Loratadine

Product NDC
37012-526
11-digit product format
370120526
Labeler code
37012
Product ID
37012-526_21c4e5cc-a1e7-467c-ab88-a2cde5b56c68
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Shopko Stores Operating Co., LLC
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
37012-526-312020-01-31C16284748780-19d75b9d0-dfcf-f424-e053-dadaa90a57ceDrug Facts
37012-526-602020-01-31C16284748780-19d75b9d0-dfcf-f424-e053-dadaa90a57ceDrug Facts
37012-526-692020-01-31C16284748780-19d75b9d0-dfcf-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37012-526-31Loratadine30 in 1 BLISTER PACKTABLET301
37012-526-60Loratadine60 in 1 BOTTLETABLET601
37012-526-69Loratadine10 in 1 BLISTER PACKTABLET101

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNLORATADINE TABLET [SHOPKO STORES OPERATING CO., LLC]1
LORATADINEACTIVE MOIETY7AJO3BO7QNLORATADINE TABLET [SHOPKO STORES OPERATING CO., LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORATADINE TABLET [SHOPKO STORES OPERATING CO., LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORATADINE TABLET [SHOPKO STORES OPERATING CO., LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLORATADINE TABLET [SHOPKO STORES OPERATING CO., LLC]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJLORATADINE TABLET [SHOPKO STORES OPERATING CO., LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37012-526LORATADINE TABLET [SHOPKO STORES OPERATING CO., LLC]1Legacy NDC, 3 package rows20130326_9d8888e6-26d6-48cb-afa1-34880dcf668e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN9d8888e6-26d6-48cb-afa1-34880dcf668e1
311372loratadine 10 MG Oral TabletSCD9d8888e6-26d6-48cb-afa1-34880dcf668e1
311372loratadine 10 MG 24 HR Oral TabletSY9d8888e6-26d6-48cb-afa1-34880dcf668e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
37012-526-313701205263130 in 1 BLISTER PACKHistorical
37012-526-603701205266060 in 1 BOTTLEHistorical
37012-526-693701205266910 in 1 BLISTER PACKHistorical