FDA.reportPublic FDA data

Quality Choice

Product NDC
63868-156
11-digit product format
638680156
Labeler code
63868
Product ID
63868-156_363c7fea-4d11-4c40-895e-1bcb1d2ffdad
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
Chain Drug Marketing Association
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
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-156-042025-11-20C16284748780-19d75b9d0-6721-f424-e053-dadaa90a57ceb468b62e-629e-4220-a261-f3e4175db07c
63868-156-042020-01-31C16284748780-19d75b9d0-6721-f424-e053-dadaa90a57ceb468b62e-629e-4220-a261-f3e4175db07c

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-156-04ML - Milliliter63868-15627a45405-ba01-4c7a-bba0-ba696200392a12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LoratadineACTIVE INGREDIENT7AJO3BO7QNQUALITY CHOICE CHILDRENS ALLERGY RELIEF (LORATADINE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
LoratadineACTIVE MOIETY7AJO3BO7QNQUALITY CHOICE CHILDRENS ALLERGY RELIEF (LORATADINE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPQUALITY CHOICE CHILDRENS ALLERGY RELIEF (LORATADINE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXQUALITY CHOICE CHILDRENS ALLERGY RELIEF (LORATADINE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3QUALITY CHOICE CHILDRENS ALLERGY RELIEF (LORATADINE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUQUALITY CHOICE CHILDRENS ALLERGY RELIEF (LORATADINE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
sodium metabisulfiteINACTIVE INGREDIENT4VON5FNS3CQUALITY CHOICE CHILDRENS ALLERGY RELIEF (LORATADINE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
sucroseINACTIVE INGREDIENTC151H8M554QUALITY CHOICE CHILDRENS ALLERGY RELIEF (LORATADINE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
waterINACTIVE INGREDIENT059QF0KO0RQUALITY CHOICE CHILDRENS ALLERGY RELIEF (LORATADINE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-156QUALITY CHOICE CHILDRENS ALLERGY RELIEF (LORATADINE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1Legacy NDC20121115_b468b62e-629e-4220-a261-f3e4175db07c.zip