FDA.reportPublic FDA data

allergy relief

Product NDC
59779-612
11-digit product format
597790612
Labeler code
59779
Product ID
59779-612_4fd50f17-7237-4659-bad6-a9e6189fa37c
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA076301
Marketing category
ANDA
Marketing start
2005-01-04
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
59779-612-03allergy relief70 in 1 BOTTLETABLET7015
59779-612-03allergy relief1 in 1 CARTONTABLET115
59779-612-39allergy relief1 in 1 BLISTER PACKTABLET115
59779-612-39allergy relief30 in 1 CARTONTABLET3015
59779-612-46allergy relief10 in 1 CARTONTABLET1015
59779-612-46allergy relief1 in 1 BLISTER PACKTABLET115
59779-612-49allergy relief1 in 1 BLISTER PACKTABLET115
59779-612-49allergy relief40 in 1 CARTONTABLET4015
59779-612-58allergy relief40 in 1 BOTTLETABLET4015
59779-612-58allergy relief1 in 1 CARTONTABLET115
59779-612-60allergy relief1 in 1 BLISTER PACKTABLET115
59779-612-60allergy relief20 in 1 CARTONTABLET2015
59779-612-65allergy relief30 in 1 BOTTLETABLET3015
59779-612-65allergy relief1 in 1 CARTONTABLET115
59779-612-70allergy relief2 in 1 CARTONTABLET215
59779-612-72allergy relief1 in 1 CARTONTABLET115
59779-612-72allergy relief60 in 1 BOTTLETABLET6015
59779-612-75allergy relief90 in 1 BOTTLETABLET9015
59779-612-75allergy relief1 in 1 CARTONTABLET115
59779-612-76allergy relief120 in 1 BOTTLETABLET12015
59779-612-78allergy relief1 in 1 CARTONTABLET115
59779-612-78allergy relief100 in 1 BOTTLETABLET10015
59779-612-88allergy relief365 in 1 BOTTLETABLET36515
59779-612-95allergy relief45 in 1 BOTTLETABLET4515
59779-612-95allergy relief1 in 1 CARTONTABLET115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-612-39EA - Each59779-6124b6a2b5c-1cff-49ce-9472-26a88af4477612018-06-11
59779-612-46EA - Each59779-61212a8bf80-e80f-4623-9274-2a21a3baa37e12018-06-11
59779-612-60EA - Each59779-612f64d3264-2d42-4fb5-a2e1-689cb496a2e112018-06-11
59779-612-70EA - Each59779-612f56030f4-54ee-4104-8851-d6bedc32874512018-06-11
59779-612-72EA - Each59779-6126cfb7423-0597-4a2b-a509-7dd92d6f8eb712017-07-07
59779-612-75EA - Each59779-612c511eaa9-c273-40fe-827c-c43782725b9612018-06-11
59779-612-88EA - Each59779-6122a1f5c1e-b605-4c5c-9a97-aa9524549c6712018-10-11
59779-612-95EA - Each59779-6126bd65528-4655-4f1a-b9b6-576a042b571c12018-06-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNALLERGY RELIEF (LORATADINE) TABLET [CVS PHARMACY]6
LORATADINEACTIVE MOIETY7AJO3BO7QNALLERGY RELIEF (LORATADINE) TABLET [CVS PHARMACY]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLERGY RELIEF (LORATADINE) TABLET [CVS PHARMACY]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY RELIEF (LORATADINE) TABLET [CVS PHARMACY]6
POVIDONESINACTIVE INGREDIENTFZ989GH94EALLERGY RELIEF (LORATADINE) TABLET [CVS PHARMACY]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-612ALLERGY RELIEF (LORATADINE) TABLET [CVS PHARMACY]13Current NDC, Legacy NDC, 25 package rows20240828_0038bc38-c205-4d8d-ab78-1abbcd76829e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN0038bc38-c205-4d8d-ab78-1abbcd76829e15
311372loratadine 10 MG Oral TabletSCD0038bc38-c205-4d8d-ab78-1abbcd76829e15
311372loratadine 10 MG 24 HR Oral TabletSY0038bc38-c205-4d8d-ab78-1abbcd76829e15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-612-03597790612031 BOTTLE in 1 CARTON (59779-612-03) / 70 TABLET in 1 BOTTLE1 bottle2017-10-100000-00-00NoNoCurrent
59779-612-395977906123930 BLISTER PACK in 1 CARTON (59779-612-39) > 1 TABLET in 1 BLISTER PACK30 blister pack2005-01-040000-00-00NoNoCurrent
59779-612-465977906124610 BLISTER PACK in 1 CARTON (59779-612-46) / 1 TABLET in 1 BLISTER PACK10 blister pack2009-01-280000-00-00NoNoCurrent
59779-612-495977906124940 BLISTER PACK in 1 CARTON (59779-612-49) > 1 TABLET in 1 BLISTER PACK40 blister pack2015-12-130000-00-00NoNoCurrent
59779-612-58597790612581 BOTTLE in 1 CARTON (59779-612-58) / 40 TABLET in 1 BOTTLE1 bottle2007-07-26NoNoCurrent
59779-612-605977906126020 BLISTER PACK in 1 CARTON (59779-612-60) > 1 TABLET in 1 BLISTER PACK20 blister pack2009-07-210000-00-00NoNoCurrent
59779-612-65597790612651 BOTTLE in 1 CARTON (59779-612-65) / 30 TABLET in 1 BOTTLE1 bottle2018-04-030000-00-00NoNoCurrent
59779-612-70597790612702 BOTTLE in 1 CARTON (59779-612-70) / 120 TABLET in 1 BOTTLE (59779-612-76) 2 bottle2015-09-040000-00-00NoNoCurrent
59779-612-72597790612721 BOTTLE in 1 CARTON (59779-612-72) > 60 TABLET in 1 BOTTLE1 bottle2009-05-280000-00-00NoNoCurrent
59779-612-75597790612751 BOTTLE in 1 CARTON (59779-612-75) > 90 TABLET in 1 BOTTLE1 bottle2009-05-080000-00-00NoNoCurrent
59779-612-7659779061276120 in 1 BOTTLEHistorical
59779-612-78597790612781 BOTTLE in 1 CARTON (59779-612-78) / 100 TABLET in 1 BOTTLE1 bottle2024-08-22NoNoCurrent
59779-612-8859779061288365 TABLET in 1 BOTTLE (59779-612-88) 365 tablet2018-03-230000-00-00NoNoCurrent
59779-612-95597790612951 BOTTLE in 1 CARTON (59779-612-95) / 45 TABLET in 1 BOTTLE1 bottle2015-09-140000-00-00NoNoCurrent