FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
43353-030
11-digit product format
433530030
Labeler code
43353
Product ID
43353-030_49001c15-cda7-00e5-e063-6394a90a0853
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA090935
Marketing category
ANDA
Marketing start
2015-04-08
Substance
WARFARIN SODIUM
Active strength
3 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 SODIUM3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6153CWM0CL
Rxcui855288, 855296, 855302, 855312, 855318, 855324, 855332, 855344

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-030-30Warfarin Sodium30 in 1 BOTTLETABLET303
43353-030-60Warfarin Sodium90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-030-30EA - Each43353-030a52e89fd-11c6-4320-a9ea-092cc5cc6b9e12016-07-19
43353-030-60EA - Each43353-0302b3d29a4-ab06-45c1-a262-415cb839b1b212016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-030WARFARIN SODIUM (WARFARIN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 2 package rows20170711_4f276251-49b7-438f-9c47-f1cdfc47e519.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855288warfarin sodium 1 MG Oral TabletPSN4f276251-49b7-438f-9c47-f1cdfc47e5193
855296warfarin sodium 10 MG Oral TabletPSN4f276251-49b7-438f-9c47-f1cdfc47e5193
855302warfarin sodium 2 MG Oral TabletPSN4f276251-49b7-438f-9c47-f1cdfc47e5193
855312warfarin sodium 2.5 MG Oral TabletPSN4f276251-49b7-438f-9c47-f1cdfc47e5193
855318warfarin sodium 3 MG Oral TabletPSN4f276251-49b7-438f-9c47-f1cdfc47e5193
855324warfarin sodium 4 MG Oral TabletPSN4f276251-49b7-438f-9c47-f1cdfc47e5193
855332warfarin sodium 5 MG Oral TabletPSN4f276251-49b7-438f-9c47-f1cdfc47e5193
855344warfarin sodium 7.5 MG Oral TabletPSN4f276251-49b7-438f-9c47-f1cdfc47e5193
855288warfarin sodium 1 MG Oral TabletSCD4f276251-49b7-438f-9c47-f1cdfc47e5193
855296warfarin sodium 10 MG Oral TabletSCD4f276251-49b7-438f-9c47-f1cdfc47e5193
855302warfarin sodium 2 MG Oral TabletSCD4f276251-49b7-438f-9c47-f1cdfc47e5193
855312warfarin sodium 2.5 MG Oral TabletSCD4f276251-49b7-438f-9c47-f1cdfc47e5193
855318warfarin sodium 3 MG Oral TabletSCD4f276251-49b7-438f-9c47-f1cdfc47e5193
855324warfarin sodium 4 MG Oral TabletSCD4f276251-49b7-438f-9c47-f1cdfc47e5193
855332warfarin sodium 5 MG Oral TabletSCD4f276251-49b7-438f-9c47-f1cdfc47e5193
855344warfarin sodium 7.5 MG Oral TabletSCD4f276251-49b7-438f-9c47-f1cdfc47e5193

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-030-304335300303030 TABLET in 1 BOTTLE (43353-030-30) 30 tablet2015-05-040000-00-00NoNoCurrent
43353-030-604335300306090 TABLET in 1 BOTTLE (43353-030-60) 90 tablet2015-05-040000-00-00NoNoCurrent