FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
53217-018
11-digit product format
532170018
Labeler code
53217
Product ID
53217-018_569f166d-b427-4409-9418-8432052de580
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA202202
Marketing category
ANDA
Marketing start
2010-08-16
Marketing end
0000-00-00
Substance
WARFARIN SODIUM
Active strength
8 mg/1
Pharmacologic classes
Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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
53217-018-072020-01-31C16284748780-19d75b9d0-cd69-f424-e053-dadaa90a57ceThese 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) TABLET for ORAL use. Initial U.S. Approval: 1954
53217-018-142020-01-31C16284748780-19d75b9d0-cd69-f424-e053-dadaa90a57ceThese 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) TABLET for ORAL use. Initial U.S. Approval: 1954
53217-018-302020-01-31C16284748780-19d75b9d0-cd69-f424-e053-dadaa90a57ceThese 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) TABLET for ORAL use. Initial U.S. Approval: 1954
53217-018-602020-01-31C16284748780-19d75b9d0-cd69-f424-e053-dadaa90a57ceThese 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) TABLET for ORAL use. Initial U.S. Approval: 1954
53217-018-902020-01-31C16284748780-19d75b9d0-cd69-f424-e053-dadaa90a57ceThese 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) TABLET for ORAL use. Initial U.S. Approval: 1954

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-018-07Warfarin Sodium7 in 1 BOTTLE, PLASTICTABLET71
53217-018-14Warfarin Sodium14 in 1 BOTTLE, PLASTICTABLET141
53217-018-30Warfarin Sodium30 in 1 BOTTLE, PLASTICTABLET301
53217-018-60Warfarin Sodium60 in 1 BOTTLE, PLASTICTABLET601
53217-018-90Warfarin Sodium90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-018-30EA - Each53217-01861899422-5e34-4fd8-a054-610ab5be92eb12015-10-02
53217-018-60EA - Each53217-01867ed7203-b7f9-406b-b072-b6f013ffa0c812015-10-02
53217-018-90EA - Each53217-0188f7f593e-85bf-49a3-94f3-328a193d658812015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WARFARIN SODIUMACTIVE INGREDIENT6153CWM0CLWARFARIN SODIUM (WARFARIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1
WARFARINACTIVE MOIETY5Q7ZVV76EIWARFARIN SODIUM (WARFARIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GWARFARIN SODIUM (WARFARIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8WARFARIN SODIUM (WARFARIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1
HYDROXYPROPYL CELLULOSE (TYPE E)INACTIVE INGREDIENT66O7AQV0RTWARFARIN SODIUM (WARFARIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XWARFARIN SODIUM (WARFARIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WARFARIN SODIUM (WARFARIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJWARFARIN SODIUM (WARFARIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-018WARFARIN SODIUM (WARFARIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 5 package rows20140214_e11e4522-4b34-4170-af51-7b602924c746.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855344warfarin sodium 7.5 MG Oral TabletPSNe11e4522-4b34-4170-af51-7b602924c7461
855344warfarin sodium 7.5 MG Oral TabletSCDe11e4522-4b34-4170-af51-7b602924c7461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-018-07532170018077 in 1 BOTTLE, PLASTICHistorical
53217-018-145321700181414 in 1 BOTTLE, PLASTICHistorical
53217-018-305321700183030 in 1 BOTTLE, PLASTICHistorical
53217-018-605321700186060 in 1 BOTTLE, PLASTICHistorical
53217-018-905321700189090 in 1 BOTTLE, PLASTICHistorical