FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
43353-021
11-digit product format
433530021
Labeler code
43353
Product ID
43353-021_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
2 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 SODIUM2 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
43353-021-30Warfarin Sodium30 in 1 BOTTLETABLET303
43353-021-35Warfarin Sodium35 in 1 BOTTLETABLET353
43353-021-40Warfarin Sodium40 in 1 BOTTLETABLET403
43353-021-45Warfarin Sodium45 in 1 BOTTLETABLET453
43353-021-50Warfarin Sodium50 in 1 BOTTLETABLET503
43353-021-53Warfarin Sodium60 in 1 BOTTLETABLET603
43353-021-55Warfarin Sodium75 in 1 BOTTLETABLET753
43353-021-60Warfarin Sodium90 in 1 BOTTLETABLET903
43353-021-61Warfarin Sodium70 in 1 BOTTLETABLET703
43353-021-70Warfarin Sodium120 in 1 BOTTLETABLET1203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-021-30EA - Each43353-021b2b1c5db-c86f-4382-932b-fc6ed32bf72312016-07-19
43353-021-35EA - Each43353-0210a350aa4-90e2-4c73-910b-6a4b8817948c12016-07-19
43353-021-40EA - Each43353-0210d9cb002-562a-4545-a59e-8d3bd6a3bd8212016-07-19
43353-021-45EA - Each43353-0213beccf0d-f972-4815-b0c6-7b90ccc64dda12016-07-19
43353-021-50EA - Each43353-021a2592b03-5b61-43f9-9b87-eb32e92c960f12016-07-19
43353-021-53EA - Each43353-0216dbbfad8-85f0-49fa-bfa3-cac9564448bb12016-07-19
43353-021-55EA - Each43353-0211699bd6d-5a27-42a2-b9d6-9f7a54dad84412016-07-19
43353-021-60EA - Each43353-021ec4be788-c433-4c35-84c0-4a731588c3a912016-07-19
43353-021-61EA - Each43353-0210429288d-2f2a-4ee6-a4e9-13e8eb85897412016-07-19
43353-021-70EA - Each43353-021851ba4d7-0bda-446a-848c-123640f8971d12016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-021WARFARIN SODIUM (WARFARIN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 10 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
43353-021-304335300213030 TABLET in 1 BOTTLE (43353-021-30) 30 tablet2015-04-250000-00-00NoNoCurrent
43353-021-354335300213535 TABLET in 1 BOTTLE (43353-021-35) 35 tablet2015-04-250000-00-00NoNoCurrent
43353-021-404335300214040 TABLET in 1 BOTTLE (43353-021-40) 40 tablet2015-04-250000-00-00NoNoCurrent
43353-021-454335300214545 TABLET in 1 BOTTLE (43353-021-45) 45 tablet2015-04-250000-00-00NoNoCurrent
43353-021-504335300215050 TABLET in 1 BOTTLE (43353-021-50) 50 tablet2015-05-150000-00-00NoNoCurrent
43353-021-534335300215360 TABLET in 1 BOTTLE (43353-021-53) 60 tablet2015-04-260000-00-00NoNoCurrent
43353-021-554335300215575 TABLET in 1 BOTTLE (43353-021-55) 75 tablet2015-05-220000-00-00NoNoCurrent
43353-021-604335300216090 TABLET in 1 BOTTLE (43353-021-60) 90 tablet2015-04-260000-00-00NoNoCurrent
43353-021-614335300216170 TABLET in 1 BOTTLE (43353-021-61) 70 tablet2015-08-060000-00-00NoNoCurrent
43353-021-7043353002170120 TABLET in 1 BOTTLE (43353-021-70) 120 tablet2015-05-220000-00-00NoNoCurrent