Loratadine Allergy Relief

Product NDC
50090-7508
11-digit product format
500907508
Labeler code
50090
Product ID
50090-7508_49bbeae9-aed2-4189-a3a7-e1598667beb8
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
50090-7508-4Loratadine Allergy Relief90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7508-4EA - Each50090-75085217fa26-ffad-4bdb-bf9c-88f0d07abf7012025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7508LORATADINE ALLERGY RELIEF (LORATADINE) TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20250223_0be70365-57ee-4f2e-a30f-bdd5c292992d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN0be70365-57ee-4f2e-a30f-bdd5c292992d1
311372loratadine 10 MG Oral TabletSCD0be70365-57ee-4f2e-a30f-bdd5c292992d1
311372loratadine 10 MG 24 HR Oral TabletSY0be70365-57ee-4f2e-a30f-bdd5c292992d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7508-45009075080490 TABLET in 1 BOTTLE (50090-7508-4) 90 tablet2025-02-18NoNoHistorical