Loratadine

Product NDC
36800-527
11-digit product format
368000527
Labeler code
36800
Product ID
36800-527_7d515ff3-fb50-4129-8d0f-cde4336c7327
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Topcare 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
36800-527-692020-01-31C16284748780-19d75b9d1-173a-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-527-69Loratadine10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING102

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-527LORATADINE TABLET, ORALLY DISINTEGRATING [TOPCARE ASSOCIATES LLC]2Legacy NDC, 1 package rows20130126_777e57a4-a9d7-4c8b-8fbf-d1a1abe2c1f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSN777e57a4-a9d7-4c8b-8fbf-d1a1abe2c1f92
311373loratadine 10 MG Disintegrating Oral TabletSCD777e57a4-a9d7-4c8b-8fbf-d1a1abe2c1f92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
36800-527-693680005276910 in 1 BLISTER PACKHistorical