Loratadine

Product NDC
55319-526
11-digit product format
553190526
Labeler code
55319
Product ID
55319-526_a6858dab-fe54-4a85-9321-4ea7d6e022c9
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Family Dollar Services, 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
55319-526-302020-01-31C16284748780-19d75b9d1-0b52-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-526-30Loratadine30 in 1 BOTTLETABLET301

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-526LORATADINE TABLET [FAMILY DOLLAR SERVICES, INC.]1Legacy NDC, 1 package rows20130321_0f7520b3-0d9b-435b-bdeb-e3bc2442a667.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN0f7520b3-0d9b-435b-bdeb-e3bc2442a6671
311372loratadine 10 MG Oral TabletSCD0f7520b3-0d9b-435b-bdeb-e3bc2442a6671
311372loratadine 10 MG 24 HR Oral TabletSY0f7520b3-0d9b-435b-bdeb-e3bc2442a6671

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55319-526-305531905263030 in 1 BOTTLEHistorical