FDA.reportPublic FDA data

Claritin

Product NDC
11523-7200
11-digit product format
115237200
Labeler code
11523
Product ID
11523-7200_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
11523-7200-12025-07-29C16284748780-13b156c62-3193-fb37-e063-e6dba90a4e07Claritin ® Liqui-Gels ®
11523-7200-22025-07-29C16284748780-13b156c62-3193-fb37-e063-e6dba90a4e07Claritin ® Liqui-Gels ®
11523-7200-32025-07-29C16284748780-13b156c62-3193-fb37-e063-e6dba90a4e07Claritin ® Liqui-Gels ®
11523-7200-42025-07-29C16284748780-13b156c62-3193-fb37-e063-e6dba90a4e07Claritin ® Liqui-Gels ®
11523-7200-52025-07-29C16284748780-13b156c62-3193-fb37-e063-e6dba90a4e07Claritin ® Liqui-Gels ®
11523-7200-62025-07-29C16284748780-13b156c62-3193-fb37-e063-e6dba90a4e07Claritin ® Liqui-Gels ®
11523-7200-72025-07-29C16284748780-13b156c62-3193-fb37-e063-e6dba90a4e07Claritin ® Liqui-Gels ®
11523-7200-82025-07-29C16284748780-13b156c62-3193-fb37-e063-e6dba90a4e07Claritin ® Liqui-Gels ®
11523-7200-92025-07-29C16284748780-13b156c62-3193-fb37-e063-e6dba90a4e07Claritin ® Liqui-Gels ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-7200-1ClaritinLiqui-Gels1 in 1 CARTONCAPSULE, LIQUID FILLED113
11523-7200-1ClaritinLiqui-Gels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1013
11523-7200-2ClaritinLiqui-Gels8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED813
11523-7200-2ClaritinLiqui-Gels3 in 1 CARTONCAPSULE, LIQUID FILLED313
11523-7200-3ClaritinLiqui-Gels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1013
11523-7200-3ClaritinLiqui-Gels4 in 1 CARTONCAPSULE, LIQUID FILLED413
11523-7200-4ClaritinLiqui-Gels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1013
11523-7200-4ClaritinLiqui-Gels7 in 1 CARTONCAPSULE, LIQUID FILLED713
11523-7200-5ClaritinLiqui-Gels1 in 1 POUCHCAPSULE, LIQUID FILLED113
11523-7200-6ClaritinLiqui-Gels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1013
11523-7200-6ClaritinLiqui-Gels3 in 1 CARTONCAPSULE, LIQUID FILLED313
11523-7200-7ClaritinLiqui-Gels9 in 1 BLISTER PACKCAPSULE, LIQUID FILLED913
11523-7200-7ClaritinLiqui-Gels5 in 1 CARTONCAPSULE, LIQUID FILLED513
11523-7200-8ClaritinLiqui-Gels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1013
11523-7200-8ClaritinLiqui-Gels4 in 1 CARTONCAPSULE, LIQUID FILLED413
11523-7200-9ClaritinLiqui-Gels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1013
11523-7200-9ClaritinLiqui-Gels6 in 1 CARTONCAPSULE, LIQUID FILLED613

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-7200-1EA - Each11523-7200aadf47aa-87c1-425b-a7f6-67866160edcb12013-02-13
11523-7200-2EA - Each11523-72007facd762-a51d-45fa-94f1-ce08487f429c12013-02-13
11523-7200-3EA - Each11523-720076a5d6cf-4345-48d9-8064-dfa7d481a89812013-02-13
11523-7200-6EA - Each11523-7200bae274e3-4d2c-4f8a-b379-0ac97ba5a8cd12015-03-03
11523-7200-7EA - Each11523-7200c435ae2a-e01a-4fc3-89c0-5b1f9b83e23112015-10-02

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
11523-7200CLARITIN LIQUI-GELS (LORATADINE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC.]12Current NDC, Legacy NDC, 17 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
11523-7200-1115237200011 BLISTER PACK in 1 CARTON (11523-7200-1) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2008-06-160000-00-00NoNoCurrent
11523-7200-2115237200028 in 1 BLISTER PACKHistorical
11523-7200-31152372000310 in 1 BLISTER PACKHistorical
11523-7200-41152372000410 in 1 BLISTER PACKHistorical
11523-7200-5115237200051 in 1 POUCHHistorical
11523-7200-6115237200063 BLISTER PACK in 1 CARTON (11523-7200-6) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK3 blister pack2008-06-160000-00-00NoNoCurrent
11523-7200-7115237200079 in 1 BLISTER PACKHistorical
11523-7200-8115237200084 BLISTER PACK in 1 CARTON (11523-7200-8) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK4 blister pack2008-06-160000-00-00NoNoCurrent
11523-7200-9115237200096 BLISTER PACK in 1 CARTON (11523-7200-9) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK6 blister pack2008-06-160000-00-00NoNoCurrent