Loratadine ODT

Product NDC
60000-950
11-digit product format
600000950
Labeler code
60000
Product ID
60000-950_d84e29dc-9c76-4b9c-a260-9d04c5f83bc1
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Ahold U.S.A., Inc,
Application
ANDA208477
Marketing category
ANDA
Marketing start
2018-04-11
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Loratadine ODT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui311373

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60000-950-83Loratadine ODT10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING104
60000-950-83Loratadine ODT1 in 1 CARTONTABLET, ORALLY DISINTEGRATING14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60000-950LORATADINE ODT (LORATADINE) TABLET, ORALLY DISINTEGRATING [AHOLD U.S.A., INC,]4Current NDC, Legacy NDC, 2 package rows20221105_092aec8d-57d5-4487-8e1a-b4b586bee7cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSN092aec8d-57d5-4487-8e1a-b4b586bee7cf4
311373loratadine 10 MG Disintegrating Oral TabletSCD092aec8d-57d5-4487-8e1a-b4b586bee7cf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60000-950-83600000950831 BLISTER PACK in 1 CARTON (60000-950-83) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2018-04-110000-00-00NoNoCurrent