Claritin

Product NDC
11523-4330
11-digit product format
115234330
Labeler code
11523
Product ID
11523-4330_45370735-3f9c-a7f8-e063-6294a90aa0c6
Type
HUMAN OTC DRUG
Nonproprietary name
loratadine
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
NDA021891
Marketing category
NDA
Marketing start
2015-09-25
Substance
LORATADINE
Active strength
5 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
LORATADINE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui665078, 668469

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-4330-1Claritin1 in 1 CARTONTABLET, CHEWABLE18
11523-4330-1Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE108
11523-4330-3Claritin3 in 1 CARTONTABLET, CHEWABLE38
11523-4330-3Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE108
11523-4330-4Claritin4 in 1 CARTONTABLET, CHEWABLE48
11523-4330-4Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-4330-1EA - Each11523-433093078d7d-91a2-4f15-9d81-ac0927cae62412019-01-24
11523-4330-3EA - Each11523-4330bd6f7514-86e5-4922-bbc2-bc60a35caf2a12022-11-07
11523-4330-4EA - Each11523-43307d69a0d5-5c6d-4592-8061-99b8d46374f012022-11-07

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-4330CLARITIN (LORATADINE) TABLET, CHEWABLE [BAYER HEALTHCARE LLC.]7Current NDC, Legacy NDC, 6 package rows20221015_20938e05-bc3e-51aa-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
668469Claritin Children's 5 MG 24HR Chewable TabletPSN20938e05-bc3e-51aa-e054-00144ff88e888
665078loratadine 5 MG 24HR Chewable TabletPSN20938e05-bc3e-51aa-e054-00144ff88e888
668469loratadine 5 MG Chewable Tablet [Claritin]SBD20938e05-bc3e-51aa-e054-00144ff88e888
665078loratadine 5 MG Chewable TabletSCD20938e05-bc3e-51aa-e054-00144ff88e888
668469Claritin 5 MG Chewable TabletSY20938e05-bc3e-51aa-e054-00144ff88e888
668469Claritin Children's 5 MG 24HR Chewable TabletPSN0371368b-dca6-af2f-e063-6394a90a0ac02
665078loratadine 5 MG 24HR Chewable TabletPSN0371368b-dca6-af2f-e063-6394a90a0ac02
668469loratadine 5 MG Chewable Tablet [Claritin]SBD0371368b-dca6-af2f-e063-6394a90a0ac02
665078loratadine 5 MG Chewable TabletSCD0371368b-dca6-af2f-e063-6394a90a0ac02
668469Claritin 5 MG Chewable TabletSY0371368b-dca6-af2f-e063-6394a90a0ac02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-4330-1115234330011 BLISTER PACK in 1 CARTON (11523-4330-1) / 10 TABLET, CHEWABLE in 1 BLISTER PACK1 blister pack2015-09-250000-00-00NoNoCurrent
11523-4330-3115234330033 BLISTER PACK in 1 CARTON (11523-4330-3) / 10 TABLET, CHEWABLE in 1 BLISTER PACK3 blister pack2015-09-250000-00-00NoNoCurrent
11523-4330-4115234330044 BLISTER PACK in 1 CARTON (11523-4330-4) / 10 TABLET, CHEWABLE in 1 BLISTER PACK4 blister pack2015-09-250000-00-00NoNoCurrent