CHILDRENS LORATADINE ODT

Product NDC
0363-4020
11-digit product format
003634020
Labeler code
0363
Product ID
0363-4020_99ea2d7a-6eb5-49a3-bddd-58afafdf8ea7
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
WALGREEN CO.
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
CHILDRENS 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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-4020-84CHILDRENS LORATADINE ODT3 in 1 CARTONTABLET, ORALLY DISINTEGRATING35
0363-4020-84CHILDRENS LORATADINE ODT10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-4020-84EA - Each0363-402070e93b32-ea9b-4fdb-9935-14832dfc950b12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-4020CHILDRENS LORATADINE ODT (LORATADINE) TABLET, ORALLY DISINTEGRATING [WALGREEN CO.]5Current NDC, Legacy NDC, 2 package rows20240602_cd597728-35fb-4e43-85ea-84af802e1983.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSNcd597728-35fb-4e43-85ea-84af802e19835
311373loratadine 10 MG Disintegrating Oral TabletSCDcd597728-35fb-4e43-85ea-84af802e19835

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-4020-84003634020843 BLISTER PACK in 1 CARTON (0363-4020-84) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2018-04-110000-00-00NoNoCurrent