FDA.reportPublic FDA data

Loratadine

Product NDC
71335-2529
11-digit product format
713352529
Labeler code
71335
Product ID
71335-2529_a5d54183-06a9-4ae1-93b9-e9a2e03ad42b
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210722
Marketing category
ANDA
Marketing start
2020-01-01
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Loratadine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui311372

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2529-1Loratadine20 in 1 BOTTLETABLET202
71335-2529-2Loratadine30 in 1 BOTTLETABLET302
71335-2529-3Loratadine60 in 1 BOTTLETABLET602
71335-2529-4Loratadine14 in 1 BOTTLETABLET142
71335-2529-5Loratadine10 in 1 BOTTLETABLET102
71335-2529-6Loratadine90 in 1 BOTTLETABLET902
71335-2529-7Loratadine28 in 1 BOTTLETABLET282
71335-2529-8Loratadine15 in 1 BOTTLETABLET152
71335-2529-9Loratadine100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2529LORATADINE TABLET [BRYANT RANCH PREPACK]1Current NDC, 9 package rows20241127_a5d54183-06a9-4ae1-93b9-e9a2e03ad42b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNa5d54183-06a9-4ae1-93b9-e9a2e03ad42b2
311372loratadine 10 MG Oral TabletSCDa5d54183-06a9-4ae1-93b9-e9a2e03ad42b2
311372loratadine 10 MG 24 HR Oral TabletSYa5d54183-06a9-4ae1-93b9-e9a2e03ad42b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2529-17133525290120 TABLET in 1 BOTTLE (71335-2529-1) 20 tablet2025-02-10NoNoHistorical
71335-2529-27133525290230 TABLET in 1 BOTTLE (71335-2529-2) 30 tablet2024-11-22NoNoHistorical
71335-2529-37133525290360 TABLET in 1 BOTTLE (71335-2529-3) 60 tablet2025-06-13NoNoHistorical
71335-2529-47133525290414 TABLET in 1 BOTTLE (71335-2529-4) 14 tablet2025-06-13NoNoHistorical
71335-2529-57133525290510 TABLET in 1 BOTTLE (71335-2529-5) 10 tablet2025-06-13NoNoHistorical
71335-2529-67133525290690 TABLET in 1 BOTTLE (71335-2529-6) 90 tablet2024-12-16NoNoHistorical
71335-2529-77133525290728 TABLET in 1 BOTTLE (71335-2529-7) 28 tablet2025-06-13NoNoHistorical
71335-2529-87133525290815 TABLET in 1 BOTTLE (71335-2529-8) 15 tablet2025-06-13NoNoHistorical
71335-2529-971335252909100 TABLET in 1 BOTTLE (71335-2529-9) 100 tablet2025-06-13NoNoHistorical