FDA.reportPublic FDA data

COUMADIN

Product NDC
43353-492
11-digit product format
433530492
Labeler code
43353
Product ID
43353-492_6e052f18-f7a6-4e8b-9222-0a12572960b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
warfarin sodium
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, Inc.
Application
NDA009218
Marketing category
NDA
Marketing start
2009-01-01
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
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208
abcfe2f4-1eca-fdc3-341b-b8134a1aec1fProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43353-492-302020-01-31C16284748780-19d75b9cf-d58f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use COUMADIN safely and effectively. See full prescribing information for COUMADIN. COUMADIN (warfarin sodium) tablets, for oral use COUMADIN (warfarin sodium) for injection, for intravenous use Initial U.S. Approval: 1954
43353-492-602020-01-31C16284748780-19d75b9cf-d58f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use COUMADIN safely and effectively. See full prescribing information for COUMADIN. COUMADIN (warfarin sodium) tablets, for oral use COUMADIN (warfarin sodium) for injection, for intravenous use Initial U.S. Approval: 1954

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-492-30COUMADIN30 in 1 BOTTLE, PLASTICTABLET302
43353-492-60COUMADIN90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-492-30EA - Each43353-4924654e731-bb67-4596-a475-93023f60cbac12012-07-24
43353-492-60EA - Each43353-492ccad9432-51c2-4713-bd20-768732c7724012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
warfarin sodiumACTIVE INGREDIENT6153CWM0CLCOUMADIN (WARFARIN SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
warfarinACTIVE MOIETY5Q7ZVV76EICOUMADIN (WARFARIN SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
aluminum hydroxideINACTIVE INGREDIENT5QB0T2IUN0COUMADIN (WARFARIN SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
barium sulfateINACTIVE INGREDIENT25BB7EKE2ECOUMADIN (WARFARIN SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
D&C Red No. 6INACTIVE INGREDIENT481744AI4OCOUMADIN (WARFARIN SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GCOUMADIN (WARFARIN SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKCOUMADIN (WARFARIN SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOACOUMADIN (WARFARIN SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8COUMADIN (WARFARIN SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
lactoseINACTIVE INGREDIENTJ2B2A4N98GCOUMADIN (WARFARIN SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30COUMADIN (WARFARIN SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
starch, tapiocaINACTIVE INGREDIENT24SC3U704ICOUMADIN (WARFARIN SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-492COUMADIN (WARFARIN SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2Legacy NDC, 2 package rows20120815_ba41b963-ec4a-4421-ac93-26654876a6be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855290Coumadin 1 MG Oral TabletPSNba41b963-ec4a-4421-ac93-26654876a6be2
855298Coumadin 10 MG Oral TabletPSNba41b963-ec4a-4421-ac93-26654876a6be2
855320Coumadin 3 MG Oral TabletPSNba41b963-ec4a-4421-ac93-26654876a6be2
855346Coumadin 7.5 MG Oral TabletPSNba41b963-ec4a-4421-ac93-26654876a6be2
855288warfarin sodium 1 MG Oral TabletPSNba41b963-ec4a-4421-ac93-26654876a6be2
855296warfarin sodium 10 MG Oral TabletPSNba41b963-ec4a-4421-ac93-26654876a6be2
855318warfarin sodium 3 MG Oral TabletPSNba41b963-ec4a-4421-ac93-26654876a6be2
855344warfarin sodium 7.5 MG Oral TabletPSNba41b963-ec4a-4421-ac93-26654876a6be2
855290warfarin sodium 1 MG Oral Tablet [Coumadin]SBDba41b963-ec4a-4421-ac93-26654876a6be2
855298warfarin sodium 10 MG Oral Tablet [Coumadin]SBDba41b963-ec4a-4421-ac93-26654876a6be2
855320warfarin sodium 3 MG Oral Tablet [Coumadin]SBDba41b963-ec4a-4421-ac93-26654876a6be2
855346warfarin sodium 7.5 MG Oral Tablet [Coumadin]SBDba41b963-ec4a-4421-ac93-26654876a6be2
855288warfarin sodium 1 MG Oral TabletSCDba41b963-ec4a-4421-ac93-26654876a6be2
855296warfarin sodium 10 MG Oral TabletSCDba41b963-ec4a-4421-ac93-26654876a6be2
855318warfarin sodium 3 MG Oral TabletSCDba41b963-ec4a-4421-ac93-26654876a6be2
855344warfarin sodium 7.5 MG Oral TabletSCDba41b963-ec4a-4421-ac93-26654876a6be2
855290Coumadin 1 MG Oral TabletSYba41b963-ec4a-4421-ac93-26654876a6be2
855298Coumadin 10 MG Oral TabletSYba41b963-ec4a-4421-ac93-26654876a6be2
855320Coumadin 3 MG Oral TabletSYba41b963-ec4a-4421-ac93-26654876a6be2
855346Coumadin 7.5 MG Oral TabletSYba41b963-ec4a-4421-ac93-26654876a6be2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-492-304335304923030 in 1 BOTTLE, PLASTICHistorical
43353-492-604335304926090 in 1 BOTTLE, PLASTICHistorical