FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
68788-8402
11-digit product format
687888402
Labeler code
68788
Product ID
68788-8402_3687ceaf-725c-4aea-9708-af212aacf43e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA202202
Marketing category
ANDA
Marketing start
2023-03-21
Substance
WARFARIN SODIUM
Active strength
2.5 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 SODIUM2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6153CWM0CL
Rxcui855312

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
68788-8402-1Warfarin Sodium100 in 1 BOTTLETABLET1002
68788-8402-3Warfarin Sodium30 in 1 BOTTLETABLET302
68788-8402-6Warfarin Sodium60 in 1 BOTTLETABLET602
68788-8402-9Warfarin Sodium90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8402-1EA - Each68788-84024ee8c9ae-fc18-4b38-93e6-47965de9a06912023-06-06
68788-8402-3EA - Each68788-8402bd6c278a-03b7-463e-b04d-133df45b5ae012023-06-06
68788-8402-6EA - Each68788-8402a2f31c38-d5a7-4983-a841-487b773f8c6612023-06-06
68788-8402-9EA - Each68788-840218a9f48a-3174-46ea-8ea2-ba2b4b2dae7c12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8402WARFARIN SODIUM (WARFARIN) TABLET [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 4 package rows20250119_ac117f50-8e67-4203-8d97-e53dd0687c20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855312warfarin sodium 2.5 MG Oral TabletPSNac117f50-8e67-4203-8d97-e53dd0687c202
855312warfarin sodium 2.5 MG Oral TabletSCDac117f50-8e67-4203-8d97-e53dd0687c202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8402-168788840201100 TABLET in 1 BOTTLE (68788-8402-1) 100 tablet2023-03-21NoNoCurrent
68788-8402-36878884020330 TABLET in 1 BOTTLE (68788-8402-3) 30 tablet2023-03-21NoNoCurrent
68788-8402-66878884020660 TABLET in 1 BOTTLE (68788-8402-6) 60 tablet2023-03-21NoNoCurrent
68788-8402-96878884020990 TABLET in 1 BOTTLE (68788-8402-9) 90 tablet2023-03-21NoNoCurrent