FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
63187-674
11-digit product format
631870674
Labeler code
63187
Product ID
63187-674_55160086-9335-4d4b-bfc9-bb77270e0bb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040616
Marketing category
ANDA
Marketing start
2015-04-07
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
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 SODIUM5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6153CWM0CL
Rxcui855332

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
63187-674-00Warfarin Sodium100 in 1 BOTTLETABLET1006
63187-674-10Warfarin Sodium10 in 1 BAGTABLET106
63187-674-30Warfarin Sodium30 in 1 BOTTLETABLET306
63187-674-60Warfarin Sodium60 in 1 BOTTLETABLET606
63187-674-90Warfarin Sodium90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-674-10EA - Each63187-674af68ed56-5e83-41dc-aa4e-da86ee84fb2c12018-02-20
63187-674-60EA - Each63187-674b4e27106-9cde-4dfc-b622-2c6287691c3d12016-11-08
63187-674-90EA - Each63187-67446d5658c-6adf-40ec-a741-124691f3ece612016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-674WARFARIN SODIUM TABLET [PROFICIENT RX LP]6Current NDC, Legacy NDC, 5 package rows20220430_388bfa49-f4f7-412a-80ff-d09442489e2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855332warfarin sodium 5 MG Oral TabletPSN388bfa49-f4f7-412a-80ff-d09442489e2b6
855332warfarin sodium 5 MG Oral TabletSCD388bfa49-f4f7-412a-80ff-d09442489e2b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-674-0063187067400100 TABLET in 1 BOTTLE (63187-674-00) 100 tablet2017-04-030000-00-00NoNoCurrent
63187-674-106318706741010 TABLET in 1 BAG (63187-674-10) 10 tablet2018-01-010000-00-00NoNoCurrent
63187-674-306318706743030 TABLET in 1 BOTTLE (63187-674-30) 30 tablet2015-04-150000-00-00NoNoCurrent
63187-674-606318706746060 TABLET in 1 BOTTLE (63187-674-60) 60 tablet2015-04-070000-00-00NoNoCurrent
63187-674-906318706749090 TABLET in 1 BOTTLE (63187-674-90) 90 tablet2017-04-030000-00-00NoNoCurrent