Loratadine

Product NDC
41163-526
11-digit product format
411630526
Labeler code
41163
Product ID
41163-526_5c942067-b8bf-49af-bde8-712d558bb304
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
SUPERVALU INC.
Application
ANDA076134
Marketing category
ANDA
Marketing start
2003-08-19
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
41163-526-212020-01-31C16284748780-19d75b9d0-b3d1-f424-e053-dadaa90a57ceDrug Facts
41163-526-302020-01-31C16284748780-19d75b9d0-b3d1-f424-e053-dadaa90a57ceDrug Facts
41163-526-602020-01-31C16284748780-19d75b9d0-b3d1-f424-e053-dadaa90a57ceDrug Facts
41163-526-692020-01-31C16284748780-19d75b9d0-b3d1-f424-e053-dadaa90a57ceDrug Facts
41163-526-902020-01-31C16284748780-19d75b9d0-b3d1-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-526-21Loratadine20 in 1 BLISTER PACKTABLET201
41163-526-30Loratadine30 in 1 BOTTLETABLET301
41163-526-60Loratadine60 in 1 BOTTLETABLET601
41163-526-69Loratadine10 in 1 BLISTER PACKTABLET101
41163-526-90Loratadine90 in 1 BOTTLETABLET901

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNLORATADINE TABLET [SUPERVALU INC.]1
LORATADINEACTIVE MOIETY7AJO3BO7QNLORATADINE TABLET [SUPERVALU INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORATADINE TABLET [SUPERVALU INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORATADINE TABLET [SUPERVALU INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLORATADINE TABLET [SUPERVALU INC.]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJLORATADINE TABLET [SUPERVALU INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-526LORATADINE TABLET [SUPERVALU INC.]1Legacy NDC, 5 package rows20130515_a4a4a50e-f640-4a95-a317-e988edc22db5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNa4a4a50e-f640-4a95-a317-e988edc22db51
311372loratadine 10 MG Oral TabletSCDa4a4a50e-f640-4a95-a317-e988edc22db51
311372loratadine 10 MG 24 HR Oral TabletSYa4a4a50e-f640-4a95-a317-e988edc22db51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
41163-526-214116305262120 in 1 BLISTER PACKHistorical
41163-526-304116305263030 in 1 BOTTLEHistorical
41163-526-604116305266060 in 1 BOTTLEHistorical
41163-526-694116305266910 in 1 BLISTER PACKHistorical
41163-526-904116305269090 in 1 BOTTLEHistorical