Childrens Loratadine Oral

Product NDC
81646-106
11-digit product format
816460106
Labeler code
81646
Product ID
81646-106_7ebdeef4-208a-4aff-9b86-4506dd9a08aa
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
PINNACLE PHARMA LLC
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81646-106-052023-01-30C16284748780-1f386c64a-0eb4-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Children’s Loratadine Oral Solution Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81646-106-05Childrens Loratadine Oral5 mL in 1 CUP, UNIT-DOSESOLUTION55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81646-106CHILDRENS LORATADINE ORAL (LORATADINE) SOLUTION [PINNACLE PHARMA LLC]5Legacy NDC, 1 package rows20210515_77a4eae9-695f-49fb-82e0-f05b7cf7391e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSN77a4eae9-695f-49fb-82e0-f05b7cf7391e5
692783loratadine 1 MG/ML Oral SolutionSCD77a4eae9-695f-49fb-82e0-f05b7cf7391e5
692783loratadine 5 MG per 5 ML Oral SolutionSY77a4eae9-695f-49fb-82e0-f05b7cf7391e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81646-106-05816460106055 mL in 1 CUP, UNIT-DOSE (81646-106-05) 5 ml2019-02-120000-00-00NoNoCurrent