FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
71610-575
11-digit product format
716100575
Labeler code
71610
Product ID
71610-575_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
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
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
71610-575-15Warfarin Sodium15 in 1 BOTTLETABLET151
71610-575-20Warfarin Sodium20 in 1 BOTTLETABLET201
71610-575-25Warfarin Sodium25 in 1 BOTTLETABLET251
71610-575-30Warfarin Sodium30 in 1 BOTTLETABLET301
71610-575-35Warfarin Sodium35 in 1 BOTTLETABLET351
71610-575-38Warfarin Sodium55 in 1 BOTTLETABLET551
71610-575-40Warfarin Sodium40 in 1 BOTTLETABLET401
71610-575-45Warfarin Sodium45 in 1 BOTTLETABLET451
71610-575-50Warfarin Sodium50 in 1 BOTTLETABLET501
71610-575-53Warfarin Sodium60 in 1 BOTTLETABLET601
71610-575-55Warfarin Sodium75 in 1 BOTTLETABLET751
71610-575-60Warfarin Sodium90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-575-15EA - Each71610-575cdbafd39-63ce-4b17-bc9b-3ea998d248ab12021-09-07
71610-575-20EA - Each71610-5753ae28612-3872-4f22-a72d-425753c7dcf712021-09-07
71610-575-25EA - Each71610-575abb9dab2-0562-4451-8a42-f92ccf47bc5512021-09-07
71610-575-30EA - Each71610-57536711f85-3cc2-437c-842e-4081e8327c1112021-09-07
71610-575-35EA - Each71610-575e24e2c83-d15e-4848-ba0b-945a8d77216912021-09-07
71610-575-38EA - Each71610-575ef836a60-db57-4f70-928f-c99140633a5812021-09-07
71610-575-40EA - Each71610-57531817fab-ab18-4fdb-b10c-82959b5b682212021-09-07
71610-575-45EA - Each71610-575d23de3ca-013a-400f-8daf-169baa1d68ad12021-09-07
71610-575-50EA - Each71610-575486fa998-13dd-44ed-a8f0-3a222d5564a512021-09-07
71610-575-53EA - Each71610-5754b5d24fe-0abc-4ec9-a640-5b0c606fc4cf12021-09-07
71610-575-55EA - Each71610-57555aa4f74-28e7-4aef-a359-39aadda7f95f12021-09-07
71610-575-60EA - Each71610-575766bcd52-9f50-4187-8155-2b4d312ca47912021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-575WARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 12 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
71610-575-157161005751515 TABLET in 1 BOTTLE (71610-575-15) 15 tablet2021-06-280000-00-00NoNoCurrent
71610-575-207161005752020 TABLET in 1 BOTTLE (71610-575-20) 20 tablet2021-06-280000-00-00NoNoCurrent
71610-575-257161005752525 TABLET in 1 BOTTLE (71610-575-25) 25 tablet2021-06-280000-00-00NoNoCurrent
71610-575-307161005753030 TABLET in 1 BOTTLE (71610-575-30) 30 tablet2021-06-280000-00-00NoNoCurrent
71610-575-357161005753535 TABLET in 1 BOTTLE (71610-575-35) 35 tablet2021-06-280000-00-00NoNoCurrent
71610-575-387161005753855 TABLET in 1 BOTTLE (71610-575-38) 55 tablet2021-07-290000-00-00NoNoCurrent
71610-575-407161005754040 TABLET in 1 BOTTLE (71610-575-40) 40 tablet2021-06-280000-00-00NoNoCurrent
71610-575-457161005754545 TABLET in 1 BOTTLE (71610-575-45) 45 tablet2021-06-280000-00-00NoNoCurrent
71610-575-507161005755050 TABLET in 1 BOTTLE (71610-575-50) 50 tablet2021-06-280000-00-00NoNoCurrent
71610-575-537161005755360 TABLET in 1 BOTTLE (71610-575-53) 60 tablet2021-06-280000-00-00NoNoCurrent
71610-575-557161005755575 TABLET in 1 BOTTLE (71610-575-55) 75 tablet2021-06-280000-00-00NoNoCurrent
71610-575-607161005756090 TABLET in 1 BOTTLE (71610-575-60) 90 tablet2021-06-280000-00-00NoNoCurrent