FDA.reportPublic FDA data

COUMADIN

Product NDC
0056-0174
11-digit product format
000560174
Labeler code
0056
Product ID
0056-0174_82eb7d64-8497-483e-b4fe-d1e4b154b7dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
warfarin sodium
Dosage form
TABLET
Route
ORAL
Labeler
Bristol-Myers Squibb Pharma Company
Application
NDA009218
Marketing category
NDA
Marketing start
2009-01-01
Marketing end
0000-00-00
Substance
WARFARIN SODIUM
Active strength
10 mg/1
Pharmacologic classes
Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]
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
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0056-0174-01EA - Each0056-01745fc9680f-73bd-488d-b424-61a4e97097c812012-07-24
0056-0174-70EA - Each0056-017404fd304d-e14e-4b8a-9288-3a7d1fb57f9e12012-07-24
0056-0174-75EA - Each0056-0174190187b5-8acd-4f10-8e19-928a4b1fce2712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
warfarin sodiumACTIVE INGREDIENT6153CWM0CLCOUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]4
warfarinACTIVE MOIETY5Q7ZVV76EICOUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]4
aluminum hydroxideINACTIVE INGREDIENT5QB0T2IUN0COUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]4
barium sulfateINACTIVE INGREDIENT25BB7EKE2ECOUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]4
D&C Red No. 6INACTIVE INGREDIENT481744AI4OCOUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]4
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GCOUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]4
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDCOUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]4
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKCOUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]4
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOACOUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]4
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8COUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]4
lactoseINACTIVE INGREDIENTJ2B2A4N98GCOUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]4
magnesium stearateINACTIVE INGREDIENT70097M6I30COUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]4
starch, tapiocaINACTIVE INGREDIENT24SC3U704ICOUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]4
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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855290Coumadin 1 MG Oral TabletPSN91fa852c-b43d-4a55-983b-74aa6827125d4
855298Coumadin 10 MG Oral TabletPSN91fa852c-b43d-4a55-983b-74aa6827125d4
855304Coumadin 2 MG Oral TabletPSN91fa852c-b43d-4a55-983b-74aa6827125d4
855314Coumadin 2.5 MG Oral TabletPSN91fa852c-b43d-4a55-983b-74aa6827125d4
855320Coumadin 3 MG Oral TabletPSN91fa852c-b43d-4a55-983b-74aa6827125d4
855326Coumadin 4 MG Oral TabletPSN91fa852c-b43d-4a55-983b-74aa6827125d4
855334Coumadin 5 MG Oral TabletPSN91fa852c-b43d-4a55-983b-74aa6827125d4
855340Coumadin 6 MG Oral TabletPSN91fa852c-b43d-4a55-983b-74aa6827125d4
855346Coumadin 7.5 MG Oral TabletPSN91fa852c-b43d-4a55-983b-74aa6827125d4
855288warfarin sodium 1 MG Oral TabletPSN91fa852c-b43d-4a55-983b-74aa6827125d4
855296warfarin sodium 10 MG Oral TabletPSN91fa852c-b43d-4a55-983b-74aa6827125d4
855302warfarin sodium 2 MG Oral TabletPSN91fa852c-b43d-4a55-983b-74aa6827125d4
855312warfarin sodium 2.5 MG Oral TabletPSN91fa852c-b43d-4a55-983b-74aa6827125d4
855318warfarin sodium 3 MG Oral TabletPSN91fa852c-b43d-4a55-983b-74aa6827125d4
855324warfarin sodium 4 MG Oral TabletPSN91fa852c-b43d-4a55-983b-74aa6827125d4
855332warfarin sodium 5 MG Oral TabletPSN91fa852c-b43d-4a55-983b-74aa6827125d4
855338warfarin sodium 6 MG Oral TabletPSN91fa852c-b43d-4a55-983b-74aa6827125d4
855344warfarin sodium 7.5 MG Oral TabletPSN91fa852c-b43d-4a55-983b-74aa6827125d4
855290warfarin sodium 1 MG Oral Tablet [Coumadin]SBD91fa852c-b43d-4a55-983b-74aa6827125d4
855298warfarin sodium 10 MG Oral Tablet [Coumadin]SBD91fa852c-b43d-4a55-983b-74aa6827125d4
855304warfarin sodium 2 MG Oral Tablet [Coumadin]SBD91fa852c-b43d-4a55-983b-74aa6827125d4
855314warfarin sodium 2.5 MG Oral Tablet [Coumadin]SBD91fa852c-b43d-4a55-983b-74aa6827125d4
855320warfarin sodium 3 MG Oral Tablet [Coumadin]SBD91fa852c-b43d-4a55-983b-74aa6827125d4
855326warfarin sodium 4 MG Oral Tablet [Coumadin]SBD91fa852c-b43d-4a55-983b-74aa6827125d4
855334warfarin sodium 5 MG Oral Tablet [Coumadin]SBD91fa852c-b43d-4a55-983b-74aa6827125d4
855340warfarin sodium 6 MG Oral Tablet [Coumadin]SBD91fa852c-b43d-4a55-983b-74aa6827125d4
855346warfarin sodium 7.5 MG Oral Tablet [Coumadin]SBD91fa852c-b43d-4a55-983b-74aa6827125d4
855288warfarin sodium 1 MG Oral TabletSCD91fa852c-b43d-4a55-983b-74aa6827125d4
855296warfarin sodium 10 MG Oral TabletSCD91fa852c-b43d-4a55-983b-74aa6827125d4
855302warfarin sodium 2 MG Oral TabletSCD91fa852c-b43d-4a55-983b-74aa6827125d4
855312warfarin sodium 2.5 MG Oral TabletSCD91fa852c-b43d-4a55-983b-74aa6827125d4
855318warfarin sodium 3 MG Oral TabletSCD91fa852c-b43d-4a55-983b-74aa6827125d4
855324warfarin sodium 4 MG Oral TabletSCD91fa852c-b43d-4a55-983b-74aa6827125d4
855332warfarin sodium 5 MG Oral TabletSCD91fa852c-b43d-4a55-983b-74aa6827125d4
855338warfarin sodium 6 MG Oral TabletSCD91fa852c-b43d-4a55-983b-74aa6827125d4
855344warfarin sodium 7.5 MG Oral TabletSCD91fa852c-b43d-4a55-983b-74aa6827125d4
855290Coumadin 1 MG Oral TabletSY91fa852c-b43d-4a55-983b-74aa6827125d4
855298Coumadin 10 MG Oral TabletSY91fa852c-b43d-4a55-983b-74aa6827125d4
855304Coumadin 2 MG Oral TabletSY91fa852c-b43d-4a55-983b-74aa6827125d4
855314Coumadin 2.5 MG Oral TabletSY91fa852c-b43d-4a55-983b-74aa6827125d4
855320Coumadin 3 MG Oral TabletSY91fa852c-b43d-4a55-983b-74aa6827125d4
855326Coumadin 4 MG Oral TabletSY91fa852c-b43d-4a55-983b-74aa6827125d4
855334Coumadin 5 MG Oral TabletSY91fa852c-b43d-4a55-983b-74aa6827125d4
855340Coumadin 6 MG Oral TabletSY91fa852c-b43d-4a55-983b-74aa6827125d4
855346Coumadin 7.5 MG Oral TabletSY91fa852c-b43d-4a55-983b-74aa6827125d4
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