Home NDC 63629-7772 Loratadine Allergy Relief
Product NDC 63629-7772
11-digit product format 636297772
Labeler code 63629
Product ID 63629-7772_8938739d-6c7a-4e91-b901-420561662ca8
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA076134
Marketing category ANDA
Marketing start 2017-11-01
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.
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 Allergy Relief
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-7772-1 Loratadine Allergy Relief 20 in 1 BOTTLE TABLET 20 6 63629-7772-2 Loratadine Allergy Relief 30 in 1 BOTTLE TABLET 30 6 63629-7772-3 Loratadine Allergy Relief 60 in 1 BOTTLE TABLET 60 6 63629-7772-4 Loratadine Allergy Relief 14 in 1 BOTTLE TABLET 14 6 63629-7772-5 Loratadine Allergy Relief 10 in 1 BOTTLE TABLET 10 6 63629-7772-6 Loratadine Allergy Relief 90 in 1 BOTTLE TABLET 90 6 63629-7772-7 Loratadine Allergy Relief 28 in 1 BOTTLE TABLET 28 6 63629-7772-8 Loratadine Allergy Relief 15 in 1 BOTTLE TABLET 15 6 63629-7772-9 Loratadine Allergy Relief 100 in 1 BOTTLE TABLET 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-7772 LORATADINE ALLERGY RELIEF (LORATADINE) TABLET [BRYANT RANCH PREPACK] 6 Current NDC, Legacy NDC, 9 package rows 20240516_94642b79-f91a-429f-87f4-dad326d4f3ed.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 63629-7772-1 63629777201 20 TABLET in 1 BOTTLE (63629-7772-1) 20 tablet 2018-07-30 0000-00-00 No No Current 63629-7772-2 63629777202 30 TABLET in 1 BOTTLE (63629-7772-2) 30 tablet 2018-07-02 0000-00-00 No No Current 63629-7772-3 63629777203 60 TABLET in 1 BOTTLE (63629-7772-3) 60 tablet 2019-11-22 0000-00-00 No No Current 63629-7772-4 63629777204 14 TABLET in 1 BOTTLE (63629-7772-4) 14 tablet 2018-12-11 0000-00-00 No No Current 63629-7772-5 63629777205 10 TABLET in 1 BOTTLE (63629-7772-5) 10 tablet 2018-07-05 0000-00-00 No No Current 63629-7772-6 63629777206 90 TABLET in 1 BOTTLE (63629-7772-6) 90 tablet 2018-07-05 0000-00-00 No No Current 63629-7772-7 63629777207 28 TABLET in 1 BOTTLE (63629-7772-7) 28 tablet 2024-04-03 0000-00-00 No No Current 63629-7772-8 63629777208 15 TABLET in 1 BOTTLE (63629-7772-8) 15 tablet 2024-04-03 0000-00-00 No No Current 63629-7772-9 63629777209 100 TABLET in 1 BOTTLE (63629-7772-9) 100 tablet 2019-06-21 0000-00-00 No No Current