FDA.reportPublic FDA data

Childrens Loratadine

Product NDC
51672-2131
11-digit product format
516722131
Labeler code
51672
Product ID
51672-2131_38f72eeb-30a5-812a-e063-6294a90a6890
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2131-1Childrens LoratadineSugar Free1 in 1 CARTONSOLUTION14
51672-2131-1Childrens LoratadineSugar Free240 mL in 1 BOTTLESOLUTION2404
51672-2131-4Childrens LoratadineSugar Free60 mL in 1 BOTTLESOLUTION604
51672-2131-4Childrens LoratadineSugar Free1 in 1 CARTONSOLUTION14
51672-2131-8Childrens LoratadineSugar Free120 mL in 1 BOTTLESOLUTION1204
51672-2131-8Childrens LoratadineSugar Free1 in 1 CARTONSOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2131-8ML - Milliliter51672-21313ff51a3e-245f-4e75-a21e-7fe62e546dfd12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2131CHILDRENS LORATADINE SUGAR FREE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, Legacy NDC, 6 package rows20230805_58eaab62-ac36-4080-8ded-9b472dddc617.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSN23936948-71bf-4c18-9160-22b7075e675d4
692783loratadine 5 MG in 5 mL Oral SolutionPSN58eaab62-ac36-4080-8ded-9b472dddc6174
692783loratadine 1 MG/ML Oral SolutionSCD23936948-71bf-4c18-9160-22b7075e675d4
692783loratadine 1 MG/ML Oral SolutionSCD58eaab62-ac36-4080-8ded-9b472dddc6174
692783loratadine 5 MG per 5 ML Oral SolutionSY23936948-71bf-4c18-9160-22b7075e675d4
692783loratadine 5 MG per 5 ML Oral SolutionSY58eaab62-ac36-4080-8ded-9b472dddc6174

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-2131-1516722131011 BOTTLE in 1 CARTON (51672-2131-1) / 240 mL in 1 BOTTLE1 bottle2017-03-170000-00-00NoNoCurrent
51672-2131-4516722131041 BOTTLE in 1 CARTON (51672-2131-4) / 60 mL in 1 BOTTLE1 bottle2017-03-170000-00-00NoNoCurrent
51672-2131-8516722131081 BOTTLE in 1 CARTON (51672-2131-8) / 120 mL in 1 BOTTLE1 bottle2017-03-170000-00-00NoNoCurrent