Home NDC 73581-201 ALLERGY RELIEF
Product NDC 73581-201
11-digit product format 735810201
Labeler code 73581
Product ID 73581-201_450fca8a-7ac1-d5fc-e063-6394a90aec36
Type HUMAN OTC DRUG
Nonproprietary name LEVOCETIRIZINE DIHYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler YYBA CORP
Application ANDA213513
Marketing category ANDA
Marketing start 2020-06-30
Substance LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength 5 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 NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded package package 73581-201 73581-201-10 D Discontinued by firm 2026-07-31
Orange Book products# Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29
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 kidney disease if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine Ask a doctor before use if you have ever had trouble urinating or emptying your bladder When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if you have trouble urinating or emptying your bladder an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use
Additional Listing Data#
Finished product Yes
Brand name base ALLERGY RELIEF
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii SOD6A38AGA Rxcui 855172
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73581-201 ALLERGY RELIEF (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET [YYBA CORP] 4 Current NDC, Legacy NDC, 6 package rows 20241004_8ee69332-742d-4071-95df-84bc42e170e7.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 73581-201-10 73581020110 1 in 1 BOX Historical 73581-201-18 73581020118 1 BOTTLE in 1 BOX (73581-201-18) / 18 TABLET in 1 BOTTLE 1 bottle 2025-12-02 No No Current 73581-201-80 73581020180 1 BOTTLE in 1 BOX (73581-201-80) / 180 TABLET in 1 BOTTLE 1 bottle 2020-06-30 0000-00-00 No No Current