FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
71610-574
11-digit product format
716100574
Labeler code
71610
Product ID
71610-574_1997af85-ab19-433b-9467-e360932e3edf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA040301
Marketing category
ANDA
Marketing start
1999-07-15
Substance
WARFARIN SODIUM
Active strength
2 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 SODIUM2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6153CWM0CL
Rxcui855302, 855332

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
71610-574-30Warfarin Sodium30 in 1 BOTTLETABLET301
71610-574-35Warfarin Sodium35 in 1 BOTTLETABLET351
71610-574-40Warfarin Sodium40 in 1 BOTTLETABLET401
71610-574-45Warfarin Sodium45 in 1 BOTTLETABLET451
71610-574-53Warfarin Sodium60 in 1 BOTTLETABLET601
71610-574-60Warfarin Sodium90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-574-30EA - Each71610-5740aa2e78c-8cb9-4650-bf8d-e592b81c1b2712021-09-07
71610-574-35EA - Each71610-574136b2209-b3b8-4617-bad6-6f9f8dd8926012021-09-07
71610-574-40EA - Each71610-574001250d5-3646-481e-94bd-f49f8d088b0712021-09-07
71610-574-45EA - Each71610-574cefb4d15-8f69-4c7f-9a1e-ae4e10c6673412021-09-07
71610-574-53EA - Each71610-57499f05521-9fee-44a7-aa97-72d2e7a56d3512021-09-07
71610-574-60EA - Each71610-574abc15322-087c-4025-89ee-48b9c225be1212021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-574WARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 6 package rows20210803_2c8f47c6-a180-4ad8-b962-04069d2270cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855302warfarin sodium 2 MG Oral TabletPSN2c8f47c6-a180-4ad8-b962-04069d2270cb1
855332warfarin sodium 5 MG Oral TabletPSN2c8f47c6-a180-4ad8-b962-04069d2270cb1
855302warfarin sodium 2 MG Oral TabletSCD2c8f47c6-a180-4ad8-b962-04069d2270cb1
855332warfarin sodium 5 MG Oral TabletSCD2c8f47c6-a180-4ad8-b962-04069d2270cb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-574-307161005743030 TABLET in 1 BOTTLE (71610-574-30) 30 tablet2021-06-250000-00-00NoNoCurrent
71610-574-357161005743535 TABLET in 1 BOTTLE (71610-574-35) 35 tablet2021-06-250000-00-00NoNoCurrent
71610-574-407161005744040 TABLET in 1 BOTTLE (71610-574-40) 40 tablet2021-06-250000-00-00NoNoCurrent
71610-574-457161005744545 TABLET in 1 BOTTLE (71610-574-45) 45 tablet2021-06-250000-00-00NoNoCurrent
71610-574-537161005745360 TABLET in 1 BOTTLE (71610-574-53) 60 tablet2021-06-250000-00-00NoNoCurrent
71610-574-607161005746090 TABLET in 1 BOTTLE (71610-574-60) 90 tablet2021-06-250000-00-00NoNoCurrent