Home NDC 70000-0125 Loratadine
Product NDC 70000-0125
11-digit product format 700000125
Labeler code 70000
Product ID 70000-0125_88e1fe57-4ad1-4646-b639-e935285aec4b
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form SOLUTION
Route ORAL
Labeler Cardinal Health, 110 dba LEADER
Application ANDA076805
Marketing category ANDA
Marketing start 2004-08-20
Substance LORATADINE
Active strength 5 mg/5mL
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 A076805-001 LORATADINE LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20
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 Cardinal Health, 110 dba LEADER db9d2182-6bf1-424a-a144-f2694c47989f 2021-06-23 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 5 mg/5mL
Harmonized Identifiers# Field, Values table Field Values Unii 7AJO3BO7QN Rxcui 692783
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70000-0125-1 Loratadine 118 mL in 1 BOTTLE SOLUTION 118 3 70000-0125-1 Loratadine 1 in 1 CARTON SOLUTION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0125 LORATADINE SOLUTION [CARDINAL HEALTH, 110 DBA LEADER] 3 Current NDC, Legacy NDC, 2 package rows 20210626_db9d2182-6bf1-424a-a144-f2694c47989f.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 70000-0125-1 70000012501 1 BOTTLE in 1 CARTON (70000-0125-1) / 118 mL in 1 BOTTLE 1 bottle 2016-10-24 0000-00-00 No No Current