DYE-FREE CHILDRENS LORATADINE

Product NDC
21130-646
11-digit product format
211300646
Labeler code
21130
Product ID
21130-646_23e8d6c0-b88d-47aa-b714-d12313af5157
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
SAFEWAY
Application
ANDA210088
Marketing category
ANDA
Marketing start
2020-09-01
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
21130-646-20DYE-FREE CHILDRENS LORATADINE2 in 1 CARTONTABLET, CHEWABLE22
21130-646-20DYE-FREE CHILDRENS LORATADINE10 in 1 BLISTER PACKTABLET, CHEWABLE102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-646DYE-FREE CHILDRENS LORATADINE (LORATADINE) TABLET, CHEWABLE [SAFEWAY]2Current NDC, Legacy NDC, 2 package rows20210124_7440046f-bf2f-438f-a320-3425d593d1a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
665078loratadine 5 MG 24HR Chewable TabletPSN7440046f-bf2f-438f-a320-3425d593d1a62
665078loratadine 5 MG Chewable TabletSCD7440046f-bf2f-438f-a320-3425d593d1a62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-646-20211300646202 BLISTER PACK in 1 CARTON (21130-646-20) / 10 TABLET, CHEWABLE in 1 BLISTER PACK2 blister pack2020-09-010000-00-00NoNoCurrent