068B75ZU FEXOFENADINE HCL TABLET [CHAIN DRUG CONSORTIUM, LLC] 3 FEXOFENADINE ACTIVE MOIETY E6582LOH6V FEXOFENADINE HCL TABLET [CHAIN DRUG CONSORTIUM, LLC] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FEXOFENADINE HCL TABLET [CHAIN DRUG CONSORTIUM, LLC] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FEXOFENADINE HCL TABLET [CHAIN DRUG CONSORTIUM, LLC] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 FEXOFENADINE HCL TABLET [CHAIN DRUG CONSORTIUM, LLC] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT FEXOFENADINE HCL TABLET [CHAIN DRUG CONSORTIUM, LLC] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FEXOFENADINE HCL TABLET [CHAIN DRUG CONSORTIUM, LLC] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FEXOFENADINE HCL TABLET [CHAIN DRUG CONSORTIUM, LLC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FEXOFENADINE HCL TABLET [CHAIN DRUG CONSORTIUM, LLC] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A FEXOFENADINE HCL TABLET [CHAIN DRUG CONSORTIUM, LLC] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E FEXOFENADINE HCL TABLET [CHAIN DRUG CONSORTIUM, LLC] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FEXOFENADINE HCL TABLET [CHAIN DRUG CONSORTIUM, LLC] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U FEXOFENADINE HCL TABLET [CHAIN DRUG CONSORTIUM, LLC] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FEXOFENADINE HCL TABLET [CHAIN DRUG CONSORTIUM, LLC] 3