Childrens Loratadine

Product NDC
36800-131
11-digit product format
368000131
Labeler code
36800
Product ID
36800-131_75ea11b2-e18d-4790-948d-502ba15ead27
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
Topco Associates 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
36800-131-082021-01-29C16284748780-1ba0f9c33-41d9-a910-e053-dadaa90a0b85Children's Loratadine Oral Solution Sugar Free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-131-08Childrens Loratadine Sugar Free1 in 1 CARTONSOLUTION12
36800-131-08Childrens Loratadine Sugar Free120 mL in 1 BOTTLESOLUTION1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-131-08ML - Milliliter36800-13138f9d022-25f6-4a70-ace6-568efa95ef4012024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-131CHILDRENS LORATADINE SUGAR FREE (LORATADINE) SOLUTION [TOPCO ASSOCIATES LLC]2Legacy NDC, 2 package rows20180825_46161a81-f476-44f1-b93c-57869d351bd7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSN46161a81-f476-44f1-b93c-57869d351bd72
692783loratadine 1 MG/ML Oral SolutionSCD46161a81-f476-44f1-b93c-57869d351bd72
692783loratadine 5 MG per 5 ML Oral SolutionSY46161a81-f476-44f1-b93c-57869d351bd72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
36800-131-08368000131081 in 1 CARTONHistorical