DYE-FREE CHILDRENS LORATADINE

Product NDC
11673-111
11-digit product format
116730111
Labeler code
11673
Product ID
11673-111_b9e6809c-e0ce-4205-98c5-665af1716503
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
UP & UP
Application
ANDA210088
Marketing category
ANDA
Marketing start
2020-11-17
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
DYE-FREE CHILDRENS LORATADINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui665078

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-111-30DYE-FREE CHILDRENS LORATADINE10 in 1 BLISTER PACKTABLET, CHEWABLE102
11673-111-30DYE-FREE CHILDRENS LORATADINE3 in 1 CARTONTABLET, CHEWABLE32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-111DYE-FREE CHILDRENS LORATADINE (LORATADINE) TABLET, CHEWABLE [UP & UP]2Current NDC, Legacy NDC, 2 package rows20201124_9660f7e6-3a29-4a6d-ba57-92088f624aa4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
665078loratadine 5 MG 24HR Chewable TabletPSN9660f7e6-3a29-4a6d-ba57-92088f624aa42
665078loratadine 5 MG Chewable TabletSCD9660f7e6-3a29-4a6d-ba57-92088f624aa42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-111-30116730111303 BLISTER PACK in 1 CARTON (11673-111-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK3 blister pack2020-11-170000-00-00NoNoCurrent