FDA.reportPublic FDA data

COARTEM

Product NDC
76413-154
11-digit product format
764130154
Labeler code
76413
Product ID
76413-154_2e678bdb-4af9-4937-800f-8165778b0fe4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
artemether and lumefantrine
Dosage form
TABLET
Route
ORAL
Labeler
Central Texas Community Health Centers
Application
NDA022268
Marketing category
NDA
Marketing start
2009-04-07
Marketing end
0000-00-00
Substance
ARTEMETHER; LUMEFANTRINE
Active strength
20 mg/1; mg/1
Pharmacologic classes
Antimalarial [EPC],Antimalarial [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b30714ba-10ec-95e1-ea3a-a9eab80dba26Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76413-154-062020-01-31C16284748780-19d75b9d0-612d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use COARTEM Tablets safely and effectively. See full prescribing information for COARTEM Tablets. COARTEM ® (artemether/lumefantrine) Tablets Initial U.S. Approval: 2009
76413-154-122020-01-31C16284748780-19d75b9d0-612d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use COARTEM Tablets safely and effectively. See full prescribing information for COARTEM Tablets. COARTEM ® (artemether/lumefantrine) Tablets Initial U.S. Approval: 2009
76413-154-182020-01-31C16284748780-19d75b9d0-612d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use COARTEM Tablets safely and effectively. See full prescribing information for COARTEM Tablets. COARTEM ® (artemether/lumefantrine) Tablets Initial U.S. Approval: 2009
76413-154-242020-01-31C16284748780-19d75b9d0-612d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use COARTEM Tablets safely and effectively. See full prescribing information for COARTEM Tablets. COARTEM ® (artemether/lumefantrine) Tablets Initial U.S. Approval: 2009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76413-154-06COARTEM6 in 1 BOTTLE, PLASTICTABLET61
76413-154-12COARTEM12 in 1 BOTTLE, PLASTICTABLET121
76413-154-18COARTEM18 in 1 BOTTLE, PLASTICTABLET181
76413-154-24COARTEM24 in 1 BOTTLE, PLASTICTABLET241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76413-154COARTEM (ARTEMETHER AND LUMEFANTRINE) TABLET [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]1Legacy NDC, 4 package rows20170829_66e02264-6917-4185-9c36-9dc64eaaeb23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847731artemether 20 MG / lumefantrine 120 MG Oral TabletPSN66e02264-6917-4185-9c36-9dc64eaaeb231
847734Coartem 20 MG / 120 MG Oral TabletPSN66e02264-6917-4185-9c36-9dc64eaaeb231
847734artemether 20 MG / lumefantrine 120 MG Oral Tablet [Coartem]SBD66e02264-6917-4185-9c36-9dc64eaaeb231
847731artemether 20 MG / lumefantrine 120 MG Oral TabletSCD66e02264-6917-4185-9c36-9dc64eaaeb231
847734Coartem (artemether 20 MG / lumefantrine 120 MG) Oral TabletSY66e02264-6917-4185-9c36-9dc64eaaeb231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
76413-154-06764130154066 in 1 BOTTLE, PLASTICHistorical
76413-154-127641301541212 in 1 BOTTLE, PLASTICHistorical
76413-154-187641301541818 in 1 BOTTLE, PLASTICHistorical
76413-154-247641301542424 in 1 BOTTLE, PLASTICHistorical