Childrens Loratadine

Product NDC
41520-131
11-digit product format
415200131
Labeler code
41520
Product ID
41520-131_28dbc446-66f2-7eb5-e063-6294a90a1d1a
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
American Sales Company
Application
ANDA076805
Marketing category
ANDA
Marketing start
2017-03-17
Substance
LORATADINE
Active strength
5 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Loratadine
Brand name suffix
Sugar Free
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui692783

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-131-08Childrens Loratadine Sugar Free1 in 1 CARTONSOLUTION13
41520-131-08Childrens Loratadine Sugar Free120 mL in 1 BOTTLESOLUTION1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-131CHILDRENS LORATADINE SUGAR FREE (LORATADINE) SOLUTION [AMERICAN SALES COMPANY]3Current NDC, Legacy NDC, 2 package rows20241211_6977d7e0-9d01-4f5e-8d55-98dabb719585.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSN6977d7e0-9d01-4f5e-8d55-98dabb7195853
692783loratadine 1 MG/ML Oral SolutionSCD6977d7e0-9d01-4f5e-8d55-98dabb7195853
692783loratadine 5 MG per 5 ML Oral SolutionSY6977d7e0-9d01-4f5e-8d55-98dabb7195853

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-131-08415200131081 BOTTLE in 1 CARTON (41520-131-08) / 120 mL in 1 BOTTLE1 bottle2017-07-270000-00-00NoNoCurrent