Loratadine

Product NDC
55154-4976
11-digit product format
551544976
Labeler code
55154
Product ID
55154-4976_aa26d526-c64c-46c0-8291-2d5b7c3a5ea6
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA076134
Marketing category
ANDA
Marketing start
2013-06-14
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
55154-4976-0Loratadine10 in 1 BAGTABLET1012
55154-4976-0Loratadine1 in 1 BLISTER PACKTABLET112

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-4976LORATADINE TABLET [CARDINAL HEALTH 107, LLC]11Current NDC, Legacy NDC, 2 package rows20240915_64489b01-a4a7-4c6d-ac84-1dfbd1388d84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN64489b01-a4a7-4c6d-ac84-1dfbd1388d8412
311372loratadine 10 MG Oral TabletSCD64489b01-a4a7-4c6d-ac84-1dfbd1388d8412
311372loratadine 10 MG 24 HR Oral TabletSY64489b01-a4a7-4c6d-ac84-1dfbd1388d8412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-4976-05515449760010 BLISTER PACK in 1 BAG (55154-4976-0) / 1 TABLET in 1 BLISTER PACK10 blister pack2013-06-140000-00-00NoNoCurrent