FDA.reportPublic FDA data

Claritin

Product NDC
11523-0007
11-digit product format
115230007
Labeler code
11523
Product ID
11523-0007_4526b265-4250-3e71-e063-6294a90a21a8
Type
HUMAN OTC DRUG
Nonproprietary name
loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
ANDA075209
Marketing category
ANDA
Marketing start
2020-12-01
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui206805, 311372

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0007-1Claritin1 in 1 CARTONTABLET112
11523-0007-1Claritin10 in 1 BLISTER PACKTABLET1012
11523-0007-2Claritin10 in 1 BLISTER PACKTABLET1012
11523-0007-2Claritin2 in 1 CARTONTABLET212
11523-0007-3Claritin30 in 1 BOTTLETABLET3012
11523-0007-4Claritin40 in 1 BOTTLETABLET4012
11523-0007-5Claritin45 in 1 BOTTLETABLET4512
11523-0007-6Claritin70 in 1 BOTTLETABLET7012
11523-0007-7Claritin85 in 1 BOTTLETABLET8512
11523-0007-8Claritin115 in 1 BOTTLETABLET11512
11523-0007-8Claritin2 in 1 CARTONTABLET212
11523-0007-9Claritin60 in 1 BOTTLETABLET6012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-0007CLARITIN (LORATADINE) TABLET [BAYER HEALTHCARE LLC.]11Current NDC, Legacy NDC, 12 package rows20240619_acf2d393-53d7-062f-e053-2995a90a0d60.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
206805Claritin 24HR Allergy 10 MG Oral TabletPSNacf2d393-53d7-062f-e053-2995a90a0d6012
311372loratadine 10 MG 24HR Oral TabletPSNacf2d393-53d7-062f-e053-2995a90a0d6012
206805loratadine 10 MG Oral Tablet [Claritin]SBDacf2d393-53d7-062f-e053-2995a90a0d6012
311372loratadine 10 MG Oral TabletSCDacf2d393-53d7-062f-e053-2995a90a0d6012
206805Claritin 10 MG 24 HR Oral TabletSYacf2d393-53d7-062f-e053-2995a90a0d6012
206805Claritin 10 MG Oral TabletSYacf2d393-53d7-062f-e053-2995a90a0d6012
311372loratadine 10 MG 24 HR Oral TabletSYacf2d393-53d7-062f-e053-2995a90a0d6012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-0007-1115230007011 BLISTER PACK in 1 CARTON (11523-0007-1) / 10 TABLET in 1 BLISTER PACK1 blister pack2020-12-010000-00-00NoNoCurrent
11523-0007-2115230007022 BLISTER PACK in 1 CARTON (11523-0007-2) / 10 TABLET in 1 BLISTER PACK2 blister pack2020-12-010000-00-00NoNoCurrent
11523-0007-31152300070330 TABLET in 1 BOTTLE (11523-0007-3) 30 tablet2020-12-010000-00-00NoNoCurrent
11523-0007-41152300070440 TABLET in 1 BOTTLE (11523-0007-4) 40 tablet2020-12-010000-00-00NoNoCurrent
11523-0007-51152300070545 TABLET in 1 BOTTLE (11523-0007-5) 45 tablet2020-12-010000-00-00NoNoCurrent
11523-0007-61152300070670 TABLET in 1 BOTTLE (11523-0007-6) 70 tablet2020-12-01NoNoHistorical
11523-0007-71152300070785 TABLET in 1 BOTTLE (11523-0007-7) 85 tablet2020-12-010000-00-00NoNoCurrent
11523-0007-8115230007082 BOTTLE in 1 CARTON (11523-0007-8) / 115 TABLET in 1 BOTTLE2 bottle2021-07-300000-00-00NoNoCurrent
11523-0007-91152300070960 TABLET in 1 BOTTLE (11523-0007-9) 60 tablet2022-03-160000-00-00NoNoCurrent