FDA.reportPublic FDA data

Childrens Loratadine

Product NDC
51672-2073
11-digit product format
516722073
Labeler code
51672
Product ID
51672-2073_4ef454c5-7e60-4107-e063-6394a90a6f93
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA076805
Marketing category
ANDA
Marketing start
2004-08-20
Substance
LORATADINE
Active strength
5 mg/5mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Loratadine
Listing expiration
2027-12-31

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
51672-2073-4Childrens Loratadine60 mL in 1 BOTTLESOLUTION607
51672-2073-4Childrens Loratadine1 in 1 CARTONSOLUTION17
51672-2073-5Childrens Loratadine180 mL in 1 BOTTLESOLUTION1807
51672-2073-5Childrens Loratadine1 in 1 CARTONSOLUTION17
51672-2073-8Childrens Loratadine120 mL in 1 BOTTLESOLUTION1207
51672-2073-8Childrens Loratadine1 in 1 CARTONSOLUTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2073-8ML - Milliliter51672-20738d48a532-2118-4d9a-bd23-7f5e5e5d50d112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LoratadineACTIVE INGREDIENT7AJO3BO7QNCHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
LoratadineACTIVE MOIETY7AJO3BO7QNCHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPCHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXCHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUCHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
sodium metabisulfiteINACTIVE INGREDIENT4VON5FNS3CCHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
sucroseINACTIVE INGREDIENTC151H8M554CHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
waterINACTIVE INGREDIENT059QF0KO0RCHILDRENS LORATADINE (LORATADINE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
LoratadineACTIVE INGREDIENT7AJO3BO7QNLORATADINE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
LoratadineACTIVE INGREDIENT7AJO3BO7QNLORATADINE SOLUTION [REBEL DISTRIBUTORS CORP]1
LoratadineACTIVE MOIETY7AJO3BO7QNLORATADINE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
LoratadineACTIVE MOIETY7AJO3BO7QNLORATADINE SOLUTION [REBEL DISTRIBUTORS CORP]1
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPLORATADINE SOLUTION [REBEL DISTRIBUTORS CORP]1
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPLORATADINE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXLORATADINE SOLUTION [REBEL DISTRIBUTORS CORP]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXLORATADINE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3LORATADINE SOLUTION [REBEL DISTRIBUTORS CORP]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3LORATADINE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EULORATADINE SOLUTION [REBEL DISTRIBUTORS CORP]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EULORATADINE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
sodium metabisulfiteINACTIVE INGREDIENT4VON5FNS3CLORATADINE SOLUTION [REBEL DISTRIBUTORS CORP]1
sodium metabisulfiteINACTIVE INGREDIENT4VON5FNS3CLORATADINE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
sucroseINACTIVE INGREDIENTC151H8M554LORATADINE SOLUTION [REBEL DISTRIBUTORS CORP]1
sucroseINACTIVE INGREDIENTC151H8M554LORATADINE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RLORATADINE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RLORATADINE SOLUTION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2073CHILDRENS LORATADINE (LORATADINE) SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]6Current NDC, Legacy NDC, 6 package rows20250519_78e11f1c-c8a4-4b2a-b7dc-ae1b2dea26d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSN78e11f1c-c8a4-4b2a-b7dc-ae1b2dea26d07
692783loratadine 1 MG/ML Oral SolutionSCD78e11f1c-c8a4-4b2a-b7dc-ae1b2dea26d07
692783loratadine 5 MG per 5 ML Oral SolutionSY78e11f1c-c8a4-4b2a-b7dc-ae1b2dea26d07
692783loratadine 5 MG in 5 mL Oral SolutionPSN32f9efb1-3ab9-4d3c-a3b3-fd94874bea981
692783loratadine 5 MG in 5 mL Oral SolutionPSN92f728c4-7cc9-4bef-b8a7-94df3f72cc441
692783loratadine 1 MG/ML Oral SolutionSCD32f9efb1-3ab9-4d3c-a3b3-fd94874bea981
692783loratadine 1 MG/ML Oral SolutionSCD92f728c4-7cc9-4bef-b8a7-94df3f72cc441
692783loratadine 5 MG per 5 ML Oral SolutionSY32f9efb1-3ab9-4d3c-a3b3-fd94874bea981
692783loratadine 5 MG per 5 ML Oral SolutionSY92f728c4-7cc9-4bef-b8a7-94df3f72cc441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-2073-4516722073041 BOTTLE in 1 CARTON (51672-2073-4) / 60 mL in 1 BOTTLE1 bottle2004-08-200000-00-00NoNoCurrent
51672-2073-5516722073051 BOTTLE in 1 CARTON (51672-2073-5) / 180 mL in 1 BOTTLE1 bottle2004-08-200000-00-00NoNoCurrent
51672-2073-8516722073081 BOTTLE in 1 CARTON (51672-2073-8) / 120 mL in 1 BOTTLE1 bottle2004-08-200000-00-00NoNoCurrent