Loratadine ODT

Product NDC
36800-528
11-digit product format
368000528
Labeler code
36800
Product ID
36800-528_dc5acc2d-e646-4db3-97f2-77e16b4b34ef
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Topco Associates 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
36800-528-692020-01-31C16284748780-19d75b9d0-bfdd-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-528-69Loratadine ODT10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING101

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-528LORATADINE ODT (LORATADINE) TABLET, ORALLY DISINTEGRATING [TOPCO ASSOCIATES LLC]1Legacy NDC, 1 package rows20130110_52e8e5c4-a552-4adf-b71b-9259e7822fae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSN52e8e5c4-a552-4adf-b71b-9259e7822fae1
311373loratadine 10 MG Disintegrating Oral TabletSCD52e8e5c4-a552-4adf-b71b-9259e7822fae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
36800-528-693680005286910 in 1 BLISTER PACKHistorical