Home NDC 36800-571 topcare fexofenadine hydrochloride
Product NDC 36800-571
11-digit product format 368000571
Labeler code 36800
Product ID 36800-571_a16be9a0-cfd2-4d51-8064-64db78d2cc4c
Type HUMAN OTC DRUG
Nonproprietary name fexofenadine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Topco Associates LLC
Application ANDA076447
Marketing category ANDA
Marketing start 2011-04-14
Marketing end 2021-02-28
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 2 · 108 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 336 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 2026-08-18 06:07:40 2026-07 A076447-001 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2005-09-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076447-002 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2005-09-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076447-003 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2005-09-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076447-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-04-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076447-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-04-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076447-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-04-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076447-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-04-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076447-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-04-13 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 120 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FEXOFENADINE HYDROCHLORIDE ACTIVE INGREDIENT 2S068B75ZU TOPCARE FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 FEXOFENADINE ACTIVE MOIETY E6582LOH6V TOPCARE FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TOPCARE FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 TOPCARE FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 TOPCARE FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TOPCARE FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 TOPCARE FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TOPCARE FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TOPCARE FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TOPCARE FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TOPCARE FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E TOPCARE FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TOPCARE FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TOPCARE FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-571-39 36800057139 1 BOTTLE in 1 CARTON (36800-571-39) > 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2011-04-14 2021-02-28 No No Current 36800-571-75 36800057175 1 BOTTLE in 1 CARTON (36800-571-75) > 90 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2011-10-19 2021-02-28 No No Current 36800-571-95 36800057195 1 BOTTLE in 1 CARTON (36800-571-95) > 45 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2011-09-09 2021-02-28 No No Current