FDA.reportPublic FDA data

Loratadine

Product NDC
0363-0522
11-digit product format
003630522
Labeler code
0363
Product ID
0363-0522_6008397f-edfc-42d0-9d3e-29ff5140cf60
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Walgreen Company
Application
ANDA076134
Marketing category
ANDA
Marketing start
2013-12-05
Marketing end
0000-00-00
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-0522-212023-01-30C16284748780-1f386c649-a274-0266-e053-dadaa90a7c1aDrug Facts
0363-0522-302023-01-30C16284748780-1f386c649-a274-0266-e053-dadaa90a7c1aDrug Facts
0363-0522-432023-01-30C16284748780-1f386c649-a274-0266-e053-dadaa90a7c1aDrug Facts
0363-0522-552023-01-30C16284748780-1f386c649-a274-0266-e053-dadaa90a7c1aDrug Facts
0363-0522-562023-01-30C16284748780-1f386c649-a274-0266-e053-dadaa90a7c1aDrug Facts
0363-0522-692023-01-30C16284748780-1f386c649-a274-0266-e053-dadaa90a7c1aDrug Facts
0363-0522-712023-01-30C16284748780-1f386c649-a274-0266-e053-dadaa90a7c1aDrug Facts
0363-0522-782023-01-30C16284748780-1f386c649-a274-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0522-21Loratadine10 in 1 BLISTER PACKTABLET103
0363-0522-21Loratadine2 in 1 CARTONTABLET23
0363-0522-30Loratadine1 in 1 CARTONTABLET13
0363-0522-30Loratadine30 in 1 BOTTLETABLET303
0363-0522-43Loratadine1 in 1 CARTONTABLET13
0363-0522-43Loratadine45 in 1 BOTTLETABLET453
0363-0522-55Loratadine1 in 1 CARTONTABLET13
0363-0522-55Loratadine150 in 1 BOTTLETABLET1503
0363-0522-56Loratadine1 in 1 CARTONTABLET13
0363-0522-56Loratadine5 in 1 BLISTER PACKTABLET53
0363-0522-69Loratadine1 in 1 CARTONTABLET13
0363-0522-69Loratadine10 in 1 BLISTER PACKTABLET103
0363-0522-71Loratadine70 in 1 BOTTLETABLET703
0363-0522-71Loratadine1 in 1 CARTONTABLET13
0363-0522-78Loratadine1 in 1 CARTONTABLET13
0363-0522-78Loratadine300 in 1 BOTTLETABLET3003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0522-56EA - Each0363-052201d99757-501e-418c-99e2-42d7358a06a112022-06-06
0363-0522-78EA - Each0363-0522ee801b2d-8d8a-4a27-9328-3ade78de8be712016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNLORATADINE TABLET [WALGREEN COMPANY]2
LORATADINEACTIVE MOIETY7AJO3BO7QNLORATADINE TABLET [WALGREEN COMPANY]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORATADINE TABLET [WALGREEN COMPANY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORATADINE TABLET [WALGREEN COMPANY]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLORATADINE TABLET [WALGREEN COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0522LORATADINE TABLET [WALGREEN COMPANY]3Legacy NDC, 16 package rows20180615_636d7948-1974-49e7-9571-7a7c3463c415.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN636d7948-1974-49e7-9571-7a7c3463c4153
311372loratadine 10 MG Oral TabletSCD636d7948-1974-49e7-9571-7a7c3463c4153
311372loratadine 10 MG 24 HR Oral TabletSY636d7948-1974-49e7-9571-7a7c3463c4153

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0522-21003630522212 BLISTER PACK in 1 CARTON (0363-0522-21) > 10 TABLET in 1 BLISTER PACK2 blister pack2013-12-050000-00-00NoNoCurrent
0363-0522-30003630522301 BOTTLE in 1 CARTON (0363-0522-30) > 30 TABLET in 1 BOTTLE1 bottle2013-12-050000-00-00NoNoCurrent
0363-0522-43003630522431 BOTTLE in 1 CARTON (0363-0522-43) > 45 TABLET in 1 BOTTLE1 bottle2013-12-050000-00-00NoNoCurrent
0363-0522-55003630522551 BOTTLE in 1 CARTON (0363-0522-55) > 150 TABLET in 1 BOTTLE1 bottle2013-12-050000-00-00NoNoCurrent
0363-0522-56003630522561 BLISTER PACK in 1 CARTON (0363-0522-56) > 5 TABLET in 1 BLISTER PACK1 blister pack2013-12-050000-00-00NoNoCurrent
0363-0522-69003630522691 BLISTER PACK in 1 CARTON (0363-0522-69) > 10 TABLET in 1 BLISTER PACK1 blister pack2013-12-050000-00-00NoNoCurrent
0363-0522-71003630522711 BOTTLE in 1 CARTON (0363-0522-71) > 70 TABLET in 1 BOTTLE1 bottle2013-12-050000-00-00NoNoCurrent
0363-0522-78003630522781 BOTTLE in 1 CARTON (0363-0522-78) > 300 TABLET in 1 BOTTLE1 bottle2013-12-050000-00-00NoNoCurrent