Home NDC 0378-0782-93 Fexofenadine Hydrochloride
Product NDC 0378-0782
Requested package NDC 0378-0782-93
11-digit product format 003780782
Labeler code 0378
Product ID 0378-0782_f35905cb-7f58-41f1-a851-403032789d14
Type HUMAN OTC DRUG
Nonproprietary name fexofenadine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA077081
Marketing category ANDA
Marketing start 2011-08-25
Marketing end 2022-02-28
Substance FEXOFENADINE HYDROCHLORIDE
Active strength 180 mg/1
NDC exclude flag No
Listing certified through 0000-00-00
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 43 .
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 A077081-001 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2007-04-16 A077081-002 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2008-04-11 A077081-003 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2008-04-11 A077081-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2011-07-21 A077081-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2011-07-21 A077081-006 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2011-07-21 A077081-007 FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2011-07-21 A077081-008 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2011-07-21 A077081-009 FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2011-07-21
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 · 387 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 A077081-001 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2007-04-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077081-002 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2008-04-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077081-003 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2008-04-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077081-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-07-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077081-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-07-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077081-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-07-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077081-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-07-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077081-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-07-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077081-009 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2011-07-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077081-001 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2007-04-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077081-002 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2008-04-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077081-003 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2008-04-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077081-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-07-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077081-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-07-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077081-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-07-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077081-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-07-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077081-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-07-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077081-009 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2011-07-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077081-001 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL AB 2007-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077081-002 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2008-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077081-003 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL AB 2008-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077081-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-07-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077081-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-07-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077081-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-07-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077081-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-07-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077081-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-07-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077081-009 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2011-07-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077081-001 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL AB 2007-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077081-002 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2008-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077081-003 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL AB 2008-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077081-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-07-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077081-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-07-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077081-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-07-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077081-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-07-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077081-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-07-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077081-009 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2011-07-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077081-001 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL AB 2007-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077081-002 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2008-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077081-003 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL AB 2008-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077081-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-07-21 6a471c1ec25d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 81 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 [MYLAN INSTITUTIONAL INC.] 4 FEXOFENADINE ACTIVE MOIETY E6582LOH6V FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 4 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 4 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 4 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 4 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 4 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 4 POVIDONES INACTIVE INGREDIENT FZ989GH94E FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 4 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 4 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 4 FEXOFENADINE HYDROCHLORIDE ACTIVE INGREDIENT 2S068B75ZU FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 2 FEXOFENADINE ACTIVE MOIETY E6582LOH6V FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 2 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 2 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 2 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0378-0782-93 00378078293 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0782-93) 2011-08-25 2022-02-28 No No Current