Childrens Loratadine

Product NDC
63941-131
11-digit product format
639410131
Labeler code
63941
Product ID
63941-131_476994be-00fa-4b6a-9542-26fac250e2d2
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
Valu Merchandisers Company
Application
ANDA076805
Marketing category
ANDA
Marketing start
2017-03-17
Marketing end
0000-00-00
Substance
LORATADINE
Active strength
5 mg/5mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63941-131-082025-07-29C16284748780-13b156c62-2c5c-fb37-e063-e6dba90a4e07Children's Loratadine Oral Solution Sugar Free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63941-131-08Childrens LoratadineSugar Free1 in 1 CARTONSOLUTION11
63941-131-08Childrens LoratadineSugar Free120 mL in 1 BOTTLESOLUTION1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-131CHILDRENS LORATADINE SUGAR FREE (LORATADINE) SOLUTION [VALU MERCHANDISERS COMPANY]1Legacy NDC, 2 package rows20171220_ca2e8b28-96d7-4f97-a8d1-4bb7d1ced95d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSNca2e8b28-96d7-4f97-a8d1-4bb7d1ced95d1
692783loratadine 1 MG/ML Oral SolutionSCDca2e8b28-96d7-4f97-a8d1-4bb7d1ced95d1
692783loratadine 5 MG per 5 ML Oral SolutionSYca2e8b28-96d7-4f97-a8d1-4bb7d1ced95d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63941-131-08639410131081 BOTTLE in 1 CARTON (63941-131-08) > 120 mL in 1 BOTTLE1 bottle2017-11-150000-00-00NoNoCurrent