FDA.reportPublic FDA data

Claritin

Product NDC
11523-7202
11-digit product format
115237202
Labeler code
11523
Product ID
11523-7202_45371bc6-b83d-a96d-e063-6294a90a7c40
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Bayer HealthCare LLC
Application
NDA021993
Marketing category
NDA
Marketing start
2006-12-12
Substance
LORATADINE
Active strength
5 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
LORATADINE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui672558, 904026

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-7202-1ClaritinReditabs3 in 1 CARTONTABLET, ORALLY DISINTEGRATING312
11523-7202-1ClaritinReditabs10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1012
11523-7202-3ClaritinReditabs10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1012
11523-7202-3ClaritinReditabs1 in 1 CARTONTABLET, ORALLY DISINTEGRATING112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-7202-1EA - Each11523-72022d9569c3-1d2b-4a96-a48f-54e4ce505bd912012-07-24
11523-7202-3EA - Each11523-72028c62db1c-bc79-4bd8-aae5-46837fb33bf912012-07-24

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
11523-7202CLARITIN REDITABS (LORATADINE) TABLET, ORALLY DISINTEGRATING [BAYER HEALTHCARE LLC]11Current NDC, Legacy NDC, 4 package rows20241208_7dc04b48-f053-4e4b-a493-9e8286d2a791.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904026Claritin RediTabs 5 MG 12HR Disintegrating Oral TabletPSN7dc04b48-f053-4e4b-a493-9e8286d2a79112
672558loratadine 5 MG Disintegrating Oral TabletPSN7dc04b48-f053-4e4b-a493-9e8286d2a79112
904026loratadine 5 MG Disintegrating Oral Tablet [Claritin]SBD7dc04b48-f053-4e4b-a493-9e8286d2a79112
672558loratadine 5 MG Disintegrating Oral TabletSCD7dc04b48-f053-4e4b-a493-9e8286d2a79112
904026Claritin 12HR RediTabs 5 MG Disintegrating Oral TabletSY7dc04b48-f053-4e4b-a493-9e8286d2a79112
904026Claritin 5 MG Disintegrating Oral TabletSY7dc04b48-f053-4e4b-a493-9e8286d2a79112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-7202-1115237202013 BLISTER PACK in 1 CARTON (11523-7202-1) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2006-12-120000-00-00NoNoCurrent
11523-7202-3115237202031 BLISTER PACK in 1 CARTON (11523-7202-3) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2006-12-120000-00-00NoNoCurrent