FDA.reportPublic FDA data

Allergy Relief

Product NDC
42507-612
11-digit product format
425070612
Labeler code
42507
Product ID
42507-612_467625f3-8c8f-4894-810e-db1d9c9a51ff
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
HyVee Inc
Application
ANDA076301
Marketing category
ANDA
Marketing start
2005-05-23
Substance
LORATADINE
Active strength
10 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
Allergy Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui311372

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42507-612-00Allergy Relief300 in 1 BOTTLETABLET3006
42507-612-03Allergy Relief1 in 1 CARTONTABLET16
42507-612-30Allergy Relief30 in 1 BOTTLETABLET306
42507-612-46Allergy Relief2 in 1 CARTONTABLET26
42507-612-46Allergy Relief5 in 1 BLISTER PACKTABLET56
42507-612-58Allergy Relief1 in 1 CARTONTABLET16
42507-612-58Allergy Relief40 in 1 BOTTLETABLET406
42507-612-65Allergy Relief1 in 1 CARTONTABLET16
42507-612-70Allergy Relief70 in 1 BOTTLETABLET706
42507-612-72Allergy Relief1 in 1 CARTONTABLET16
42507-612-72Allergy Relief60 in 1 BOTTLETABLET606
42507-612-87Allergy Relief1 in 1 CARTONTABLET16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNALLERGY RELIEF (LORATADINE) TABLET [HYVEE INC]3
LORATADINEACTIVE MOIETY7AJO3BO7QNALLERGY RELIEF (LORATADINE) TABLET [HYVEE INC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLERGY RELIEF (LORATADINE) TABLET [HYVEE INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY RELIEF (LORATADINE) TABLET [HYVEE INC]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EALLERGY RELIEF (LORATADINE) TABLET [HYVEE INC]3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNb6ee2b7f-8e01-4962-b28f-91e5cac852766
311372loratadine 10 MG Oral TabletSCDb6ee2b7f-8e01-4962-b28f-91e5cac852766
311372loratadine 10 MG 24 HR Oral TabletSYb6ee2b7f-8e01-4962-b28f-91e5cac852766

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42507-612-0042507061200300 in 1 BOTTLEHistorical
42507-612-03425070612031 BOTTLE in 1 CARTON (42507-612-03) / 70 TABLET in 1 BOTTLE (42507-612-70) 1 bottle2014-05-03NoNoCurrent
42507-612-304250706123030 in 1 BOTTLEHistorical
42507-612-46425070612462 BLISTER PACK in 1 CARTON (42507-612-46) / 5 TABLET in 1 BLISTER PACK2 blister pack2005-06-12NoNoCurrent
42507-612-58425070612581 in 1 CARTONHistorical
42507-612-65425070612651 BOTTLE in 1 CARTON (42507-612-65) / 30 TABLET in 1 BOTTLE (42507-612-30) 1 bottle2005-05-23NoNoCurrent
42507-612-704250706127070 in 1 BOTTLEHistorical
42507-612-72425070612721 in 1 CARTONHistorical
42507-612-87425070612871 BOTTLE in 1 CARTON (42507-612-87) / 300 TABLET in 1 BOTTLE (42507-612-00) 1 bottle2008-08-18NoNoCurrent