FDA.reportPublic FDA data

warfarin sodium

Product NDC
58517-360
11-digit product format
585170360
Labeler code
58517
Product ID
58517-360_f7a32c82-ba7f-4c77-b3b2-f080afee9c6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
warfarin sodium
Dosage form
TABLET
Route
ORAL
Labeler
New Horizon Rx Group, LLC
Application
ANDA040663
Marketing category
ANDA
Marketing start
2013-08-25
Marketing end
0000-00-00
Substance
WARFARIN SODIUM
Active strength
5 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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct58517-360IInactivated by FDA2026-07-31
excluded packagepackage58517-36058517-360-30IInactivated by FDA2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040663-001WARFARIN SODIUMWARFARIN SODIUM1MGTABLET / ORALAB2006-05-30
A040663-002WARFARIN SODIUMWARFARIN SODIUM2MGTABLET / ORALAB2006-05-30
A040663-003WARFARIN SODIUMWARFARIN SODIUM2.5MGTABLET / ORALAB2006-05-30
A040663-004WARFARIN SODIUMWARFARIN SODIUM3MGTABLET / ORALAB2006-05-30
A040663-005WARFARIN SODIUMWARFARIN SODIUM4MGTABLET / ORALAB2006-05-30
A040663-006WARFARIN SODIUMWARFARIN SODIUM5MGTABLET / ORALAB2006-05-30
A040663-007WARFARIN SODIUMWARFARIN SODIUM6MGTABLET / ORALAB2006-05-30
A040663-008WARFARIN SODIUMWARFARIN SODIUM7.5MGTABLET / ORALAB2006-05-30
A040663-009WARFARIN SODIUMWARFARIN SODIUM10MGTABLET / ORALAB2006-05-30

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A040663-001AB
A040663-002AB
A040663-003AB
A040663-004AB
A040663-005AB
A040663-006AB
A040663-007AB
A040663-008AB
A040663-009AB

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
58517-360-302019-11-27C16284748780-19855e2a2-45a8-60a7-e053-dbdaa90a05bdWarfarin Sodium Tablets, USP for oral use These highlights do not include all the information needed to use warfarin sodium safely and effectively. See full prescribing information for warfarin sodium. warfarin sodium (warfarin sodium) TABLET for ORAL use. Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58517-360-30warfarin sodium30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58517-360-30EA - Each58517-3608b19d7dc-3caf-4825-b6c2-75a6bb22df7b12013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WARFARIN SODIUMACTIVE INGREDIENT6153CWM0CLWARFARIN SODIUM TABLET [NEW HORIZON RX GROUP, LLC]2
WARFARINACTIVE MOIETY5Q7ZVV76EIWARFARIN SODIUM TABLET [NEW HORIZON RX GROUP, LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8WARFARIN SODIUM TABLET [NEW HORIZON RX GROUP, LLC]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PWARFARIN SODIUM TABLET [NEW HORIZON RX GROUP, LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XWARFARIN SODIUM TABLET [NEW HORIZON RX GROUP, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WARFARIN SODIUM TABLET [NEW HORIZON RX GROUP, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJWARFARIN SODIUM TABLET [NEW HORIZON RX GROUP, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58517-360WARFARIN SODIUM TABLET [NEW HORIZON RX GROUP, LLC]2Legacy NDC, 1 package rows20131228_553c6cb0-3ba9-4006-95e5-9c397016253a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855332warfarin sodium 5 MG Oral TabletPSN553c6cb0-3ba9-4006-95e5-9c397016253a2
855332warfarin sodium 5 MG Oral TabletSCD553c6cb0-3ba9-4006-95e5-9c397016253a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
58517-360-305851703603030 in 1 BOTTLEHistorical