Loratadine 10mg

Product NDC
69168-475
11-digit product format
691680475
Labeler code
69168
Product ID
69168-475_1307fce8-d753-4df5-90f0-a902befdfe35
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine 10mg
Dosage form
TABLET
Route
ORAL
Labeler
Allegiant Health
Application
ANDA211718
Marketing category
ANDA
Marketing start
2025-03-18
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 10mg
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
69168-475-02Loratadine 10mg150 in 1 BOTTLETABLET15010
69168-475-05Loratadine 10mg500 in 1 BOTTLETABLET50010
69168-475-08Loratadine 10mg1 in 1 CARTONTABLET110
69168-475-08Loratadine 10mg5 in 1 BLISTER PACKTABLET510
69168-475-09Loratadine 10mg10 in 1 BLISTER PACKTABLET1010
69168-475-09Loratadine 10mg1 in 1 CARTONTABLET110
69168-475-17Loratadine 10mg300 in 1 BOTTLETABLET30010
69168-475-30Loratadine 10mg1 in 1 CARTONTABLET110
69168-475-30Loratadine 10mg30 in 1 BOTTLETABLET3010
69168-475-60Loratadine 10mg60 in 1 BOTTLETABLET6010
69168-475-99Loratadine 10mg365 in 1 BOTTLETABLET36510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-475ALLERGY RELIEF (LORATADINE) TABLET LORATADINE 10MG TABLET [ALLEGIANT HEALTH]8Current NDC, 11 package rows20250321_f0db3a13-43e6-4243-9a3a-7808ddd005e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNf0db3a13-43e6-4243-9a3a-7808ddd005e110
311372loratadine 10 MG Oral TabletSCDf0db3a13-43e6-4243-9a3a-7808ddd005e110
311372loratadine 10 MG 24 HR Oral TabletSYf0db3a13-43e6-4243-9a3a-7808ddd005e110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69168-475-0269168047502150 TABLET in 1 BOTTLE (69168-475-02) 150 tablet2025-03-18NoNoHistorical
69168-475-0569168047505500 TABLET in 1 BOTTLE (69168-475-05) 500 tablet2025-11-11NoNoHistorical
69168-475-08691680475081 BLISTER PACK in 1 CARTON (69168-475-08) / 5 TABLET in 1 BLISTER PACK1 blister pack2025-09-30NoNoHistorical
69168-475-09691680475091 BLISTER PACK in 1 CARTON (69168-475-09) / 10 TABLET in 1 BLISTER PACK1 blister pack2025-09-30NoNoHistorical
69168-475-1769168047517300 TABLET in 1 BOTTLE (69168-475-17) 300 tablet2025-09-30NoNoHistorical
69168-475-30691680475301 BOTTLE in 1 CARTON (69168-475-30) / 30 TABLET in 1 BOTTLE1 bottle2025-09-30NoNoHistorical
69168-475-606916804756060 TABLET in 1 BOTTLE (69168-475-60) 60 tablet2025-09-30NoNoHistorical
69168-475-9969168047599365 TABLET in 1 BOTTLE (69168-475-99) 365 tablet2025-09-30NoNoHistorical