FDA.reportPublic FDA data

Loratadine Allergy Relief

Product NDC
50090-7507
11-digit product format
500907507
Labeler code
50090
Product ID
50090-7507_4f289ad2-8afb-45fa-822c-5154fe440271
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076134
Marketing category
ANDA
Marketing start
2022-10-01
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 Allergy Relief
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
50090-7507-0Loratadine Allergy Relief10 in 1 BOTTLETABLET101
50090-7507-4Loratadine Allergy Relief30 in 1 BOTTLETABLET301
50090-7507-5Loratadine Allergy Relief90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7507-4EA - Each50090-75072c9259c4-8eb1-4289-8789-537f12a096e512025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7507LORATADINE ALLERGY RELIEF (LORATADINE) TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20250223_baaf9c23-0b54-46a2-8aec-13264479a6d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNbaaf9c23-0b54-46a2-8aec-13264479a6d71
311372loratadine 10 MG Oral TabletSCDbaaf9c23-0b54-46a2-8aec-13264479a6d71
311372loratadine 10 MG 24 HR Oral TabletSYbaaf9c23-0b54-46a2-8aec-13264479a6d71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7507-05009075070010 TABLET in 1 BOTTLE (50090-7507-0) 10 tablet2025-02-18NoNoHistorical
50090-7507-45009075070430 TABLET in 1 BOTTLE (50090-7507-4) 30 tablet2025-02-18NoNoHistorical
50090-7507-55009075070590 TABLET in 1 BOTTLE (50090-7507-5) 90 tablet2025-02-18NoNoHistorical