Home NDC 51079-547 Fexofenadine Hydrochloride
Product NDC 51079-547
11-digit product format 510790547
Labeler code 51079
Product ID 51079-547_d1f32dc7-8a7d-e0a5-e053-2995a90a8963
Type HUMAN OTC DRUG
Nonproprietary name fexofenadine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Institutional Inc.
Application ANDA077081
Marketing category ANDA
Marketing start 2012-02-13
Marketing end 2022-02-28
Substance FEXOFENADINE HYDROCHLORIDE
Active strength 60 mg/1
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 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.
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 2026-08-01 22:54:32 2026-06 A077081-001 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2007-04-16 a50c72e98297…2026-08-01 22:54:32 2026-06 A077081-002 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2008-04-11 a50c72e98297…2026-08-01 22:54:32 2026-06 A077081-003 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2008-04-11 a50c72e98297…2026-08-01 22:54:32 2026-06 A077081-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-07-21 a50c72e98297…2026-08-01 22:54:32 2026-06 A077081-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-07-21 a50c72e98297…2026-08-01 22:54:32 2026-06 A077081-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-07-21 a50c72e98297…2026-08-01 22:54:32 2026-06 A077081-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-07-21 a50c72e98297…2026-08-01 22:54:32 2026-06 A077081-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-07-21 a50c72e98297…2026-08-01 22:54:32 2026-06 A077081-009 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2011-07-21 a50c72e98297…
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51079-547-20 51079054720 100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-547-20) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-547-01) 100 blister pack 2012-02-13 0000-00-00 No No Current