FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
43353-142
11-digit product format
433530142
Labeler code
43353
Product ID
43353-142_b2821ecc-6d75-4ea4-b57c-78ad508fe7e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA040301
Marketing category
ANDA
Marketing start
1999-07-15
Marketing end
0000-00-00
Substance
WARFARIN SODIUM
Active strength
3 mg/1
Pharmacologic classes
Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]
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
abcfe2f4-1eca-fdc3-341b-b8134a1aec1fProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43353-142-302020-01-31C16284748780-19d75b9d1-2b11-f424-e053-dadaa90a57ceWarfarin Sodium Tablets, USP Crystalline
43353-142-402020-01-31C16284748780-19d75b9d1-2b11-f424-e053-dadaa90a57ceWarfarin Sodium Tablets, USP Crystalline
43353-142-452020-01-31C16284748780-19d75b9d1-2b11-f424-e053-dadaa90a57ceWarfarin Sodium Tablets, USP Crystalline
43353-142-532020-01-31C16284748780-19d75b9d1-2b11-f424-e053-dadaa90a57ceWarfarin Sodium Tablets, USP Crystalline
43353-142-602020-01-31C16284748780-19d75b9d1-2b11-f424-e053-dadaa90a57ceWarfarin Sodium Tablets, USP Crystalline

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-142-30Warfarin Sodium30 in 1 BOTTLE, PLASTICTABLET302
43353-142-40Warfarin Sodium40 in 1 BOTTLE, PLASTICTABLET402
43353-142-45Warfarin Sodium45 in 1 BOTTLE, PLASTICTABLET452
43353-142-53Warfarin Sodium60 in 1 BOTTLE, PLASTICTABLET602
43353-142-60Warfarin Sodium90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-142WARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 5 package rows20140507_c437507c-d308-4aac-aa5e-a54972c7fa95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855288warfarin sodium 1 MG Oral TabletPSNc437507c-d308-4aac-aa5e-a54972c7fa952
855296warfarin sodium 10 MG Oral TabletPSNc437507c-d308-4aac-aa5e-a54972c7fa952
855312warfarin sodium 2.5 MG Oral TabletPSNc437507c-d308-4aac-aa5e-a54972c7fa952
855318warfarin sodium 3 MG Oral TabletPSNc437507c-d308-4aac-aa5e-a54972c7fa952
855324warfarin sodium 4 MG Oral TabletPSNc437507c-d308-4aac-aa5e-a54972c7fa952
855332warfarin sodium 5 MG Oral TabletPSNc437507c-d308-4aac-aa5e-a54972c7fa952
855338warfarin sodium 6 MG Oral TabletPSNc437507c-d308-4aac-aa5e-a54972c7fa952
855344warfarin sodium 7.5 MG Oral TabletPSNc437507c-d308-4aac-aa5e-a54972c7fa952
855288warfarin sodium 1 MG Oral TabletSCDc437507c-d308-4aac-aa5e-a54972c7fa952
855296warfarin sodium 10 MG Oral TabletSCDc437507c-d308-4aac-aa5e-a54972c7fa952
855312warfarin sodium 2.5 MG Oral TabletSCDc437507c-d308-4aac-aa5e-a54972c7fa952
855318warfarin sodium 3 MG Oral TabletSCDc437507c-d308-4aac-aa5e-a54972c7fa952
855324warfarin sodium 4 MG Oral TabletSCDc437507c-d308-4aac-aa5e-a54972c7fa952
855332warfarin sodium 5 MG Oral TabletSCDc437507c-d308-4aac-aa5e-a54972c7fa952
855338warfarin sodium 6 MG Oral TabletSCDc437507c-d308-4aac-aa5e-a54972c7fa952
855344warfarin sodium 7.5 MG Oral TabletSCDc437507c-d308-4aac-aa5e-a54972c7fa952

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-142-304335301423030 in 1 BOTTLE, PLASTICHistorical
43353-142-404335301424040 in 1 BOTTLE, PLASTICHistorical
43353-142-454335301424545 in 1 BOTTLE, PLASTICHistorical
43353-142-534335301425360 in 1 BOTTLE, PLASTICHistorical
43353-142-604335301426090 in 1 BOTTLE, PLASTICHistorical