FDA.reportPublic FDA data

Claritin

Product NDC
11523-7333
11-digit product format
115237333
Labeler code
11523
Product ID
11523-7333_4a2b0359-b6f2-ddf9-e063-6294a90aed99
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
NDA021952
Marketing category
NDA
Marketing start
2008-06-16
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Claritin
Brand name suffix
Liqui-Gels
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui828269, 836338

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11523-7333-12025-07-29C16284748780-13b156c62-3193-fb37-e063-e6dba90a4e07Claritin ® Liqui-Gels ®
11523-7333-32025-07-29C16284748780-13b156c62-3193-fb37-e063-e6dba90a4e07Claritin ® Liqui-Gels ®
11523-7333-42025-07-29C16284748780-13b156c62-3193-fb37-e063-e6dba90a4e07Claritin ® Liqui-Gels ®
11523-7333-52025-07-29C16284748780-13b156c62-3193-fb37-e063-e6dba90a4e07Claritin ® Liqui-Gels ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-7333-1ClaritinLiqui-Gels1 in 1 CARTONCAPSULE, LIQUID FILLED113
11523-7333-1ClaritinLiqui-Gels5 in 1 BLISTER PACKCAPSULE, LIQUID FILLED513
11523-7333-3ClaritinLiqui-Gels4 in 1 CARTONCAPSULE, LIQUID FILLED413
11523-7333-3ClaritinLiqui-Gels9 in 1 BLISTER PACKCAPSULE, LIQUID FILLED913
11523-7333-4ClaritinLiqui-Gels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1013
11523-7333-4ClaritinLiqui-Gels7 in 1 CARTONCAPSULE, LIQUID FILLED713
11523-7333-5ClaritinLiqui-Gels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1013
11523-7333-5ClaritinLiqui-Gels10 in 1 CARTONCAPSULE, LIQUID FILLED1013

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LoratadineACTIVE INGREDIENT7AJO3BO7QNCLARITIN LIQUI-GELS (LORATADINE) CAPSULE, LIQUID FILLED [MSD CONSUMER CARE, INC.]3
LoratadineACTIVE MOIETY7AJO3BO7QNCLARITIN LIQUI-GELS (LORATADINE) CAPSULE, LIQUID FILLED [MSD CONSUMER CARE, INC.]3
FD&C blue no. 1INACTIVE INGREDIENTH3R47K3TBDCLARITIN LIQUI-GELS (LORATADINE) CAPSULE, LIQUID FILLED [MSD CONSUMER CARE, INC.]3
gelatinINACTIVE INGREDIENT2G86QN327LCLARITIN LIQUI-GELS (LORATADINE) CAPSULE, LIQUID FILLED [MSD CONSUMER CARE, INC.]3
glycerinINACTIVE INGREDIENTPDC6A3C0OXCLARITIN LIQUI-GELS (LORATADINE) CAPSULE, LIQUID FILLED [MSD CONSUMER CARE, INC.]3
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HCLARITIN LIQUI-GELS (LORATADINE) CAPSULE, LIQUID FILLED [MSD CONSUMER CARE, INC.]3
povidonesINACTIVE INGREDIENTFZ989GH94ECLARITIN LIQUI-GELS (LORATADINE) CAPSULE, LIQUID FILLED [MSD CONSUMER CARE, INC.]3
sorbitolINACTIVE INGREDIENT506T60A25RCLARITIN LIQUI-GELS (LORATADINE) CAPSULE, LIQUID FILLED [MSD CONSUMER CARE, INC.]3
waterINACTIVE INGREDIENT059QF0KO0RCLARITIN LIQUI-GELS (LORATADINE) CAPSULE, LIQUID FILLED [MSD CONSUMER CARE, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-7333CLARITIN LIQUI-GELS (LORATADINE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC.]12Current NDC, Legacy NDC, 8 package rows20240217_8e14b61f-faf6-43a8-a080-75f64514217a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836338Claritin Liqui-Gels 10 MG 24HR Oral CapsulePSN8e14b61f-faf6-43a8-a080-75f64514217a13
828269loratadine 10 MG 24HR Oral CapsulePSN8e14b61f-faf6-43a8-a080-75f64514217a13
836338loratadine 10 MG Oral Capsule [Claritin]SBD8e14b61f-faf6-43a8-a080-75f64514217a13
828269loratadine 10 MG Oral CapsuleSCD8e14b61f-faf6-43a8-a080-75f64514217a13
836338Claritin 10 MG Oral CapsuleSY8e14b61f-faf6-43a8-a080-75f64514217a13
828269loratadine 10 MG 24HR Oral CapsuleSY8e14b61f-faf6-43a8-a080-75f64514217a13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-7333-1115237333011 BLISTER PACK in 1 CARTON (11523-7333-1) / 5 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2008-06-160000-00-00NoNoCurrent
11523-7333-3115237333034 BLISTER PACK in 1 CARTON (11523-7333-3) / 9 CAPSULE, LIQUID FILLED in 1 BLISTER PACK4 blister pack2008-06-160000-00-00NoNoCurrent
11523-7333-4115237333047 BLISTER PACK in 1 CARTON (11523-7333-4) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK7 blister pack2008-06-160000-00-00NoNoCurrent
11523-7333-51152373330510 BLISTER PACK in 1 CARTON (11523-7333-5) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK10 blister pack2008-06-16NoNoHistorical