FDA.reportPublic FDA data

Loratadine

Product NDC
71335-2431
11-digit product format
713352431
Labeler code
71335
Product ID
71335-2431_0d74af21-3ef7-418b-a2ef-78737b0af288
Type
HUMAN PRESCRIPTION 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
71335-2431-1Loratadine20 in 1 BOTTLETABLET202
71335-2431-2Loratadine30 in 1 BOTTLETABLET302
71335-2431-3Loratadine60 in 1 BOTTLETABLET602
71335-2431-4Loratadine14 in 1 BOTTLETABLET142
71335-2431-5Loratadine10 in 1 BOTTLETABLET102
71335-2431-6Loratadine90 in 1 BOTTLETABLET902
71335-2431-7Loratadine28 in 1 BOTTLETABLET282
71335-2431-8Loratadine15 in 1 BOTTLETABLET152
71335-2431-9Loratadine100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2431LORATADINE TABLET [BRYANT RANCH PREPACK]1Current NDC, 9 package rows20240711_0d74af21-3ef7-418b-a2ef-78737b0af288.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN0d74af21-3ef7-418b-a2ef-78737b0af2882
311372loratadine 10 MG Oral TabletSCD0d74af21-3ef7-418b-a2ef-78737b0af2882
311372loratadine 10 MG 24 HR Oral TabletSY0d74af21-3ef7-418b-a2ef-78737b0af2882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2431-17133524310120 TABLET in 1 BOTTLE (71335-2431-1) 20 tablet2025-06-13NoNoCurrent
71335-2431-27133524310230 TABLET in 1 BOTTLE (71335-2431-2) 30 tablet2024-07-03NoNoCurrent
71335-2431-37133524310360 TABLET in 1 BOTTLE (71335-2431-3) 60 tablet2025-06-13NoNoCurrent
71335-2431-47133524310414 TABLET in 1 BOTTLE (71335-2431-4) 14 tablet2025-06-13NoNoCurrent
71335-2431-57133524310510 TABLET in 1 BOTTLE (71335-2431-5) 10 tablet2025-06-13NoNoCurrent
71335-2431-67133524310690 TABLET in 1 BOTTLE (71335-2431-6) 90 tablet2024-07-03NoNoCurrent
71335-2431-77133524310728 TABLET in 1 BOTTLE (71335-2431-7) 28 tablet2025-06-13NoNoCurrent
71335-2431-87133524310815 TABLET in 1 BOTTLE (71335-2431-8) 15 tablet2025-06-13NoNoCurrent
71335-2431-971335243109100 TABLET in 1 BOTTLE (71335-2431-9) 100 tablet2025-06-13NoNoCurrent