FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
53808-0985
11-digit product format
538080985
Labeler code
53808
Product ID
53808-0985_6505df44-aafe-42d9-ac5d-a517238f55ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
WARFARIN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA040301
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
WARFARIN SODIUM
Active strength
1 mg/1
Pharmacologic classes
Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
53808-0985-12019-10-21C16284748780-1956f9ecf-d680-621f-e053-dbdaa90a74adWarfarin Sodium Tablets, USP Crystalline

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0985-1Warfarin Sodium30 in 1 BLISTER PACKTABLET301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WARFARIN SODIUMACTIVE INGREDIENT6153CWM0CLWARFARIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
WARFARINACTIVE MOIETY5Q7ZVV76EIWARFARIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKWARFARIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
D&C RED NO. 6INACTIVE INGREDIENT481744AI4OWARFARIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GWARFARIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKWARFARIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAWARFARIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WARFARIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJWARFARIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0985WARFARIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100611_801e4da1-5459-47d2-b67b-009f0a3247cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855288warfarin sodium 1 MG Oral TabletPSN801e4da1-5459-47d2-b67b-009f0a3247cc1
855296warfarin sodium 10 MG Oral TabletPSN801e4da1-5459-47d2-b67b-009f0a3247cc1
855302warfarin sodium 2 MG Oral TabletPSN801e4da1-5459-47d2-b67b-009f0a3247cc1
855312warfarin sodium 2.5 MG Oral TabletPSN801e4da1-5459-47d2-b67b-009f0a3247cc1
855318warfarin sodium 3 MG Oral TabletPSN801e4da1-5459-47d2-b67b-009f0a3247cc1
855332warfarin sodium 5 MG Oral TabletPSN801e4da1-5459-47d2-b67b-009f0a3247cc1
855344warfarin sodium 7.5 MG Oral TabletPSN801e4da1-5459-47d2-b67b-009f0a3247cc1
855288warfarin sodium 1 MG Oral TabletSCD801e4da1-5459-47d2-b67b-009f0a3247cc1
855296warfarin sodium 10 MG Oral TabletSCD801e4da1-5459-47d2-b67b-009f0a3247cc1
855302warfarin sodium 2 MG Oral TabletSCD801e4da1-5459-47d2-b67b-009f0a3247cc1
855312warfarin sodium 2.5 MG Oral TabletSCD801e4da1-5459-47d2-b67b-009f0a3247cc1
855318warfarin sodium 3 MG Oral TabletSCD801e4da1-5459-47d2-b67b-009f0a3247cc1
855332warfarin sodium 5 MG Oral TabletSCD801e4da1-5459-47d2-b67b-009f0a3247cc1
855344warfarin sodium 7.5 MG Oral TabletSCD801e4da1-5459-47d2-b67b-009f0a3247cc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0985-15380809850130 in 1 BLISTER PACKHistorical