Childrens Walitin

Product NDC
0363-2108
11-digit product format
003632108
Labeler code
0363
Product ID
0363-2108_ebfab224-98d3-435a-9812-1f16b9b1e8d9
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
Walgreen Company
Application
ANDA201865
Marketing category
ANDA
Marketing start
2016-12-12
Substance
LORATADINE
Active strength
5 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Walitin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui692783, 755478

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-2108-08Childrens Walitin1 in 1 CARTONSOLUTION14
0363-2108-08Childrens Walitin120 mL in 1 BOTTLESOLUTION1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-2108-08ML - Milliliter0363-2108007d9c80-e2ba-4205-8ea9-10faef04549912022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-2108CHILDRENS WALITIN (LORATADINE) SOLUTION [WALGREEN COMPANY]4Current NDC, Legacy NDC, 2 package rows20190118_f7962107-f79a-4a04-af8d-f7b989e51f2c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSNf7962107-f79a-4a04-af8d-f7b989e51f2c4
755478Wal-itin Children's 5 MG in 5 mL Oral SolutionPSNf7962107-f79a-4a04-af8d-f7b989e51f2c4
755478loratadine 1 MG/ML Oral Solution [Wal-itin]SBDf7962107-f79a-4a04-af8d-f7b989e51f2c4
692783loratadine 1 MG/ML Oral SolutionSCDf7962107-f79a-4a04-af8d-f7b989e51f2c4
692783loratadine 5 MG per 5 ML Oral SolutionSYf7962107-f79a-4a04-af8d-f7b989e51f2c4
755478Wal-itin 1 MG/ML Oral SolutionSYf7962107-f79a-4a04-af8d-f7b989e51f2c4
755478Wal-itin Children's 5 MG per 5 ML Oral SolutionSYf7962107-f79a-4a04-af8d-f7b989e51f2c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-2108-08003632108081 BOTTLE in 1 CARTON (0363-2108-08) / 120 mL in 1 BOTTLE1 bottle2016-12-120000-00-00NoNoCurrent