FDA.reportPublic FDA data

Claritin

Product NDC
11523-0104
11-digit product format
115230104
Labeler code
11523
Product ID
11523-0104_4526d753-7999-0ec3-e063-6294a90a270f
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
ANDA210033
Marketing category
ANDA
Marketing start
2023-02-05
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui665078, 668469

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0104-1Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1017
11523-0104-1Claritin1 in 1 CARTONTABLET, CHEWABLE117
11523-0104-2Claritin2 in 1 CARTONTABLET, CHEWABLE217
11523-0104-2Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1017
11523-0104-3Claritin3 in 1 CARTONTABLET, CHEWABLE317
11523-0104-3Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1017
11523-0104-4Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1017
11523-0104-4Claritin4 in 1 CARTONTABLET, CHEWABLE417
11523-0104-5Claritin6 in 1 CARTONTABLET, CHEWABLE617
11523-0104-5Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1017
11523-0104-6Claritin8 in 1 CARTONTABLET, CHEWABLE817
11523-0104-6Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-0104CLARITIN (LORATADINE) TABLET, CHEWABLE [BAYER HEALTHCARE LLC.]16Current NDC, 12 package rows20241208_f3b9c643-a605-7702-e053-2995a90a6130.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
668469Claritin Children's 5 MG 24HR Chewable TabletPSNf3b9c643-a605-7702-e053-2995a90a613017
665078loratadine 5 MG 24HR Chewable TabletPSNf3b9c643-a605-7702-e053-2995a90a613017
668469loratadine 5 MG Chewable Tablet [Claritin]SBDf3b9c643-a605-7702-e053-2995a90a613017
665078loratadine 5 MG Chewable TabletSCDf3b9c643-a605-7702-e053-2995a90a613017
668469Claritin 5 MG Chewable TabletSYf3b9c643-a605-7702-e053-2995a90a613017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11523-0104-1115230104011 BLISTER PACK in 1 CARTON (11523-0104-1) / 10 TABLET, CHEWABLE in 1 BLISTER PACK1 blister pack2023-02-08NoNoHistorical
11523-0104-2115230104022 BLISTER PACK in 1 CARTON (11523-0104-2) / 10 TABLET, CHEWABLE in 1 BLISTER PACK2 blister pack2023-02-08NoNoHistorical
11523-0104-3115230104033 BLISTER PACK in 1 CARTON (11523-0104-3) / 10 TABLET, CHEWABLE in 1 BLISTER PACK3 blister pack2023-02-08NoNoHistorical
11523-0104-4115230104044 BLISTER PACK in 1 CARTON (11523-0104-4) / 10 TABLET, CHEWABLE in 1 BLISTER PACK4 blister pack2023-02-08NoNoHistorical
11523-0104-5115230104056 BLISTER PACK in 1 CARTON (11523-0104-5) / 10 TABLET, CHEWABLE in 1 BLISTER PACK6 blister pack2023-02-08NoNoHistorical
11523-0104-6115230104068 BLISTER PACK in 1 CARTON (11523-0104-6) / 10 TABLET, CHEWABLE in 1 BLISTER PACK8 blister pack2023-02-05NoNoHistorical