FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
51655-620
11-digit product format
516550620
Labeler code
51655
Product ID
51655-620_4b81033f-d891-feb5-e063-6394a90a7538
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA040616
Marketing category
ANDA
Marketing start
2023-01-03
Substance
WARFARIN SODIUM
Active strength
1 mg/1
Pharmacologic classes
Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Warfarin Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WARFARIN SODIUM1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6153CWM0CL
Rxcui855288

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
abcfe2f4-1eca-fdc3-341b-b8134a1aec1fProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-620-522026-01-29C16284748780-149896155-a98c-586f-e063-e6dba90add90These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets, for oral use Initial U.S. Approval: 1954

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-620-52Warfarin Sodium30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-620WARFARIN SODIUM TABLET [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 1 package rows20230321_f32d3578-0c90-567c-e053-2a95a90a23b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855288warfarin sodium 1 MG Oral TabletPSNf32d3578-0c90-567c-e053-2a95a90a23b84
855288warfarin sodium 1 MG Oral TabletSCDf32d3578-0c90-567c-e053-2a95a90a23b84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-620-525165506205230 TABLET in 1 BOTTLE, PLASTIC (51655-620-52) 30 tablet2023-01-03NoNoCurrent