Home NDC 55315-528 Loratadine
Product NDC 55315-528
11-digit product format 553150528
Labeler code 55315
Product ID 55315-528_30c112e9-7c17-45cc-829d-d0cceea230c4
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form TABLET
Route ORAL
Labeler Fred's Inc.
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 2020-12-31
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 55315-528 I Inactivated by FDA 2026-07-31 excluded package package 55315-528 55315-528-31 I Inactivated by FDA 2026-07-31 excluded package package 55315-528 55315-528-69 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 55315-528-31 Loratadine 30 in 1 BLISTER PACK TABLET 30 2 55315-528-69 Loratadine 10 in 1 BLISTER PACK TABLET 10 2
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55315-528 LORATADINE TABLET [FRED'S INC.] 2 Legacy NDC, 2 package rows 20191219_3c7870d7-0f76-49be-bca4-459443ba9467.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 55315-528-31 55315052831 30 TABLET in 1 BLISTER PACK (55315-528-31) 30 tablet 2003-08-19 0000-00-00 No No Current 55315-528-69 55315052869 10 TABLET in 1 BLISTER PACK (55315-528-69) 10 tablet 2003-08-19 0000-00-00 No No Current