Claritin

Product NDC
11523-0800
11-digit product format
115230800
Labeler code
11523
Product ID
11523-0800_4526e2eb-ee8d-3ac4-e063-6394a90a133f
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
11523-0800-1Claritin5 in 1 BLISTER PACKTABLET510
11523-0800-1Claritin1 in 1 CARTONTABLET110
11523-0800-2Claritin100 in 1 BOTTLETABLET10010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-0800CLARITIN (LORATADINE) TABLET [BAYER HEALTHCARE LLC.]9Current NDC, Legacy NDC, 3 package rows20241208_dc65f7ec-bb83-7b29-e053-2995a90a99de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
206805Claritin 24HR Allergy 10 MG Oral TabletPSNdc65f7ec-bb83-7b29-e053-2995a90a99de10
311372loratadine 10 MG 24HR Oral TabletPSNdc65f7ec-bb83-7b29-e053-2995a90a99de10
206805loratadine 10 MG Oral Tablet [Claritin]SBDdc65f7ec-bb83-7b29-e053-2995a90a99de10
311372loratadine 10 MG Oral TabletSCDdc65f7ec-bb83-7b29-e053-2995a90a99de10
206805Claritin 10 MG 24 HR Oral TabletSYdc65f7ec-bb83-7b29-e053-2995a90a99de10
206805Claritin 10 MG Oral TabletSYdc65f7ec-bb83-7b29-e053-2995a90a99de10
311372loratadine 10 MG 24 HR Oral TabletSYdc65f7ec-bb83-7b29-e053-2995a90a99de10
206805Claritin 24HR Allergy 10 MG Oral TabletPSN3c9ad1f8-e8ef-bcd0-e063-6394a90ac20e2
311372loratadine 10 MG 24HR Oral TabletPSN3c9ad1f8-e8ef-bcd0-e063-6394a90ac20e2
206805loratadine 10 MG Oral Tablet [Claritin]SBD3c9ad1f8-e8ef-bcd0-e063-6394a90ac20e2
311372loratadine 10 MG Oral TabletSCD3c9ad1f8-e8ef-bcd0-e063-6394a90ac20e2
206805Claritin 10 MG 24 HR Oral TabletSY3c9ad1f8-e8ef-bcd0-e063-6394a90ac20e2
206805Claritin 10 MG Oral TabletSY3c9ad1f8-e8ef-bcd0-e063-6394a90ac20e2
311372loratadine 10 MG 24 HR Oral TabletSY3c9ad1f8-e8ef-bcd0-e063-6394a90ac20e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-0800-1115230800011 BLISTER PACK in 1 CARTON (11523-0800-1) / 5 TABLET in 1 BLISTER PACK1 blister pack2022-03-160000-00-00NoNoCurrent
11523-0800-211523080002100 TABLET in 1 BOTTLE (11523-0800-2) 100 tablet2022-03-160000-00-00NoNoCurrent