Loratadine

Product NDC
63868-157
11-digit product format
638680157
Labeler code
63868
Product ID
63868-157_f1415ccc-2075-46be-9778-002df4ea835d
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Chain Drug Marketing Association Inc.
Application
ANDA077153
Marketing category
ANDA
Marketing start
2007-08-31
Marketing end
0000-00-00
Substance
LORATADINE
Active strength
10 mg/1
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
63868-157-102020-01-31C16284748780-19d75b9cf-d89b-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-157-10Loratadine10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-157-10EA - Each63868-15713d3192c-7935-4898-984a-fe2ccef565bb12013-03-03

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-157LORATADINE TABLET, ORALLY DISINTEGRATING [CHAIN DRUG MARKETING ASSOCIATION INC.]1Legacy NDC, 1 package rows20130219_7cc8edff-b6fb-4a5f-8053-ebfdd0f8e770.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSN7cc8edff-b6fb-4a5f-8053-ebfdd0f8e7701
311373loratadine 10 MG Disintegrating Oral TabletSCD7cc8edff-b6fb-4a5f-8053-ebfdd0f8e7701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63868-157-106386801571010 in 1 BLISTER PACKHistorical