Home NDC 62207-765 Fexofenadine Hydrochloride
Product NDC 62207-765
11-digit product format 622070765
Labeler code 62207
Product ID 62207-765_3b98f58b-cf16-dcd8-e063-6394a90a8b01
Type HUMAN OTC DRUG
Nonproprietary name Fexofenadine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Granules India Ltd
Application ANDA211075
Marketing category ANDA
Marketing start 2020-12-18
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 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 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 997420, 997501
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62207-765-49 Fexofenadine Hydrochloride 1000 in 1 BOTTLE TABLET 1000 7 62207-765-51 Fexofenadine Hydrochloride 1 in 1 CARTON TABLET 1 7 62207-765-51 Fexofenadine Hydrochloride 10 in 1 BOTTLE TABLET 10 7 62207-765-60 Fexofenadine Hydrochloride 8 in 1 CARTON TABLET 8 7 62207-765-60 Fexofenadine Hydrochloride 9 in 1 BLISTER PACK TABLET 9 7 62207-765-88 Fexofenadine Hydrochloride 5 in 1 BOX TABLET 5 7 62207-765-88 Fexofenadine Hydrochloride 10000 in 1 POUCH TABLET 10000 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62207-765 FEXOFENADINE HYDROCHLORIDE TABLET [GRANULES INDIA LTD] 6 Current NDC, Legacy NDC, 7 package rows 20230131_3151bc6d-b40b-4200-a5cf-e57b6791d92a.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 62207-765-49 62207076549 1000 TABLET in 1 BOTTLE (62207-765-49) 1000 tablet 2020-12-18 0000-00-00 No No Current 62207-765-51 62207076551 1 BOTTLE in 1 CARTON (62207-765-51) / 10 TABLET in 1 BOTTLE 1 bottle 2020-12-18 0000-00-00 No No Current 62207-765-60 62207076560 8 BLISTER PACK in 1 CARTON (62207-765-60) / 9 TABLET in 1 BLISTER PACK 8 blister pack 2020-12-18 0000-00-00 No No Current 62207-765-88 62207076588 5 POUCH in 1 BOX (62207-765-88) / 10000 TABLET in 1 POUCH 5 pouch 2021-11-17 0000-00-00 No No Current