Childrens Loratadine

Product NDC
68016-131
11-digit product format
680160131
Labeler code
68016
Product ID
68016-131_aadedce4-e5e5-4028-8398-612e7a2b5667
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
Pharmacy Value Alliance LLC
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
68016-131-082025-07-29C16284748780-13b156c62-2a25-fb37-e063-e6dba90a4e07Children's Loratadine Oral Solution Sugar Free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-131-08Childrens Loratadine Sugar Free1 in 1 CARTONSOLUTION11
68016-131-08Childrens Loratadine Sugar Free120 mL in 1 BOTTLESOLUTION1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-131CHILDRENS LORATADINE SUGAR FREE (LORATADINE) SOLUTION [PHARMACY VALUE ALLIANCE LLC]1Legacy NDC, 2 package rows20170609_c9efbb43-d418-4287-8a72-721e6625fe79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSNc9efbb43-d418-4287-8a72-721e6625fe791
692783loratadine 1 MG/ML Oral SolutionSCDc9efbb43-d418-4287-8a72-721e6625fe791
692783loratadine 5 MG per 5 ML Oral SolutionSYc9efbb43-d418-4287-8a72-721e6625fe791

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-131-08680160131081 BOTTLE in 1 CARTON (68016-131-08) > 120 mL in 1 BOTTLE1 bottle2017-03-170000-00-00NoNoCurrent