Loratadine ODT

Product NDC
37012-527
11-digit product format
370120527
Labeler code
37012
Product ID
37012-527_03adedd8-1cda-4e10-a2a2-5680a260809e
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Shopko Stores Operating Co., 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37012-527-312020-01-31C16284748780-19d75b9d1-0ba0-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37012-527-31Loratadine ODT30 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING301

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37012-527LORATADINE ODT (LORATADINE) TABLET, ORALLY DISINTEGRATING [SHOPKO STORES OPERATING CO., LLC]1Legacy NDC, 1 package rows20130323_8d7cedb3-6edc-4e9d-9f18-08158d176fdd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSN8d7cedb3-6edc-4e9d-9f18-08158d176fdd1
311373loratadine 10 MG Disintegrating Oral TabletSCD8d7cedb3-6edc-4e9d-9f18-08158d176fdd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
37012-527-313701205273130 in 1 BLISTER PACKHistorical