Home NDC 37012-526 Loratadine
Product NDC 37012-526
11-digit product format 370120526
Labeler code 37012
Product ID 37012-526_21c4e5cc-a1e7-467c-ab88-a2cde5b56c68
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form TABLET
Route ORAL
Labeler Shopko Stores Operating Co., LLC
Application ANDA076134
Marketing category ANDA
Marketing start 2003-08-19
Marketing end 0000-00-00
Substance LORATADINE
Active strength 10 mg/1
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record 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 product product 37012-526 I Inactivated by FDA 2026-07-31 excluded package package 37012-526 37012-526-31 I Inactivated by FDA 2026-07-31 excluded package package 37012-526 37012-526-60 I Inactivated by FDA 2026-07-31 excluded package package 37012-526 37012-526-69 I Inactivated by FDA 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 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).
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 37012-526-31 Loratadine 30 in 1 BLISTER PACK TABLET 30 1 37012-526-60 Loratadine 60 in 1 BOTTLE TABLET 60 1 37012-526-69 Loratadine 10 in 1 BLISTER PACK TABLET 10 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LORATADINE ACTIVE INGREDIENT 7AJO3BO7QN LORATADINE TABLET [SHOPKO STORES OPERATING CO., LLC] 1 LORATADINE ACTIVE MOIETY 7AJO3BO7QN LORATADINE TABLET [SHOPKO STORES OPERATING CO., LLC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LORATADINE TABLET [SHOPKO STORES OPERATING CO., LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LORATADINE TABLET [SHOPKO STORES OPERATING CO., LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LORATADINE TABLET [SHOPKO STORES OPERATING CO., LLC] 1 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ LORATADINE TABLET [SHOPKO STORES OPERATING CO., LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 37012-526 LORATADINE TABLET [SHOPKO STORES OPERATING CO., LLC] 1 Legacy NDC, 3 package rows 20130326_9d8888e6-26d6-48cb-afa1-34880dcf668e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 37012-526-31 37012052631 30 in 1 BLISTER PACK Historical 37012-526-60 37012052660 60 in 1 BOTTLE Historical 37012-526-69 37012052669 10 in 1 BLISTER PACK Historical