Home NDC 66267-653 Loratadine
Product NDC 66267-653
11-digit product format 662670653
Labeler code 66267
Product ID 66267-653_2b4e1a74-38aa-956a-e063-6294a90ae2f1
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA076301
Marketing category ANDA
Marketing start 2008-10-15
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 A076301-001 LORATADINE LORATADINE 10MG TABLET / ORAL 2004-06-25
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
Brand name suffix antihistamine
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
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 66267-653-07 2025-01-09 C162847 48780-1 f386c649-ce89-0266-e053-dadaa90a7c1a Perrigo Loratadine Tablets, 10 mg Drug Facts 66267-653-10 2025-01-09 C162847 48780-1 f386c649-ce89-0266-e053-dadaa90a7c1a Perrigo Loratadine Tablets, 10 mg Drug Facts 66267-653-14 2025-01-09 C162847 48780-1 f386c649-ce89-0266-e053-dadaa90a7c1a Perrigo Loratadine Tablets, 10 mg Drug Facts 66267-653-20 2025-01-09 C162847 48780-1 f386c649-ce89-0266-e053-dadaa90a7c1a Perrigo Loratadine Tablets, 10 mg Drug Facts 66267-653-30 2025-01-09 C162847 48780-1 f386c649-ce89-0266-e053-dadaa90a7c1a Perrigo Loratadine Tablets, 10 mg Drug Facts 66267-653-60 2025-01-09 C162847 48780-1 f386c649-ce89-0266-e053-dadaa90a7c1a Perrigo Loratadine Tablets, 10 mg Drug Facts 66267-653-90 2025-01-09 C162847 48780-1 f386c649-ce89-0266-e053-dadaa90a7c1a Perrigo Loratadine Tablets, 10 mg Drug Facts 66267-653-07 2023-01-30 C162847 48780-1 f386c649-ce89-0266-e053-dadaa90a7c1a Perrigo Loratadine Tablets, 10 mg Drug Facts 66267-653-10 2023-01-30 C162847 48780-1 f386c649-ce89-0266-e053-dadaa90a7c1a Perrigo Loratadine Tablets, 10 mg Drug Facts 66267-653-14 2023-01-30 C162847 48780-1 f386c649-ce89-0266-e053-dadaa90a7c1a Perrigo Loratadine Tablets, 10 mg Drug Facts 66267-653-20 2023-01-30 C162847 48780-1 f386c649-ce89-0266-e053-dadaa90a7c1a Perrigo Loratadine Tablets, 10 mg Drug Facts 66267-653-30 2023-01-30 C162847 48780-1 f386c649-ce89-0266-e053-dadaa90a7c1a Perrigo Loratadine Tablets, 10 mg Drug Facts 66267-653-60 2023-01-30 C162847 48780-1 f386c649-ce89-0266-e053-dadaa90a7c1a Perrigo Loratadine Tablets, 10 mg Drug Facts 66267-653-90 2023-01-30 C162847 48780-1 f386c649-ce89-0266-e053-dadaa90a7c1a Perrigo Loratadine Tablets, 10 mg Drug Facts
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66267-653-07 Loratadineantihistamine 7 in 1 BOTTLE TABLET 7 6 66267-653-10 Loratadineantihistamine 10 in 1 BOTTLE TABLET 10 6 66267-653-14 Loratadineantihistamine 14 in 1 BOTTLE TABLET 14 6 66267-653-20 Loratadineantihistamine 20 in 1 BOTTLE TABLET 20 6 66267-653-30 Loratadineantihistamine 30 in 1 BOTTLE TABLET 30 6 66267-653-60 Loratadineantihistamine 60 in 1 BOTTLE TABLET 60 6 66267-653-90 Loratadineantihistamine 90 in 1 BOTTLE TABLET 90 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66267-653 LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [NUCARE PHARMACEUTICALS,INC.] 6 Current NDC, Legacy NDC, 7 package rows 20250112_54b37bcc-a8b0-0c17-e054-00144ff8d46c.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 66267-653-07 66267065307 7 TABLET in 1 BOTTLE (66267-653-07) 7 tablet 2017-07-19 0000-00-00 No No Current 66267-653-10 66267065310 10 TABLET in 1 BOTTLE (66267-653-10) 10 tablet 2017-07-19 0000-00-00 No No Current 66267-653-14 66267065314 14 TABLET in 1 BOTTLE (66267-653-14) 14 tablet 2017-07-19 0000-00-00 No No Current 66267-653-20 66267065320 20 TABLET in 1 BOTTLE (66267-653-20) 20 tablet 2017-07-19 0000-00-00 No No Current 66267-653-30 66267065330 30 TABLET in 1 BOTTLE (66267-653-30) 30 tablet 2017-07-19 0000-00-00 No No Current 66267-653-60 66267065360 60 TABLET in 1 BOTTLE (66267-653-60) 60 tablet 2017-07-19 0000-00-00 No No Current 66267-653-90 66267065390 90 TABLET in 1 BOTTLE (66267-653-90) 90 tablet 2017-07-19 0000-00-00 No No Current