Childrens Loratadine

Product NDC
51672-2108
11-digit product format
516722108
Labeler code
51672
Product ID
51672-2108_31f7a7ea-9574-4641-a4ab-55f2c1f1d3e4
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
ANDA201865
Marketing category
ANDA
Marketing start
2016-12-08
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
51672-2108-1Childrens Loratadine Sugar Free1 in 1 CARTONSOLUTION15
51672-2108-1Childrens Loratadine Sugar Free240 mL in 1 BOTTLESOLUTION2405
51672-2108-8Childrens Loratadine Sugar Free1 in 1 CARTONSOLUTION15
51672-2108-8Childrens Loratadine Sugar Free120 mL in 1 BOTTLESOLUTION1205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2108CHILDRENS LORATADINE SUGAR FREE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 4 package rows20210418_96a76906-58ad-40cd-be27-4ea254e298c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSN96a76906-58ad-40cd-be27-4ea254e298c55
692783loratadine 1 MG/ML Oral SolutionSCD96a76906-58ad-40cd-be27-4ea254e298c55
692783loratadine 5 MG per 5 ML Oral SolutionSY96a76906-58ad-40cd-be27-4ea254e298c55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-2108-1516722108011 BOTTLE in 1 CARTON (51672-2108-1) / 240 mL in 1 BOTTLE1 bottle2016-12-080000-00-00NoNoCurrent
51672-2108-8516722108081 BOTTLE in 1 CARTON (51672-2108-8) / 120 mL in 1 BOTTLE1 bottle2016-12-080000-00-00NoNoCurrent