Childrens Loratadine

Product NDC
0363-2131
11-digit product format
003632131
Labeler code
0363
Product ID
0363-2131_484b9983-af1d-ceb0-e063-6294a90a9d8a
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
Walgreen Company
Application
ANDA076805
Marketing category
ANDA
Marketing start
2017-03-17
Substance
LORATADINE
Active strength
5 mg/5mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Loratadine
Brand name suffix
Sugar Free
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui692783

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-2131-082026-01-13C16284748780-13b156c62-25dd-fb37-e063-e6dba90a4e07Children's Loratadine Oral Solution Sugar Free
0363-2131-082025-07-29C16284748780-13b156c62-25dd-fb37-e063-e6dba90a4e07Children's Loratadine Oral Solution Sugar Free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-2131-08Childrens LoratadineSugar Free1 in 1 CARTONSOLUTION15
0363-2131-08Childrens LoratadineSugar Free120 mL in 1 BOTTLESOLUTION1205

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-2131-08ML - Milliliter0363-21318e0a8652-3e36-4d6e-a0f7-760bac20b05212022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-2131CHILDRENS LORATADINE SUGAR FREE (LORATADINE) SOLUTION [WALGREEN COMPANY]4Current NDC, Legacy NDC, 2 package rows20231012_42a73448-104a-4c7f-aea0-cef44d15f5f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSN42a73448-104a-4c7f-aea0-cef44d15f5f15
692783loratadine 1 MG/ML Oral SolutionSCD42a73448-104a-4c7f-aea0-cef44d15f5f15
692783loratadine 5 MG per 5 ML Oral SolutionSY42a73448-104a-4c7f-aea0-cef44d15f5f15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-2131-08003632131081 BOTTLE in 1 CARTON (0363-2131-08) / 120 mL in 1 BOTTLE1 bottle2017-06-270000-00-00NoNoCurrent