Home NDC 43353-760 Fexofenadine Hydrochloride
Product NDC 43353-760
11-digit product format 433530760
Labeler code 43353
Product ID 43353-760_3b6da186-33ef-4a85-90df-f008a31ab498
Type HUMAN OTC DRUG
Nonproprietary name fexofenadine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA077081
Marketing category ANDA
Marketing start 2014-03-20
Marketing end 0000-00-00
Substance FEXOFENADINE HYDROCHLORIDE
Active strength 180 mg/1
NDC exclude flag E
Listing certified through 2018-12-31
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 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 396 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 2026-10-15 13:18:30 2026-09 A077081-001 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2007-04-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077081-002 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2008-04-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077081-003 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2008-04-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077081-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-07-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077081-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-07-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077081-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-07-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077081-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-07-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077081-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-07-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077081-009 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2011-07-21 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 3 of 3 · 81 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077081-003 AB 1 cb3db0bc1861…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43353-760-53 Fexofenadine Hydrochloride 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 1 43353-760-60 Fexofenadine Hydrochloride 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-760 FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Legacy NDC, 2 package rows 20171205_d0a79081-71e0-407d-876b-f4393fd4d1e5.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 43353-760-53 43353076053 30 in 1 BOTTLE, PLASTIC Historical 43353-760-60 43353076060 90 in 1 BOTTLE, PLASTIC Historical