Claritin

Product NDC
11523-1527
11-digit product format
115231527
Labeler code
11523
Product ID
11523-1527_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
11523-1527-1Claritin50 in 1 BOXTABLET5012
11523-1527-1Claritin1 in 1 POUCHTABLET112
11523-1527-2Claritin1 in 1 POUCHTABLET112
11523-1527-2Claritin50 in 1 BOXTABLET5012

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
11523-1527CLARITIN (LORATADINE) TABLET [BAYER HEALTHCARE LLC.]11Current NDC, Legacy NDC, 4 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
11523-1527-11152315270150 POUCH in 1 BOX (11523-1527-1) / 1 TABLET in 1 POUCH50 pouch1993-04-120000-00-00NoNoCurrent
11523-1527-21152315270250 POUCH in 1 BOX (11523-1527-2) / 1 TABLET in 1 POUCH50 pouch1993-04-120000-00-00NoNoCurrent