Loratadine ODT

Product NDC
68016-527
11-digit product format
680160527
Labeler code
68016
Product ID
68016-527_ffe62d63-befe-4308-a676-12b3e179a32b
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Chain Drug Consortium, LLC
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-527-312020-01-31C16284748780-19d75b9d0-4e7f-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-527-31Loratadine ODT30 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING303

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-527LORATADINE ODT (LORATADINE) TABLET, ORALLY DISINTEGRATING [CHAIN DRUG CONSORTIUM, LLC]3Legacy NDC, 1 package rows20151014_26a7a473-3b88-4aa6-be56-da315e7556b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSN26a7a473-3b88-4aa6-be56-da315e7556b63
311373loratadine 10 MG Disintegrating Oral TabletSCD26a7a473-3b88-4aa6-be56-da315e7556b63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68016-527-316801605273130 in 1 BLISTER PACKHistorical