TopCare

Product NDC
36800-092
11-digit product format
368000092
Labeler code
36800
Product ID
36800-092_b6906c5c-5554-4a10-9985-1877660a68f1
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA076805
Marketing category
ANDA
Marketing start
2010-02-27
Marketing end
0000-00-00
Substance
LORATADINE
Active strength
5 mg/5mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-092-082020-01-31C16284748780-19d75b9d0-c205-f424-e053-dadaa90a57ceTopCare ® Children's Loratadine Syrup

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-092-08TopCare Childrens Loratadine120 mL in 1 BOTTLESOLUTION1202
36800-092-08TopCare Childrens Loratadine1 in 1 CARTONSOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-092-08ML - Milliliter36800-092cdb23497-2fb9-4f8f-acce-6a074e9fa37612017-10-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-092TOPCARE CHILDRENS LORATADINE (LORATADINE) SOLUTION [TOPCO ASSOCIATES LLC]2Legacy NDC, 2 package rows20130613_b04ba893-a825-4450-a6da-eaed492c0a79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSNb04ba893-a825-4450-a6da-eaed492c0a792
692783loratadine 1 MG/ML Oral SolutionSCDb04ba893-a825-4450-a6da-eaed492c0a792
692783loratadine 5 MG per 5 ML Oral SolutionSYb04ba893-a825-4450-a6da-eaed492c0a792

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
36800-092-0836800009208120 mL in 1 BOTTLE120 mlHistorical