FDA.reportPublic FDA data

Sunmark Loratadine ODT

Product NDC
49348-930
11-digit product format
493480930
Labeler code
49348
Product ID
49348-930_e1e28a49-a526-42b0-8a64-c3546094962f
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Sunmark
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
49348-930-012020-01-31C16284748780-19d75b9d0-2e27-f424-e053-dadaa90a57ceDrug Facts
49348-930-442020-01-31C16284748780-19d75b9d0-2e27-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-930-01Sunmark Loratadine ODT10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING102
49348-930-44Sunmark Loratadine ODT30 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-930-01EA - Each49348-930737252da-9d20-4e22-9913-bfa002f45e8412013-02-13
49348-930-44EA - Each49348-9302e892c48-66bd-4f93-a763-e2834271bb4e12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNSUNMARK LORATADINE ODT (LORATADINE) TABLET, ORALLY DISINTEGRATING [SUNMARK]2
LORATADINEACTIVE MOIETY7AJO3BO7QNSUNMARK LORATADINE ODT (LORATADINE) TABLET, ORALLY DISINTEGRATING [SUNMARK]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1SUNMARK LORATADINE ODT (LORATADINE) TABLET, ORALLY DISINTEGRATING [SUNMARK]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SUNMARK LORATADINE ODT (LORATADINE) TABLET, ORALLY DISINTEGRATING [SUNMARK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUNMARK LORATADINE ODT (LORATADINE) TABLET, ORALLY DISINTEGRATING [SUNMARK]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ASUNMARK LORATADINE ODT (LORATADINE) TABLET, ORALLY DISINTEGRATING [SUNMARK]2
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UISUNMARK LORATADINE ODT (LORATADINE) TABLET, ORALLY DISINTEGRATING [SUNMARK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-930SUNMARK LORATADINE ODT (LORATADINE) TABLET, ORALLY DISINTEGRATING [SUNMARK]2Legacy NDC, 2 package rows20120822_2aa10bc8-4d85-49c8-ad9b-7a555b26fe0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSN2aa10bc8-4d85-49c8-ad9b-7a555b26fe0d2
311373loratadine 10 MG Disintegrating Oral TabletSCD2aa10bc8-4d85-49c8-ad9b-7a555b26fe0d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
49348-930-014934809300110 in 1 BLISTER PACKHistorical
49348-930-444934809304430 in 1 BLISTER PACKHistorical