Childrens Loratadine Oral

Product NDC
68071-2801
11-digit product format
680712801
Labeler code
68071
Product ID
68071-2801_e4b9c21f-ac5b-dc73-e053-2a95a90a1aaa
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA075728
Marketing category
ANDA
Marketing start
2019-02-12
Marketing end
0000-00-00
Substance
LORATADINE
Active strength
5 mg/5mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2801-42025-01-30C16284748780-12cef2736-6c27-d83d-e063-dadaa90ab31fMajor Pharmaceuticals Children’s Loratadine Oral Solution Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2801-4Childrens Loratadine Oral120 mL in 1 BOTTLESOLUTION1201
68071-2801-4Childrens Loratadine Oral1 in 1 CARTONSOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2801CHILDRENS LORATADINE ORAL (LORATADINE) SOLUTION [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 2 package rows20220727_e4b9acaf-ebf6-a925-e053-2a95a90a060b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSNe4b9acaf-ebf6-a925-e053-2a95a90a060b1
692783loratadine 1 MG/ML Oral SolutionSCDe4b9acaf-ebf6-a925-e053-2a95a90a060b1
692783loratadine 5 MG per 5 ML Oral SolutionSYe4b9acaf-ebf6-a925-e053-2a95a90a060b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2801-4680712801041 BOTTLE in 1 CARTON (68071-2801-4) > 120 mL in 1 BOTTLE1 bottle2022-07-260000-00-00NoNoCurrent