Childrens Loratadine

Product NDC
46122-423
11-digit product format
461220423
Labeler code
46122
Product ID
46122-423_f8905ca0-2fa9-422e-a42d-7d2b99a07775
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
AmerisourceBergen
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46122-423-262025-07-29C16284748780-13b156c62-2803-fb37-e063-e6dba90a4e07Children's Loratadine Oral Solution Sugar Free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-423-26Childrens Loratadine Sugar Free1 in 1 CARTONSOLUTION11
46122-423-26Childrens Loratadine Sugar Free120 mL in 1 BOTTLESOLUTION1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-423-26ML - Milliliter46122-423521b40fc-24ae-4a95-82f7-5323a9f995bb12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-423CHILDRENS LORATADINE SUGAR FREE (LORATADINE) SOLUTION [AMERISOURCEBERGEN]1Legacy NDC, 2 package rows20171219_311733b1-7de7-486d-bb63-5d6933f0d543.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSN311733b1-7de7-486d-bb63-5d6933f0d5431
692783loratadine 1 MG/ML Oral SolutionSCD311733b1-7de7-486d-bb63-5d6933f0d5431
692783loratadine 5 MG per 5 ML Oral SolutionSY311733b1-7de7-486d-bb63-5d6933f0d5431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-423-26461220423261 BOTTLE in 1 CARTON (46122-423-26) > 120 mL in 1 BOTTLE1 bottle2017-10-060000-00-00NoNoCurrent