Home NDC 71309-091 Fexofenadine Hydrochloride
Product NDC 71309-091
11-digit product format 713090091
Labeler code 71309
Product ID 71309-091_f7f18cee-5649-13c4-e053-6294a90ad4a8
Type HUMAN OTC DRUG
Nonproprietary name Fexofenadine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Safrel Pharmaceuticals, LLC.
Application ANDA211075
Marketing category ANDA
Marketing start 2021-01-03
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 A211075-001 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2019-10-18 A211075-002 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2019-10-18
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.
Additional Listing Data#
Finished product Yes
Brand name base Fexofenadine Hydrochloride
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 71309-091-01 Fexofenadine Hydrochloride 100 in 1 BOTTLE TABLET 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71309-091 FEXOFENADINE HYDROCHLORIDE TABLET [SAFREL PHARMACEUTICALS, LLC.] 2 Current NDC, Legacy NDC, 1 package rows 20230329_d6120f56-ab28-2696-e053-2995a90adf47.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71309-091-01 71309009101 100 TABLET in 1 BOTTLE (71309-091-01) 100 tablet 2021-01-31 0000-00-00 No No Current