FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
71610-462
11-digit product format
716100462
Labeler code
71610
Product ID
71610-462_7499368e-bc27-4934-833c-66da6ebf845c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA090935
Marketing category
ANDA
Marketing start
2011-05-25
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

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
71610-462-30Warfarin Sodium30 in 1 BOTTLETABLET302
71610-462-35Warfarin Sodium35 in 1 BOTTLETABLET352
71610-462-40Warfarin Sodium40 in 1 BOTTLETABLET402
71610-462-45Warfarin Sodium45 in 1 BOTTLETABLET452
71610-462-53Warfarin Sodium60 in 1 BOTTLETABLET602
71610-462-60Warfarin Sodium90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-462-35EA - Each71610-462e9c94a28-1d23-47d1-a4f9-19e9694865a412021-03-02
71610-462-40EA - Each71610-462624535a3-fb06-4a47-9bed-29e713d9914812021-03-02
71610-462-45EA - Each71610-4625ea1c0df-f720-4aab-b30b-7aff933b49d212021-03-02
71610-462-53EA - Each71610-462b796dba5-e932-4870-b6b4-4d9871ae090f12021-03-02
71610-462-60EA - Each71610-46244af2d7e-9575-427d-a617-a819abb8840f12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-462WARFARIN SODIUM (WARFARIN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 6 package rows20210129_52b3c2f6-b5ca-44ae-bdcc-552d5191034f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855302warfarin sodium 2 MG Oral TabletPSN52b3c2f6-b5ca-44ae-bdcc-552d5191034f2
855302warfarin sodium 2 MG Oral TabletSCD52b3c2f6-b5ca-44ae-bdcc-552d5191034f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-462-307161004623030 TABLET in 1 BOTTLE (71610-462-30) 30 tablet2020-09-090000-00-00NoNoCurrent
71610-462-357161004623535 TABLET in 1 BOTTLE (71610-462-35) 35 tablet2020-12-210000-00-00NoNoCurrent
71610-462-407161004624040 TABLET in 1 BOTTLE (71610-462-40) 40 tablet2020-12-210000-00-00NoNoCurrent
71610-462-457161004624545 TABLET in 1 BOTTLE (71610-462-45) 45 tablet2020-12-210000-00-00NoNoCurrent
71610-462-537161004625360 TABLET in 1 BOTTLE (71610-462-53) 60 tablet2020-12-210000-00-00NoNoCurrent
71610-462-607161004626090 TABLET in 1 BOTTLE (71610-462-60) 90 tablet2020-12-210000-00-00NoNoCurrent