Loratadine

Product NDC
37205-378
11-digit product format
372050378
Labeler code
37205
Product ID
37205-378_50612f6b-c83f-451b-a2c0-09d9a542718f
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
Cardinal Health
Application
ANDA076805
Marketing category
ANDA
Marketing start
2004-08-20
Marketing end
0000-00-00
Substance
LORATADINE
Active strength
5 mg/5mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37205-378-26ML - Milliliter37205-37817460fcc-28b7-44e7-9c61-3fa4895820e912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LoratadineACTIVE INGREDIENT7AJO3BO7QNLORATADINE SOLUTION [CARDINAL HEALTH]1
LoratadineACTIVE MOIETY7AJO3BO7QNLORATADINE SOLUTION [CARDINAL HEALTH]1
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPLORATADINE SOLUTION [CARDINAL HEALTH]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXLORATADINE SOLUTION [CARDINAL HEALTH]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3LORATADINE SOLUTION [CARDINAL HEALTH]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EULORATADINE SOLUTION [CARDINAL HEALTH]1
sodium metabisulfiteINACTIVE INGREDIENT4VON5FNS3CLORATADINE SOLUTION [CARDINAL HEALTH]1
sucroseINACTIVE INGREDIENTC151H8M554LORATADINE SOLUTION [CARDINAL HEALTH]1
waterINACTIVE INGREDIENT059QF0KO0RLORATADINE SOLUTION [CARDINAL HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37205-378LORATADINE SOLUTION [CARDINAL HEALTH]3Legacy NDC20241019_6f881bd5-14c4-4077-ad03-1fae2d6ccb3b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37205-378-26372050378261 BOTTLE in 1 CARTON (37205-378-26) > 120 mL in 1 BOTTLE1 bottle2004-08-200000-00-00NoNoCurrent