Claritin

Product NDC
11523-7160
11-digit product format
115237160
Labeler code
11523
Product ID
11523-7160_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
11523-7160-1Claritin5 in 1 BLISTER PACKTABLET512
11523-7160-1Claritin1 in 1 CARTONTABLET112
11523-7160-2Claritin10 in 1 BLISTER PACKTABLET1012
11523-7160-2Claritin1 in 1 CARTONTABLET112
11523-7160-3Claritin10 in 1 BLISTER PACKTABLET1012
11523-7160-3Claritin2 in 1 CARTONTABLET212
11523-7160-5Claritin10 in 1 BLISTER PACKTABLET1012
11523-7160-5Claritin3 in 1 CARTONTABLET312
11523-7160-6Claritin1 in 1 CARTONTABLET112
11523-7160-6Claritin2 in 1 POUCHTABLET212
11523-7160-7Claritin1 in 1 BLISTER PACKTABLET112
11523-7160-7Claritin1 in 1 POUCHTABLET112
11523-7160-8Claritin1 in 1 CARTONTABLET112
11523-7160-8Claritin60 in 1 BOTTLETABLET6012
11523-7160-9Claritin1 in 1 CARTONTABLET112
11523-7160-9Claritin60 in 1 BOTTLETABLET6012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-7160-1EA - Each11523-7160855a386e-d048-4eb2-bd46-2879970928ae12013-02-13
11523-7160-2EA - Each11523-7160f16535e3-da09-49d8-a400-b4328a9b0ac112013-02-13
11523-7160-3EA - Each11523-71606bdfb32c-53ad-4c7d-85d1-51ff7fa065b712013-02-13
11523-7160-5EA - Each11523-7160a1906c20-1d1d-43af-93a8-9e8abdde3f0c12013-02-13
11523-7160-9EA - Each11523-7160daafcf57-7015-4018-af3f-c0d07661841f12024-05-16

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
11523-7160CLARITIN (LORATADINE) TABLET [BAYER HEALTHCARE LLC.]11Current NDC, Legacy NDC, 16 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
206805Claritin 24HR Allergy 10 MG Oral TabletPSN219ab9c4-d0c4-4256-ab64-66d0260886bd3
206805Claritin 24HR Allergy 10 MG Oral TabletPSN60a5dc14-3f74-8414-e053-2991aa0ad34a3
311372loratadine 10 MG 24HR Oral TabletPSN219ab9c4-d0c4-4256-ab64-66d0260886bd3
311372loratadine 10 MG 24HR Oral TabletPSN60a5dc14-3f74-8414-e053-2991aa0ad34a3
206805loratadine 10 MG Oral Tablet [Claritin]SBD60a5dc14-3f74-8414-e053-2991aa0ad34a3
206805loratadine 10 MG Oral Tablet [Claritin]SBD219ab9c4-d0c4-4256-ab64-66d0260886bd3
311372loratadine 10 MG Oral TabletSCD60a5dc14-3f74-8414-e053-2991aa0ad34a3
311372loratadine 10 MG Oral TabletSCD219ab9c4-d0c4-4256-ab64-66d0260886bd3
206805Claritin 10 MG 24 HR Oral TabletSY219ab9c4-d0c4-4256-ab64-66d0260886bd3
206805Claritin 10 MG 24 HR Oral TabletSY60a5dc14-3f74-8414-e053-2991aa0ad34a3
206805Claritin 10 MG Oral TabletSY60a5dc14-3f74-8414-e053-2991aa0ad34a3
206805Claritin 10 MG Oral TabletSY219ab9c4-d0c4-4256-ab64-66d0260886bd3
311372loratadine 10 MG 24 HR Oral TabletSY60a5dc14-3f74-8414-e053-2991aa0ad34a3
311372loratadine 10 MG 24 HR Oral TabletSY219ab9c4-d0c4-4256-ab64-66d0260886bd3
206805Claritin 24HR Allergy 10 MG Oral TabletPSN677bf76d-e75d-4212-b1f2-eaaf25b27cb72
311372loratadine 10 MG 24HR Oral TabletPSN677bf76d-e75d-4212-b1f2-eaaf25b27cb72
206805loratadine 10 MG Oral Tablet [Claritin]SBD677bf76d-e75d-4212-b1f2-eaaf25b27cb72
311372loratadine 10 MG Oral TabletSCD677bf76d-e75d-4212-b1f2-eaaf25b27cb72
206805Claritin 10 MG 24 HR Oral TabletSY677bf76d-e75d-4212-b1f2-eaaf25b27cb72
206805Claritin 10 MG Oral TabletSY677bf76d-e75d-4212-b1f2-eaaf25b27cb72
311372loratadine 10 MG 24 HR Oral TabletSY677bf76d-e75d-4212-b1f2-eaaf25b27cb72
206805Claritin 24HR Allergy 10 MG Oral TabletPSN8d59f35f-9b84-def8-e053-2995a90aaba71
311372loratadine 10 MG 24HR Oral TabletPSN8d59f35f-9b84-def8-e053-2995a90aaba71
206805loratadine 10 MG Oral Tablet [Claritin]SBD8d59f35f-9b84-def8-e053-2995a90aaba71
311372loratadine 10 MG Oral TabletSCD8d59f35f-9b84-def8-e053-2995a90aaba71
206805Claritin 10 MG 24 HR Oral TabletSY8d59f35f-9b84-def8-e053-2995a90aaba71
206805Claritin 10 MG Oral TabletSY8d59f35f-9b84-def8-e053-2995a90aaba71
311372loratadine 10 MG 24 HR Oral TabletSY8d59f35f-9b84-def8-e053-2995a90aaba71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-7160-1115237160011 BLISTER PACK in 1 CARTON (11523-7160-1) / 5 TABLET in 1 BLISTER PACK1 blister pack1993-04-120000-00-00NoNoCurrent
11523-7160-2115237160021 BLISTER PACK in 1 CARTON (11523-7160-2) / 10 TABLET in 1 BLISTER PACK1 blister pack1993-04-120000-00-00NoNoCurrent
11523-7160-3115237160032 BLISTER PACK in 1 CARTON (11523-7160-3) / 10 TABLET in 1 BLISTER PACK2 blister pack1993-04-120000-00-00NoNoCurrent
11523-7160-5115237160053 BLISTER PACK in 1 CARTON (11523-7160-5) / 10 TABLET in 1 BLISTER PACK3 blister pack1993-04-120000-00-00NoNoCurrent
11523-7160-6115237160061 POUCH in 1 CARTON (11523-7160-6) / 2 TABLET in 1 POUCH1 pouch1993-04-120000-00-00NoNoCurrent
11523-7160-7115237160071 BLISTER PACK in 1 POUCH (11523-7160-7) / 1 TABLET in 1 BLISTER PACK1 blister pack1993-04-120000-00-00NoNoCurrent
11523-7160-8115237160081 BOTTLE in 1 CARTON (11523-7160-8) / 60 TABLET in 1 BOTTLE1 bottle2016-09-010000-00-00NoNoCurrent
11523-7160-9115237160091 BOTTLE in 1 CARTON (11523-7160-9) / 60 TABLET in 1 BOTTLE1 bottle1993-04-120000-00-00NoNoCurrent