FDA.reportPublic FDA data

Claritin

Product NDC
11523-7237
11-digit product format
115237237
Labeler code
11523
Product ID
11523-7237_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
11523-7237-1Claritin45 in 1 BOTTLETABLET4512
11523-7237-1Claritin1 in 1 CARTONTABLET112
11523-7237-3Claritin7 in 1 CARTONTABLET712
11523-7237-3Claritin10 in 1 BLISTER PACKTABLET1012
11523-7237-5Claritin1 in 1 BLISTER PACKTABLET112
11523-7237-5Claritin90 in 1 BOTTLETABLET9012
11523-7237-6Claritin5 in 1 BLISTER PACKTABLET512
11523-7237-6Claritin3 in 1 CARTONTABLET312
11523-7237-7Claritin10 in 1 BLISTER PACKTABLET1012
11523-7237-7Claritin4 in 1 CARTONTABLET412
11523-7237-8Claritin108 in 1 BOTTLETABLET10812
11523-7237-8Claritin1 in 1 CARTONTABLET112
11523-7237-9Claritin90 in 1 BOTTLETABLET9012
11523-7237-9Claritin1 in 1 CARTONTABLET112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-7237-1EA - Each11523-7237ab61917f-63b5-4366-8f87-d1f7cece4dab12012-07-24
11523-7237-3EA - Each11523-72374d73af16-11c1-4515-b788-c19718ca66c112013-02-13
11523-7237-5EA - Each11523-723786e26548-7838-430c-959a-26991a6150f512012-07-24
11523-7237-6EA - Each11523-7237732171ac-1653-4f16-9a0b-092b7be6c15712013-02-13
11523-7237-8EA - Each11523-7237693ef1e7-00ee-45ea-8290-46e340be9a4c12013-02-13

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
11523-7237CLARITIN (LORATADINE) TABLET [BAYER HEALTHCARE LLC.]11Current NDC, Legacy NDC, 14 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
11523-7237-1115237237011 BOTTLE in 1 CARTON (11523-7237-1) / 45 TABLET in 1 BOTTLE1 bottle1993-04-120000-00-00NoNoCurrent
11523-7237-3115237237037 BLISTER PACK in 1 CARTON (11523-7237-3) / 10 TABLET in 1 BLISTER PACK7 blister pack1993-08-120000-00-00NoNoCurrent
11523-7237-5115237237051 BOTTLE in 1 BLISTER PACK (11523-7237-5) / 90 TABLET in 1 BOTTLE1 bottle1993-04-120000-00-00NoNoCurrent
11523-7237-6115237237063 BLISTER PACK in 1 CARTON (11523-7237-6) / 5 TABLET in 1 BLISTER PACK3 blister pack1993-04-120000-00-00NoNoCurrent
11523-7237-7115237237074 BLISTER PACK in 1 CARTON (11523-7237-7) / 10 TABLET in 1 BLISTER PACK4 blister pack1993-04-120000-00-00NoNoCurrent
11523-7237-8115237237081 BOTTLE in 1 CARTON (11523-7237-8) / 108 TABLET in 1 BOTTLE1 bottle1993-04-120000-00-00NoNoCurrent
11523-7237-9115237237091 BOTTLE in 1 CARTON (11523-7237-9) / 90 TABLET in 1 BOTTLE1 bottle2017-10-050000-00-00NoNoCurrent