FDA.reportPublic FDA data

Loratadine

Product NDC
0363-0527
11-digit product format
003630527
Labeler code
0363
Product ID
0363-0527_02b3be0a-9cf0-432e-a486-202d011be12b
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Walgreen Company
Application
ANDA077153
Marketing category
ANDA
Marketing start
2007-08-31
Marketing end
0000-00-00
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-0527-312020-01-31C16284748780-19d75b9d0-032b-f424-e053-dadaa90a57ceDrug Facts
0363-0527-692020-01-31C16284748780-19d75b9d0-032b-f424-e053-dadaa90a57ceDrug Facts
0363-0527-712020-01-31C16284748780-19d75b9d0-032b-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0527-31Loratadine30 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING303
0363-0527-69Loratadine10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING103
0363-0527-71Loratadine70 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING703

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0527-31EA - Each0363-05273b14e67a-1a62-400b-9166-f41867d2e65d12022-06-06
0363-0527-71EA - Each0363-052792e0d36b-a908-4498-9850-c31c771d12f512022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNLORATADINE TABLET, ORALLY DISINTEGRATING [WALGREEN COMPANY]3
LORATADINEACTIVE MOIETY7AJO3BO7QNLORATADINE TABLET, ORALLY DISINTEGRATING [WALGREEN COMPANY]3
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1LORATADINE TABLET, ORALLY DISINTEGRATING [WALGREEN COMPANY]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LORATADINE TABLET, ORALLY DISINTEGRATING [WALGREEN COMPANY]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORATADINE TABLET, ORALLY DISINTEGRATING [WALGREEN COMPANY]3
MANNITOLINACTIVE INGREDIENT3OWL53L36ALORATADINE TABLET, ORALLY DISINTEGRATING [WALGREEN COMPANY]3
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UILORATADINE TABLET, ORALLY DISINTEGRATING [WALGREEN COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0527LORATADINE TABLET, ORALLY DISINTEGRATING [WALGREEN COMPANY]3Legacy NDC, 3 package rows20150401_07e54d8e-e129-4883-b688-a3510597b503.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSN07e54d8e-e129-4883-b688-a3510597b5033
311373loratadine 10 MG Disintegrating Oral TabletSCD07e54d8e-e129-4883-b688-a3510597b5033

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0363-0527-310036305273130 in 1 BLISTER PACKHistorical
0363-0527-690036305276910 in 1 BLISTER PACKHistorical
0363-0527-710036305277170 in 1 BLISTER PACKHistorical