FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
76282-331
11-digit product format
762820331
Labeler code
76282
Product ID
76282-331_45e85c4e-ae91-4cf3-bd98-1d5b5aecc7c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin
Dosage form
TABLET
Route
ORAL
Labeler
Exelan Pharmaceuticals Inc.
Application
ANDA090935
Marketing category
ANDA
Marketing start
2015-04-08
Substance
WARFARIN SODIUM
Active strength
4 mg/1
Pharmacologic classes
Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Warfarin Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WARFARIN SODIUM4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6153CWM0CL
Rxcui855288, 855296, 855302, 855312, 855318, 855324, 855332, 855338, 855344

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
abcfe2f4-1eca-fdc3-341b-b8134a1aec1fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-331-01Warfarin Sodium100 in 1 BOTTLETABLET10013
76282-331-10Warfarin Sodium1000 in 1 BOTTLETABLET100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-331-01EA - Each76282-33100e05a65-d554-4b6c-9f88-24516e68df9112015-05-05
76282-331-10EA - Each76282-331e16bd73e-56c6-4dc4-bec1-e897a2f9d82d12015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WARFARIN SODIUMACTIVE INGREDIENT6153CWM0CLWARFARIN SODIUM (WARFARIN) TABLET [EXELAN PHARMACEUTICALS INC.]5
WARFARINACTIVE MOIETY5Q7ZVV76EIWARFARIN SODIUM (WARFARIN) TABLET [EXELAN PHARMACEUTICALS INC.]5
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BWARFARIN SODIUM (WARFARIN) TABLET [EXELAN PHARMACEUTICALS INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GWARFARIN SODIUM (WARFARIN) TABLET [EXELAN PHARMACEUTICALS INC.]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKWARFARIN SODIUM (WARFARIN) TABLET [EXELAN PHARMACEUTICALS INC.]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAWARFARIN SODIUM (WARFARIN) TABLET [EXELAN PHARMACEUTICALS INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8WARFARIN SODIUM (WARFARIN) TABLET [EXELAN PHARMACEUTICALS INC.]5
HYDROXYPROPYL CELLULOSE (TYPE E)INACTIVE INGREDIENT66O7AQV0RTWARFARIN SODIUM (WARFARIN) TABLET [EXELAN PHARMACEUTICALS INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XWARFARIN SODIUM (WARFARIN) TABLET [EXELAN PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WARFARIN SODIUM (WARFARIN) TABLET [EXELAN PHARMACEUTICALS INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJWARFARIN SODIUM (WARFARIN) TABLET [EXELAN PHARMACEUTICALS INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-331WARFARIN SODIUM (WARFARIN) TABLET [EXELAN PHARMACEUTICALS INC.]13Current NDC, Legacy NDC, 2 package rows20200923_c0cc4511-e656-4b6d-96cd-e02e76173b9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855288warfarin sodium 1 MG Oral TabletPSNc0cc4511-e656-4b6d-96cd-e02e76173b9d13
855296warfarin sodium 10 MG Oral TabletPSNc0cc4511-e656-4b6d-96cd-e02e76173b9d13
855302warfarin sodium 2 MG Oral TabletPSNc0cc4511-e656-4b6d-96cd-e02e76173b9d13
855312warfarin sodium 2.5 MG Oral TabletPSNc0cc4511-e656-4b6d-96cd-e02e76173b9d13
855318warfarin sodium 3 MG Oral TabletPSNc0cc4511-e656-4b6d-96cd-e02e76173b9d13
855324warfarin sodium 4 MG Oral TabletPSNc0cc4511-e656-4b6d-96cd-e02e76173b9d13
855332warfarin sodium 5 MG Oral TabletPSNc0cc4511-e656-4b6d-96cd-e02e76173b9d13
855338warfarin sodium 6 MG Oral TabletPSNc0cc4511-e656-4b6d-96cd-e02e76173b9d13
855344warfarin sodium 7.5 MG Oral TabletPSNc0cc4511-e656-4b6d-96cd-e02e76173b9d13
855288warfarin sodium 1 MG Oral TabletSCDc0cc4511-e656-4b6d-96cd-e02e76173b9d13
855296warfarin sodium 10 MG Oral TabletSCDc0cc4511-e656-4b6d-96cd-e02e76173b9d13
855302warfarin sodium 2 MG Oral TabletSCDc0cc4511-e656-4b6d-96cd-e02e76173b9d13
