Home NDC 68071-5191 Fexofenadine hydrochloride
Product NDC 68071-5191
11-digit product format 680715191
Labeler code 68071
Product ID 68071-5191_d774a86f-537d-4344-e053-2a95a90a81e7
Type HUMAN OTC DRUG
Nonproprietary name Fexofenadine hydrochloride
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA076502
Marketing category ANDA
Marketing start 2011-01-03
Marketing end 0000-00-00
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 2023-12-31
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68071-5191-3 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68071-5191-3 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68071-5191-3 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68071-5191-3 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68071-5191-3 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68071-5191-3 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68071-5191-3 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68071-5191-3 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68071-5191-3 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68071-5191-3 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68071-5191-3 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68071-5191-3 557ba5c1ecfa…9c80585c8c6e…
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.
FDA-Initiated Inactive NDC Indexing# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68071-5191-3 68071519103 30 TABLET in 1 BOTTLE (68071-5191-3) 30 tablet 2020-03-04 0000-00-00 No No Current