Loratadine

Product NDC
59779-528
11-digit product format
597790528
Labeler code
59779
Product ID
59779-528_a6cabd7d-4312-4e21-a04d-bc8bbeafbdfb
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA076134
Marketing category
ANDA
Marketing start
2010-01-08
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Loratadine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui311372

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-528-21Loratadine10 in 1 BLISTER PACKTABLET104
59779-528-21Loratadine2 in 1 CARTONTABLET24
59779-528-31Loratadine10 in 1 BLISTER PACKTABLET104
59779-528-31Loratadine3 in 1 CARTONTABLET34
59779-528-37Loratadine120 in 1 BOTTLETABLET1204
59779-528-37Loratadine2 in 1 CARTONTABLET24
59779-528-38Loratadine365 in 1 BOTTLETABLET3654
59779-528-38Loratadine1 in 1 CARTONTABLET14
59779-528-43Loratadine45 in 1 BOTTLETABLET454
59779-528-43Loratadine1 in 1 CARTONTABLET14
59779-528-56Loratadine1 in 1 CARTONTABLET14
59779-528-56Loratadine5 in 1 BLISTER PACKTABLET54
59779-528-60Loratadine1 in 1 CARTONTABLET14
59779-528-60Loratadine60 in 1 BOTTLETABLET604
59779-528-69Loratadine10 in 1 BLISTER PACKTABLET104
59779-528-69Loratadine1 in 1 CARTONTABLET14
59779-528-93Loratadine30 in 1 BOTTLETABLET304
59779-528-93Loratadine2 in 1 CARTONTABLET24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNLORATADINE TABLET [CVS PHARMACY]2
LORATADINEACTIVE MOIETY7AJO3BO7QNLORATADINE TABLET [CVS PHARMACY]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORATADINE TABLET [CVS PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORATADINE TABLET [CVS PHARMACY]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLORATADINE TABLET [CVS PHARMACY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-528LORATADINE TABLET [CVS PHARMACY]4Current NDC, Legacy NDC, 18 package rows20211222_e63f082c-ff50-43ed-ad2c-598b352413e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNe63f082c-ff50-43ed-ad2c-598b352413e84
311372loratadine 10 MG Oral TabletSCDe63f082c-ff50-43ed-ad2c-598b352413e84
311372loratadine 10 MG 24 HR Oral TabletSYe63f082c-ff50-43ed-ad2c-598b352413e84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-528-21597790528212 BLISTER PACK in 1 CARTON (59779-528-21) / 10 TABLET in 1 BLISTER PACK2 blister pack2010-01-080000-00-00NoNoCurrent
59779-528-31597790528313 BLISTER PACK in 1 CARTON (59779-528-31) / 10 TABLET in 1 BLISTER PACK3 blister pack2010-01-080000-00-00NoNoCurrent
59779-528-37597790528372 BOTTLE in 1 CARTON (59779-528-37) / 120 TABLET in 1 BOTTLE2 bottle2010-01-080000-00-00NoNoCurrent
59779-528-38597790528381 BOTTLE in 1 CARTON (59779-528-38) / 365 TABLET in 1 BOTTLE1 bottle2010-01-080000-00-00NoNoCurrent
59779-528-43597790528431 BOTTLE in 1 CARTON (59779-528-43) / 45 TABLET in 1 BOTTLE1 bottle2010-01-080000-00-00NoNoCurrent
59779-528-56597790528561 BLISTER PACK in 1 CARTON (59779-528-56) / 5 TABLET in 1 BLISTER PACK1 blister pack2010-01-080000-00-00NoNoCurrent
59779-528-60597790528601 BOTTLE in 1 CARTON (59779-528-60) / 60 TABLET in 1 BOTTLE1 bottle2010-01-080000-00-00NoNoCurrent
59779-528-69597790528691 BLISTER PACK in 1 CARTON (59779-528-69) / 10 TABLET in 1 BLISTER PACK1 blister pack2010-01-080000-00-00NoNoCurrent
59779-528-93597790528932 BOTTLE in 1 CARTON (59779-528-93) / 30 TABLET in 1 BOTTLE2 bottle2010-01-080000-00-00NoNoCurrent