FDA.reportPublic FDA data

Loratadine ODT

Product NDC
69842-085
11-digit product format
698420085
Labeler code
69842
Product ID
69842-085_8cfc78bb-55ff-4f1f-97c2-b324b989b034
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
CVS Pharmacy, 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
69842-085-03Loratadine ODT1 in 1 CARTONTABLET, ORALLY DISINTEGRATING16
69842-085-03Loratadine ODT10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING106
69842-085-09Loratadine ODT3 in 1 CARTONTABLET, ORALLY DISINTEGRATING36
69842-085-09Loratadine ODT10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-085-03EA - Each69842-0856aed51fa-f406-49c4-8160-6b1c6c4b9ca512024-03-12
69842-085-09EA - Each69842-08556e6e4be-a443-48b0-992c-db2cd2b24ece12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-085LORATADINE ODT (LORATADINE) TABLET, ORALLY DISINTEGRATING [CVS PHARMACY, INC.]6Current NDC, Legacy NDC, 4 package rows20250321_37443f0d-bda0-4ddc-a2dd-f3daf495cb40.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSN37443f0d-bda0-4ddc-a2dd-f3daf495cb406
311373loratadine 10 MG Disintegrating Oral TabletSCD37443f0d-bda0-4ddc-a2dd-f3daf495cb406

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-085-03698420085031 BLISTER PACK in 1 CARTON (69842-085-03) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2018-04-110000-00-00NoNoCurrent
69842-085-09698420085093 BLISTER PACK in 1 CARTON (69842-085-09) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2018-04-110000-00-00NoNoCurrent