LORATADINE

Product NDC
56062-990
11-digit product format
560620990
Labeler code
56062
Product ID
56062-990_dbe033b9-a76e-4880-8b1d-61d8eda23a20
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
PUBLIX SUPER MARKETS INC
Application
ANDA210088
Marketing category
ANDA
Marketing start
2019-07-31
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
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
56062-990-20LORATADINE2 in 1 CARTONTABLET, CHEWABLE24
56062-990-20LORATADINE10 in 1 BLISTER PACKTABLET, CHEWABLE104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56062-990LORATADINE TABLET, CHEWABLE [PUBLIX SUPER MARKETS INC]4Current NDC, Legacy NDC, 2 package rows20190910_8465d458-b3a7-4ada-a7de-1555942d176b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
665078loratadine 5 MG 24HR Chewable TabletPSN8465d458-b3a7-4ada-a7de-1555942d176b4
665078loratadine 5 MG Chewable TabletSCD8465d458-b3a7-4ada-a7de-1555942d176b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56062-990-20560620990202 BLISTER PACK in 1 CARTON (56062-990-20) / 10 TABLET, CHEWABLE in 1 BLISTER PACK2 blister pack2019-07-310000-00-00NoNoCurrent