Childrens Loratadine

Product NDC
49035-061
11-digit product format
490350061
Labeler code
49035
Product ID
49035-061_fdf600f7-5fc6-4fa2-8d40-29b38db62e02
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
Wal-Mart Stores Inc
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
49035-061-082025-07-29C16284748780-13b156c62-25da-fb37-e063-e6dba90a4e07Children's Loratadine Oral Solution Sugar Free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-061-08Childrens Loratadine Sugar Free1 in 1 CARTONSOLUTION11
49035-061-08Childrens Loratadine Sugar Free60 mL in 1 BOTTLESOLUTION601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-061-08ML - Milliliter49035-06144d61df5-51a0-436c-a025-d512a808f2b512019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-061CHILDRENS LORATADINE SUGAR FREE (LORATADINE) SOLUTION [WAL-MART STORES INC]1Legacy NDC, 2 package rows20170613_8e504e0d-bfae-4c66-85a2-2fd7debb033a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSN8e504e0d-bfae-4c66-85a2-2fd7debb033a1
692783loratadine 1 MG/ML Oral SolutionSCD8e504e0d-bfae-4c66-85a2-2fd7debb033a1
692783loratadine 5 MG per 5 ML Oral SolutionSY8e504e0d-bfae-4c66-85a2-2fd7debb033a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-061-08490350061081 BOTTLE in 1 CARTON (49035-061-08) > 60 mL in 1 BOTTLE1 bottle2017-03-170000-00-00NoNoCurrent