Home NDC 55289-728 Loratadine Allergy Relief
Product NDC 55289-728
11-digit product format 552890728
Labeler code 55289
Product ID 55289-728_4d61c38c-3562-15bd-e063-6294a90a7ada
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA076134
Marketing category ANDA
Marketing start 2017-11-01
Substance LORATADINE
Active strength 10 mg/1
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 A076134-001 LORATADINE LORATADINE 10MG TABLET / ORAL 2003-08-18
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 liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. 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 (1-800-222-1222).
Additional Listing Data#
Finished product Yes
Brand name base Loratadine Allergy Relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LORATADINE 10 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 7AJO3BO7QN Rxcui 311372
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55289-728-15 Loratadine Allergy Relief 15 in 1 BOTTLE, PLASTIC TABLET 15 19 55289-728-20 Loratadine Allergy Relief 20 in 1 BOTTLE, PLASTIC TABLET 20 19 55289-728-60 Loratadine Allergy Relief 60 in 1 BOTTLE, PLASTIC TABLET 60 19 55289-728-90 Loratadine Allergy Relief 90 in 1 BOTTLE, PLASTIC TABLET 90 19
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55289-728 LORATADINE ALLERGY RELIEF (LORATADINE) TABLET [PD-RX PHARMACEUTICALS, INC.] 16 Current NDC, Legacy NDC, 4 package rows 20240314_7127b39d-3686-4249-b720-43c02b4c4654.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 55289-728-10 55289072810 10 TABLET in 1 BOTTLE, PLASTIC (55289-728-10) 10 tablet 2020-09-30 0000-00-00 No No Current 55289-728-15 55289072815 15 TABLET in 1 BOTTLE, PLASTIC (55289-728-15) 15 tablet 2021-03-27 0000-00-00 No No Current 55289-728-20 55289072820 20 TABLET in 1 BOTTLE, PLASTIC (55289-728-20) 20 tablet 2021-03-27 0000-00-00 No No Current 55289-728-30 55289072830 30 TABLET in 1 BOTTLE, PLASTIC (55289-728-30) 30 tablet 2018-04-06 0000-00-00 No No Current 55289-728-60 55289072860 60 TABLET in 1 BOTTLE, PLASTIC (55289-728-60) 60 tablet 2023-01-18 No No Current 55289-728-90 55289072890 90 TABLET in 1 BOTTLE, PLASTIC (55289-728-90) 90 tablet 2018-04-06 0000-00-00 No No Current