FDA.reportPublic FDA data

Claritin

Product NDC
11523-4359
11-digit product format
115234359
Labeler code
11523
Product ID
11523-4359_4536cd82-d67c-56be-e063-6294a90a7775
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
NDA019658
Marketing category
NDA
Marketing start
1993-04-12
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
11523-4359-1Claritin40 in 1 BOTTLETABLET4012
11523-4359-1Claritin1 in 1 CARTONTABLET112
11523-4359-2Claritin1 in 1 CARTONTABLET112
11523-4359-2Claritin100 in 1 BOTTLETABLET10012
11523-4359-3Claritin90 in 1 BOTTLETABLET9012
11523-4359-3Claritin1 in 1 CARTONTABLET112
11523-4359-4Claritin55 in 1 BOTTLETABLET5512
11523-4359-4Claritin1 in 1 CARTONTABLET112
11523-4359-5Claritin1 in 1 CARTONTABLET112
11523-4359-5Claritin85 in 1 BOTTLETABLET8512
11523-4359-6Claritin110 in 1 BOTTLETABLET11012
11523-4359-6Claritin1 in 1 CARTONTABLET112
11523-4359-7Claritin1 in 1 BLISTER PACKTABLET112
11523-4359-7Claritin115 in 1 BOTTLETABLET11512
11523-4359-8Claritin60 in 1 BOTTLETABLET6012
11523-4359-8Claritin2 in 1 BLISTER PACKTABLET212
11523-4359-9Claritin1 in 1 CARTONTABLET112
11523-4359-9Claritin35 in 1 BOTTLETABLET3512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-4359-1EA - Each11523-4359ec560d72-229c-43c8-b999-35c4b11a066e12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LoratadineACTIVE INGREDIENT7AJO3BO7QNCLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]4
LoratadineACTIVE MOIETY7AJO3BO7QNCLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]4
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]4
magnesium stearateINACTIVE INGREDIENT70097M6I30CLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]4
starch, cornINACTIVE INGREDIENTO8232NY3SJCLARITIN (LORATADINE) TABLET [MSD CONSUMER CARE, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-4359CLARITIN (LORATADINE) TABLET [BAYER HEALTHCARE LLC.]11Current NDC, Legacy NDC, 18 package rows20221015_660ac9df-f1b1-4c89-94dd-9fae0a013f3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
206805Claritin 24HR Allergy 10 MG Oral TabletPSN660ac9df-f1b1-4c89-94dd-9fae0a013f3c12
311372loratadine 10 MG 24HR Oral TabletPSN660ac9df-f1b1-4c89-94dd-9fae0a013f3c12
206805loratadine 10 MG Oral Tablet [Claritin]SBD660ac9df-f1b1-4c89-94dd-9fae0a013f3c12
311372loratadine 10 MG Oral TabletSCD660ac9df-f1b1-4c89-94dd-9fae0a013f3c12
206805Claritin 10 MG 24 HR Oral TabletSY660ac9df-f1b1-4c89-94dd-9fae0a013f3c12
206805Claritin 10 MG Oral TabletSY660ac9df-f1b1-4c89-94dd-9fae0a013f3c12
311372loratadine 10 MG 24 HR Oral TabletSY660ac9df-f1b1-4c89-94dd-9fae0a013f3c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-4359-1115234359011 BOTTLE in 1 CARTON (11523-4359-1) / 40 TABLET in 1 BOTTLE1 bottle1993-04-120000-00-00NoNoCurrent
11523-4359-2115234359021 BOTTLE in 1 CARTON (11523-4359-2) / 100 TABLET in 1 BOTTLE1 bottle1993-04-120000-00-00NoNoCurrent
11523-4359-3115234359031 BOTTLE in 1 CARTON (11523-4359-3) / 90 TABLET in 1 BOTTLE1 bottle2017-11-010000-00-00NoNoCurrent
11523-4359-4115234359041 BOTTLE in 1 CARTON (11523-4359-4) / 55 TABLET in 1 BOTTLE1 bottle2019-02-150000-00-00NoNoCurrent
11523-4359-5115234359051 BOTTLE in 1 CARTON (11523-4359-5) / 85 TABLET in 1 BOTTLE1 bottle2019-02-150000-00-00NoNoCurrent
11523-4359-6115234359061 BOTTLE in 1 CARTON (11523-4359-6) / 110 TABLET in 1 BOTTLE1 bottle2019-12-010000-00-00NoNoCurrent
11523-4359-7115234359071 BOTTLE in 1 BLISTER PACK (11523-4359-7) / 115 TABLET in 1 BOTTLE1 bottle1993-04-120000-00-00NoNoCurrent
11523-4359-8115234359082 BOTTLE in 1 BLISTER PACK (11523-4359-8) / 60 TABLET in 1 BOTTLE2 bottle1993-04-120000-00-00NoNoCurrent
11523-4359-9115234359091 BOTTLE in 1 CARTON (11523-4359-9) / 35 TABLET in 1 BOTTLE1 bottle2019-12-010000-00-00NoNoCurrent