FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
33261-357
11-digit product format
332610357
Labeler code
33261
Product ID
33261-357_fffb5cb3-6568-4027-80b4-8bd01a4769ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA040301
Marketing category
ANDA
Marketing start
1999-07-15
Marketing end
0000-00-00
Substance
WARFARIN SODIUM
Active strength
5 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
33261-357-102020-01-31C16284748780-19d75b9d0-cdc0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Warfarin Sodium Tablets USP, for oral use Initial U.S. Approval: 1954
33261-357-302020-01-31C16284748780-19d75b9d0-cdc0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Warfarin Sodium Tablets USP, for oral use Initial U.S. Approval: 1954
33261-357-602020-01-31C16284748780-19d75b9d0-cdc0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Warfarin Sodium Tablets USP, for oral use Initial U.S. Approval: 1954
33261-357-902020-01-31C16284748780-19d75b9d0-cdc0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. Warfarin Sodium Tablets USP, for oral use Initial U.S. Approval: 1954

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-357-10Warfarin Sodium10 in 1 BOTTLE, PLASTICTABLET101
33261-357-30Warfarin Sodium30 in 1 BOTTLE, PLASTICTABLET301
33261-357-60Warfarin Sodium60 in 1 BOTTLE, PLASTICTABLET601
33261-357-90Warfarin Sodium90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-357WARFARIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20140213_46a207ef-eccd-4f40-a2b1-b782479fb008.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855288warfarin sodium 1 MG Oral TabletPSN46a207ef-eccd-4f40-a2b1-b782479fb0081
855302warfarin sodium 2 MG Oral TabletPSN46a207ef-eccd-4f40-a2b1-b782479fb0081
855332warfarin sodium 5 MG Oral TabletPSN46a207ef-eccd-4f40-a2b1-b782479fb0081
855288warfarin sodium 1 MG Oral TabletSCD46a207ef-eccd-4f40-a2b1-b782479fb0081
855302warfarin sodium 2 MG Oral TabletSCD46a207ef-eccd-4f40-a2b1-b782479fb0081
855332warfarin sodium 5 MG Oral TabletSCD46a207ef-eccd-4f40-a2b1-b782479fb0081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-357-103326103571010 in 1 BOTTLE, PLASTICHistorical
33261-357-303326103573030 in 1 BOTTLE, PLASTICHistorical
33261-357-603326103576060 in 1 BOTTLE, PLASTICHistorical
33261-357-903326103579090 in 1 BOTTLE, PLASTICHistorical