CHILDRENS LORATADINE

Product NDC
21130-999
11-digit product format
211300999
Labeler code
21130
Product ID
21130-999_2a75e238-1aba-496e-e063-6394a90a7c64
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
SAFEWAY
Application
ANDA210088
Marketing category
ANDA
Marketing start
2019-07-01
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
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
21130-999-20CHILDRENS LORATADINE2 in 1 CARTONTABLET, CHEWABLE23
21130-999-20CHILDRENS LORATADINE10 in 1 BLISTER PACKTABLET, CHEWABLE103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-999CHILDRENS LORATADINE (LORATADINE) TABLET, CHEWABLE [SAFEWAY]3Current NDC, Legacy NDC, 2 package rows20250101_dad93ac1-ae0b-4918-8c62-92107e79a4b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
665078loratadine 5 MG 24HR Chewable TabletPSNdad93ac1-ae0b-4918-8c62-92107e79a4b23
665078loratadine 5 MG Chewable TabletSCDdad93ac1-ae0b-4918-8c62-92107e79a4b23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-999-20211300999202 BLISTER PACK in 1 CARTON (21130-999-20) / 10 TABLET, CHEWABLE in 1 BLISTER PACK2 blister pack2019-07-010000-00-00NoNoCurrent