FDA.reportPublic FDA data

Claritin

Product NDC
11523-4329
11-digit product format
115234329
Labeler code
11523
Product ID
11523-4329_4536fe84-5b46-ca4c-e063-6394a90ad03a
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Bayer Healthcare LLC.
Application
NDA020704
Marketing category
NDA
Marketing start
2002-11-27
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
Claritin
Brand name suffix
Reditabs
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui311373, 744830

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-4329-1ClaritinReditabs3 in 1 CARTONTABLET, ORALLY DISINTEGRATING312
11523-4329-1ClaritinReditabs2 in 1 PACKAGE, COMBINATIONTABLET, ORALLY DISINTEGRATING212
11523-4329-2ClaritinReditabs10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1012
11523-4329-2ClaritinReditabs6 in 1 CARTONTABLET, ORALLY DISINTEGRATING612

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-4329-1EA - Each11523-4329cf5c942c-756e-460f-b41f-0686f81799e112015-10-02
11523-4329-2EA - Each11523-4329971dca07-9616-4400-b367-5b35cd2c98f412024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LoratadineACTIVE INGREDIENT7AJO3BO7QNCLARITIN REDITABS (LORATADINE) TABLET, ORALLY DISINTEGRATING [MSD CONSUMER CARE, INC.]4
LoratadineACTIVE MOIETY7AJO3BO7QNCLARITIN REDITABS (LORATADINE) TABLET, ORALLY DISINTEGRATING [MSD CONSUMER CARE, INC.]4
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLCLARITIN REDITABS (LORATADINE) TABLET, ORALLY DISINTEGRATING [MSD CONSUMER CARE, INC.]4
gelatinINACTIVE INGREDIENT2G86QN327LCLARITIN REDITABS (LORATADINE) TABLET, ORALLY DISINTEGRATING [MSD CONSUMER CARE, INC.]4
mannitolINACTIVE INGREDIENT3OWL53L36ACLARITIN REDITABS (LORATADINE) TABLET, ORALLY DISINTEGRATING [MSD CONSUMER CARE, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-4329CLARITIN REDITABS (LORATADINE) TABLET, ORALLY DISINTEGRATING [BAYER HEALTHCARE LLC.]11Current NDC, Legacy NDC, 4 package rows20241208_b681ea25-d00b-4c8a-8054-cc6f983ce337.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
744830Claritin RediTabs 10 MG 24HR Disintegrating Oral TabletPSNb681ea25-d00b-4c8a-8054-cc6f983ce33712
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSNb681ea25-d00b-4c8a-8054-cc6f983ce33712
744830loratadine 10 MG Disintegrating Oral Tablet [Claritin]SBDb681ea25-d00b-4c8a-8054-cc6f983ce33712
311373loratadine 10 MG Disintegrating Oral TabletSCDb681ea25-d00b-4c8a-8054-cc6f983ce33712
744830Claritin 10 MG Disintegrating Oral TabletSYb681ea25-d00b-4c8a-8054-cc6f983ce33712
744830Claritin 24HR RediTabs 10 MG Disintegrating Oral TabletSYb681ea25-d00b-4c8a-8054-cc6f983ce33712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-4329-1115234329012 CARTON in 1 PACKAGE, COMBINATION (11523-4329-1) / 3 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK2 carton2002-11-270000-00-00NoNoCurrent
11523-4329-2115234329026 BLISTER PACK in 1 CARTON (11523-4329-2) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK6 blister pack2002-11-270000-00-00NoNoCurrent