Home NDC 71399-8659 fexofenadine hcl
Product NDC 71399-8659
11-digit product format 713998659
Labeler code 71399
Product ID 71399-8659_48c50815-5149-7bba-e063-6294a90a714d
Type HUMAN OTC DRUG
Nonproprietary name fexofenadine hcl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AKRON PHARMA INC
Application ANDA204507
Marketing category ANDA
Marketing start 2014-12-26
Substance FEXOFENADINE HYDROCHLORIDE
Active strength 60 mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FEXOFENADINE HYDROCHLORIDE 60 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 2S068B75ZU Rxcui 997501
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 71399-8659-1 fexofenadine hcl 100 in 1 BOTTLE TABLET, FILM COATED 100 4 71399-8659-5 fexofenadine hcl 500 in 1 BOTTLE TABLET, FILM COATED 500 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71399-8659 FEXOFENADINE HCL TABLET, FILM COATED [AKRON PHARMA INC] 3 Current NDC, Legacy NDC, 2 package rows 20240221_fe67f0f1-c6f1-424e-8226-19176de79945.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 71399-8659-1 71399865901 100 TABLET, FILM COATED in 1 BOTTLE (71399-8659-1) 2021-11-01 0000-00-00 No No Current 71399-8659-5 71399865905 500 TABLET, FILM COATED in 1 BOTTLE (71399-8659-5) 2024-02-02 No No Current