FDA.reportPublic FDA data

Claritin

Product NDC
11523-7157
11-digit product format
115237157
Labeler code
11523
Product ID
11523-7157_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
11523-7157-2ClaritinReditabs1 in 1 CARTONTABLET, ORALLY DISINTEGRATING112
11523-7157-2ClaritinReditabs10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1012
11523-7157-3ClaritinReditabs3 in 1 CARTONTABLET, ORALLY DISINTEGRATING312
11523-7157-3ClaritinReditabs10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1012
11523-7157-4ClaritinReditabs2 in 1 CARTONTABLET, ORALLY DISINTEGRATING212
11523-7157-4ClaritinReditabs10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1012
11523-7157-7ClaritinReditabs10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1012
11523-7157-7ClaritinReditabs4 in 1 CARTONTABLET, ORALLY DISINTEGRATING412
11523-7157-8ClaritinReditabs5 in 1 CARTONTABLET, ORALLY DISINTEGRATING512
11523-7157-8ClaritinReditabs10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1012
11523-7157-9ClaritinReditabs10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1012
11523-7157-9ClaritinReditabs7 in 1 CARTONTABLET, ORALLY DISINTEGRATING712

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-7157-2EA - Each11523-7157128f54a2-0776-4dea-a042-44b6442d3b6912012-07-24
11523-7157-3EA - Each11523-7157fd89b497-47a4-4038-a766-17f963a2870b12012-07-24
11523-7157-8EA - Each11523-7157a461ab26-b1e4-4ea2-86d4-61841d1b15a012012-07-24

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
11523-7157CLARITIN REDITABS (LORATADINE) TABLET, ORALLY DISINTEGRATING [BAYER HEALTHCARE LLC.]11Current NDC, Legacy NDC, 12 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
11523-7157-2115237157021 BLISTER PACK in 1 CARTON (11523-7157-2) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2002-11-270000-00-00NoNoCurrent
11523-7157-3115237157033 BLISTER PACK in 1 CARTON (11523-7157-3) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2002-11-270000-00-00NoNoCurrent
11523-7157-4115237157042 BLISTER PACK in 1 CARTON (11523-7157-4) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK2 blister pack2002-11-270000-00-00NoNoCurrent
11523-7157-7115237157074 BLISTER PACK in 1 CARTON (11523-7157-7) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK4 blister pack2002-11-270000-00-00NoNoCurrent
11523-7157-8115237157085 BLISTER PACK in 1 CARTON (11523-7157-8) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK5 blister pack2002-11-270000-00-00NoNoCurrent
11523-7157-9115237157097 BLISTER PACK in 1 CARTON (11523-7157-9) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK7 blister pack2002-11-270000-00-00NoNoCurrent