FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
43353-049
11-digit product format
433530049
Labeler code
43353
Product ID
43353-049_b2821ecc-6d75-4ea4-b57c-78ad508fe7e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA040301
Marketing category
ANDA
Marketing start
1999-07-15
Marketing end
0000-00-00
Substance
WARFARIN SODIUM
Active strength
4 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
43353-049-302020-01-31C16284748780-19d75b9d1-2b11-f424-e053-dadaa90a57ceWarfarin Sodium Tablets, USP Crystalline
43353-049-602020-01-31C16284748780-19d75b9d1-2b11-f424-e053-dadaa90a57ceWarfarin Sodium Tablets, USP Crystalline

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-049-30Warfarin Sodium30 in 1 BOTTLE, PLASTICTABLET302
43353-049-60Warfarin Sodium90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-049-30EA - Each43353-0498108f15b-e1ed-4cf0-8663-4de849aafc4b12014-06-03
43353-049-60EA - Each43353-049c05531d5-26bb-4ac6-87d1-a96efb09ec3212014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WARFARIN SODIUMACTIVE INGREDIENT6153CWM0CLWARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
WARFARINACTIVE MOIETY5Q7ZVV76EIWARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
Anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKWARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
D&C RED NO. 6INACTIVE INGREDIENT481744AI4OWARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GWARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDWARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKWARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAWARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
magnesium stearateINACTIVE INGREDIENT70097M6I30WARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJWARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-049WARFARIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 2 package rows20140507_c437507c-d308-4aac-aa5e-a54972c7fa95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855288warfarin sodium 1 MG Oral TabletPSNc437507c-d308-4aac-aa5e-a54972c7fa952
855296warfarin sodium 10 MG Oral TabletPSNc437507c-d308-4aac-aa5e-a54972c7fa952
855312warfarin sodium 2.5 MG Oral TabletPSNc437507c-d308-4aac-aa5e-a54972c7fa952
855318warfarin sodium 3 MG Oral TabletPSNc437507c-d308-4aac-aa5e-a54972c7fa952
855324warfarin sodium 4 MG Oral TabletPSNc437507c-d308-4aac-aa5e-a54972c7fa952
855332warfarin sodium 5 MG Oral TabletPSNc437507c-d308-4aac-aa5e-a54972c7fa952
855338warfarin sodium 6 MG Oral TabletPSNc437507c-d308-4aac-aa5e-a54972c7fa952
855344warfarin sodium 7.5 MG Oral TabletPSNc437507c-d308-4aac-aa5e-a54972c7fa952
855288warfarin sodium 1 MG Oral TabletSCDc437507c-d308-4aac-aa5e-a54972c7fa952
855296warfarin sodium 10 MG Oral TabletSCDc437507c-d308-4aac-aa5e-a54972c7fa952
855312warfarin sodium 2.5 MG Oral TabletSCDc437507c-d308-4aac-aa5e-a54972c7fa952
855318warfarin sodium 3 MG Oral TabletSCDc437507c-d308-4aac-aa5e-a54972c7fa952
855324warfarin sodium 4 MG Oral TabletSCDc437507c-d308-4aac-aa5e-a54972c7fa952
855332warfarin sodium 5 MG Oral TabletSCDc437507c-d308-4aac-aa5e-a54972c7fa952
855338warfarin sodium 6 MG Oral TabletSCDc437507c-d308-4aac-aa5e-a54972c7fa952
855344warfarin sodium 7.5 MG Oral TabletSCDc437507c-d308-4aac-aa5e-a54972c7fa952

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-049-304335300493030 in 1 BOTTLE, PLASTICHistorical
43353-049-604335300496090 in 1 BOTTLE, PLASTICHistorical