Berkley and Jensen Childrens Allergy Relief

Product NDC
68391-301
11-digit product format
683910301
Labeler code
68391
Product ID
68391-301_6bbf6b94-4346-4a18-9a3b-cf7b034adabf
Type
HUMAN OTC DRUG
Nonproprietary name
loratadine
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
BJWC
Application
ANDA210033
Marketing category
ANDA
Marketing start
2022-01-25
Substance
LORATADINE
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Berkley and Jensen Childrens Allergy Relief
Listing expiration
2027-12-31

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
68391-301-49Berkley and Jensen Childrens Allergy Relief40 in 1 CARTONTABLET, CHEWABLE403
68391-301-49Berkley and Jensen Childrens Allergy Relief1 in 1 BLISTER PACKTABLET, CHEWABLE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-301BERKLEY AND JENSEN CHILDRENS ALLERGY RELIEF (LORATADINE) TABLET, CHEWABLE [BJWC]2Current NDC, Legacy NDC, 2 package rows20231010_7f9b6a94-2be4-4c96-9a7d-8443f911a4cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
665078loratadine 5 MG 24HR Chewable TabletPSN7f9b6a94-2be4-4c96-9a7d-8443f911a4cc3
665078loratadine 5 MG Chewable TabletSCD7f9b6a94-2be4-4c96-9a7d-8443f911a4cc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68391-301-496839103014940 BLISTER PACK in 1 CARTON (68391-301-49) / 1 TABLET, CHEWABLE in 1 BLISTER PACK40 blister pack2022-01-250000-00-00NoNoCurrent