Home NDC 71610-905 fexofenadine hcl
Product NDC 71610-905
11-digit product format 716100905
Labeler code 71610
Product ID 71610-905_34917b34-89a7-2a13-e063-6394a90a9038
Type HUMAN OTC DRUG
Nonproprietary name fexofenadine hcl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA204507
Marketing category ANDA
Marketing start 2025-03-10
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 2026-12-31
Current FDA listing Yes Orange Book products# Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204507-002 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2015-09-16 A204507-003 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2015-09-16 A204507-004 FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2015-09-16 A204507-005 FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2015-09-16
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Additional Listing Data#
Finished product Yes
Brand name base fexofenadine hcl
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FEXOFENADINE HYDROCHLORIDE 180 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 2S068B75ZU Rxcui 997420
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71610-905-30 fexofenadine hcl 30 in 1 BOTTLE TABLET, FILM COATED 30 1 71610-905-53 fexofenadine hcl 60 in 1 BOTTLE TABLET, FILM COATED 60 1 71610-905-60 fexofenadine hcl 90 in 1 BOTTLE TABLET, FILM COATED 90 1 71610-905-80 fexofenadine hcl 180 in 1 BOTTLE TABLET, FILM COATED 180 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-905 FEXOFENADINE HCL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ] 1 Current NDC, 4 package rows 20250515_34918a5a-c4c9-bc79-e063-6294a90acb85.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71610-905-30 71610090530 30 TABLET, FILM COATED in 1 BOTTLE (71610-905-30) 2025-05-07 No No Current 71610-905-53 71610090553 60 TABLET, FILM COATED in 1 BOTTLE (71610-905-53) 2025-05-07 No No Current 71610-905-60 71610090560 90 TABLET, FILM COATED in 1 BOTTLE (71610-905-60) 2025-05-07 No No Current 71610-905-80 71610090580 180 TABLET, FILM COATED in 1 BOTTLE (71610-905-80) 2025-05-07 No No Current