FDA.reportPublic FDA data

Loratadine

Product NDC
58602-818
11-digit product format
586020818
Labeler code
58602
Product ID
58602-818_cfa8d72c-3d1a-464c-b63a-b7b7525c1a3c
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA211900
Marketing category
ANDA
Marketing start
2023-03-24
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
Rxcui828269

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-818-05Loratadine5 in 1 CARTONCAPSULE, LIQUID FILLED52
58602-818-05Loratadine10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED102
58602-818-08Loratadine4 in 1 CARTONCAPSULE, LIQUID FILLED42
58602-818-08Loratadine10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED102
58602-818-67Loratadine2 in 1 CARTONCAPSULE, LIQUID FILLED22
58602-818-67Loratadine10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED102
58602-818-83Loratadine1 in 1 CARTONCAPSULE, LIQUID FILLED12
58602-818-83Loratadine10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED102
58602-818-84Loratadine10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED102
58602-818-84Loratadine3 in 1 CARTONCAPSULE, LIQUID FILLED32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-818LORATADINE CAPSULE, LIQUID FILLED [AUROHEALTH LLC]2Current NDC, 10 package rows20241025_a057241d-a655-4847-9d2d-d45293f45d87.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828269loratadine 10 MG 24HR Oral CapsulePSNa057241d-a655-4847-9d2d-d45293f45d872
828269loratadine 10 MG Oral CapsuleSCDa057241d-a655-4847-9d2d-d45293f45d872
828269loratadine 10 MG 24HR Oral CapsuleSYa057241d-a655-4847-9d2d-d45293f45d872

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-818-05586020818055 BLISTER PACK in 1 CARTON (58602-818-05) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK5 blister pack2023-03-24NoNoHistorical
58602-818-08586020818084 BLISTER PACK in 1 CARTON (58602-818-08) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK4 blister pack2023-03-24NoNoHistorical
58602-818-67586020818672 BLISTER PACK in 1 CARTON (58602-818-67) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2023-03-24NoNoHistorical
58602-818-83586020818831 BLISTER PACK in 1 CARTON (58602-818-83) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2023-03-24NoNoHistorical
58602-818-84586020818843 BLISTER PACK in 1 CARTON (58602-818-84) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK3 blister pack2023-03-24NoNoHistorical