Loratadine

Product NDC
15127-979
11-digit product format
151270979
Labeler code
15127
Product ID
15127-979_a90cd258-ffa6-44e9-aaa0-04bdae94487e
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Select Brand
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
15127-979-102020-01-31C16284748780-19d75b9d0-0f5b-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15127-979-10Loratadine10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING101

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNLORATADINE TABLET, ORALLY DISINTEGRATING [SELECT BRAND]1
LORATADINEACTIVE MOIETY7AJO3BO7QNLORATADINE TABLET, ORALLY DISINTEGRATING [SELECT BRAND]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1LORATADINE TABLET, ORALLY DISINTEGRATING [SELECT BRAND]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LORATADINE TABLET, ORALLY DISINTEGRATING [SELECT BRAND]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORATADINE TABLET, ORALLY DISINTEGRATING [SELECT BRAND]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ALORATADINE TABLET, ORALLY DISINTEGRATING [SELECT BRAND]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UILORATADINE TABLET, ORALLY DISINTEGRATING [SELECT BRAND]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15127-979LORATADINE TABLET, ORALLY DISINTEGRATING [SELECT BRAND]1Legacy NDC, 1 package rows20121016_abeae0a6-7f41-45e3-b2ae-145a2e633bc7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSNabeae0a6-7f41-45e3-b2ae-145a2e633bc71
311373loratadine 10 MG Disintegrating Oral TabletSCDabeae0a6-7f41-45e3-b2ae-145a2e633bc71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
15127-979-101512709791010 in 1 BLISTER PACKHistorical