Home NDC 63868-151 Loratadine
Product NDC 63868-151
11-digit product format 638680151
Labeler code 63868
Product ID 63868-151_08f2bf78-eba5-41ce-bcb0-733e2760d44b
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form TABLET
Route ORAL
Labeler Chain Drug Marketing Association Inc.
Application ANDA076134
Marketing category ANDA
Marketing start 2003-08-19
Substance LORATADINE
Active strength 10 mg/1
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 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Loratadine LORATADINE Chain Drug Marketing Association Inc. b4edf5b1-398d-405a-8a42-76044b31ebb7 2018-08-27 Warnings Exact identifier
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
Listing expiration 2026-12-31 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 63868-151-01 Loratadine 100 in 1 BOTTLE TABLET 100 2 63868-151-10 Loratadine 10 in 1 BLISTER PACK TABLET 10 2 63868-151-30 Loratadine 30 in 1 BLISTER PACK TABLET 30 2
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-151 LORATADINE TABLET [CHAIN DRUG MARKETING ASSOCIATION INC.] 2 Current NDC, Legacy NDC, 3 package rows 20180829_b4edf5b1-398d-405a-8a42-76044b31ebb7.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 63868-151-01 63868015101 100 TABLET in 1 BOTTLE (63868-151-01) 100 tablet 2003-08-19 0000-00-00 No No Current 63868-151-10 63868015110 10 TABLET in 1 BLISTER PACK (63868-151-10) 10 tablet 2003-08-19 0000-00-00 No No Current 63868-151-30 63868015130 30 TABLET in 1 BLISTER PACK (63868-151-30) 30 tablet 2003-08-19 0000-00-00 No No Current