Childrens Loratadine

Product NDC
46122-550
11-digit product format
461220550
Labeler code
46122
Product ID
46122-550_974fbe97-a712-4675-b438-afb924c92b28
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Amerisource Bergen
Application
ANDA210088
Marketing category
ANDA
Marketing start
2018-07-01
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
46122-550-60Childrens Loratadine10 in 1 BLISTER PACKTABLET, CHEWABLE101
46122-550-60Childrens Loratadine2 in 1 CARTONTABLET, CHEWABLE21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-550-60EA - Each46122-550ff0e5a21-1592-4917-9b4f-e73c8758770b12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-550CHILDRENS LORATADINE (LORATADINE) TABLET, CHEWABLE [AMERISOURCE BERGEN]1Current NDC, Legacy NDC, 2 package rows20180813_8ec562d3-9d4c-4e28-bc8e-f725079f603a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
665078loratadine 5 MG 24HR Chewable TabletPSN8ec562d3-9d4c-4e28-bc8e-f725079f603a1
665078loratadine 5 MG Chewable TabletSCD8ec562d3-9d4c-4e28-bc8e-f725079f603a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-550-60461220550602 BLISTER PACK in 1 CARTON (46122-550-60) / 10 TABLET, CHEWABLE in 1 BLISTER PACK2 blister pack2018-07-010000-00-00NoNoCurrent