855312warfarin sodium 2.5 MG Oral TabletSCDc0cc4511-e656-4b6d-96cd-e02e76173b9d13
855318warfarin sodium 3 MG Oral TabletSCDc0cc4511-e656-4b6d-96cd-e02e76173b9d13
855324warfarin sodium 4 MG Oral TabletSCDc0cc4511-e656-4b6d-96cd-e02e76173b9d13
855332warfarin sodium 5 MG Oral TabletSCDc0cc4511-e656-4b6d-96cd-e02e76173b9d13
855338warfarin sodium 6 MG Oral TabletSCDc0cc4511-e656-4b6d-96cd-e02e76173b9d13
855344warfarin sodium 7.5 MG Oral TabletSCDc0cc4511-e656-4b6d-96cd-e02e76173b9d13
855288warfarin sodium 1 MG Oral TabletPSNa2f6c9f7-87dc-7428-e053-2995a90a1de64
855296warfarin sodium 10 MG Oral TabletPSNa2f6c9f7-87dc-7428-e053-2995a90a1de64
855302warfarin sodium 2 MG Oral TabletPSNa2f6c9f7-87dc-7428-e053-2995a90a1de64
855312warfarin sodium 2.5 MG Oral TabletPSNa2f6c9f7-87dc-7428-e053-2995a90a1de64
855318warfarin sodium 3 MG Oral TabletPSNa2f6c9f7-87dc-7428-e053-2995a90a1de64
855324warfarin sodium 4 MG Oral TabletPSNa2f6c9f7-87dc-7428-e053-2995a90a1de64
855332warfarin sodium 5 MG Oral TabletPSNa2f6c9f7-87dc-7428-e053-2995a90a1de64
855338warfarin sodium 6 MG Oral TabletPSNa2f6c9f7-87dc-7428-e053-2995a90a1de64
855344warfarin sodium 7.5 MG Oral TabletPSNa2f6c9f7-87dc-7428-e053-2995a90a1de64
855288warfarin sodium 1 MG Oral TabletSCDa2f6c9f7-87dc-7428-e053-2995a90a1de64
855296warfarin sodium 10 MG Oral TabletSCDa2f6c9f7-87dc-7428-e053-2995a90a1de64
855302warfarin sodium 2 MG Oral TabletSCDa2f6c9f7-87dc-7428-e053-2995a90a1de64
855312warfarin sodium 2.5 MG Oral TabletSCDa2f6c9f7-87dc-7428-e053-2995a90a1de64
855318warfarin sodium 3 MG Oral TabletSCDa2f6c9f7-87dc-7428-e053-2995a90a1de64
855324warfarin sodium 4 MG Oral TabletSCDa2f6c9f7-87dc-7428-e053-2995a90a1de64
855332warfarin sodium 5 MG Oral TabletSCDa2f6c9f7-87dc-7428-e053-2995a90a1de64
855338warfarin sodium 6 MG Oral TabletSCDa2f6c9f7-87dc-7428-e053-2995a90a1de64
855344warfarin sodium 7.5 MG Oral TabletSCDa2f6c9f7-87dc-7428-e053-2995a90a1de64
855288warfarin sodium 1 MG Oral TabletPSN4f276251-49b7-438f-9c47-f1cdfc47e5193
855296warfarin sodium 10 MG Oral TabletPSN4f276251-49b7-438f-9c47-f1cdfc47e5193
855302warfarin sodium 2 MG Oral TabletPSN4f276251-49b7-438f-9c47-f1cdfc47e5193
855312warfarin sodium 2.5 MG Oral TabletPSN4f276251-49b7-438f-9c47-f1cdfc47e5193
855318warfarin sodium 3 MG Oral TabletPSN4f276251-49b7-438f-9c47-f1cdfc47e5193
855324warfarin sodium 4 MG Oral TabletPSN4f276251-49b7-438f-9c47-f1cdfc47e5193
855332warfarin sodium 5 MG Oral TabletPSN4f276251-49b7-438f-9c47-f1cdfc47e5193
855344warfarin sodium 7.5 MG Oral TabletPSN4f276251-49b7-438f-9c47-f1cdfc47e5193
855288warfarin sodium 1 MG Oral TabletSCD4f276251-49b7-438f-9c47-f1cdfc47e5193
855296warfarin sodium 10 MG Oral TabletSCD4f276251-49b7-438f-9c47-f1cdfc47e5193
855302warfarin sodium 2 MG Oral TabletSCD4f276251-49b7-438f-9c47-f1cdfc47e5193
855312warfarin sodium 2.5 MG Oral TabletSCD4f276251-49b7-438f-9c47-f1cdfc47e5193
855318warfarin sodium 3 MG Oral TabletSCD4f276251-49b7-438f-9c47-f1cdfc47e5193
855324warfarin sodium 4 MG Oral TabletSCD4f276251-49b7-438f-9c47-f1cdfc47e5193
855332warfarin sodium 5 MG Oral TabletSCD4f276251-49b7-438f-9c47-f1cdfc47e5193
855344warfarin sodium 7.5 MG Oral TabletSCD4f276251-49b7-438f-9c47-f1cdfc47e5193
855324warfarin sodium 4 MG Oral TabletPSNab9a7543-0ad2-75b5-e053-2995a90a1f4e1
855324warfarin sodium 4 MG Oral TabletSCDab9a7543-0ad2-75b5-e053-2995a90a1f4e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-331-0176282033101100 TABLET in 1 BOTTLE (76282-331-01) 100 tablet2015-04-080000-00-00NoNoCurrent
76282-331-10762820331101000 TABLET in 1 BOTTLE (76282-331-10) 1000 tablet2015-04-080000-00-00NoNoCurrent