FDA.reportPublic FDA data

Loratadine

Product NDC
0904-6234
11-digit product format
009046234
Labeler code
0904
Product ID
0904-6234_49e64f31-b499-432d-b0a7-a18c464ce59f
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
Major Pharmaceuticals, Inc
Application
ANDA077421
Marketing category
ANDA
Marketing start
2011-02-17
Marketing end
2020-04-26
Substance
LORATADINE
Active strength
5 mg/5mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6234-20ML - Milliliter0904-6234ec603472-48db-4d13-b80b-603f857bff1d12012-07-24

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSN5a443fa3-a38f-4e4e-b6a0-7773a3d5ec833
692783loratadine 1 MG/ML Oral SolutionSCD5a443fa3-a38f-4e4e-b6a0-7773a3d5ec833
692783loratadine 5 MG per 5 ML Oral SolutionSY5a443fa3-a38f-4e4e-b6a0-7773a3d5ec833