FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
65162-768
11-digit product format
651620768
Labeler code
65162
Product ID
65162-768_55689f10-365b-449e-b224-52363f835529
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA202202
Marketing category
ANDA
Marketing start
2010-08-16
Substance
WARFARIN SODIUM
Active strength
7.5 mg/1
Pharmacologic classes
Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
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 SODIUM7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6153CWM0CL
Rxcui855288, 855296, 855302, 855312, 855318, 855324, 855332, 855338, 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
65162-768-10Warfarin Sodium100 in 1 BOTTLETABLET10019
65162-768-11Warfarin Sodium1000 in 1 BOTTLETABLET100019
65162-768-50Warfarin Sodium500 in 1 BOTTLETABLET50019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-768-10EA - Each65162-768877694d2-3e47-46ed-b2d6-422643601fb412013-06-04
65162-768-11EA - Each65162-76823069fb7-80fb-4206-b375-987bde60cce512013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WARFARIN SODIUMACTIVE INGREDIENT6153CWM0CLWARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC]7
WARFARINACTIVE MOIETY5Q7ZVV76EIWARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC]7
D&C RED NO. 6INACTIVE INGREDIENT481744AI4OWARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GWARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDWARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKWARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAWARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC]7
HYDROXYPROPYL CELLULOSE (TYPE E)INACTIVE INGREDIENT66O7AQV0RTWARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XWARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJWARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS, LLC]7
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
65162-768WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS LLC]19Current NDC, Legacy NDC, 3 package rows20241031_558b7a0d-5490-4c1b-802e-3ab3f1efe760.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855288warfarin sodium 1 MG Oral TabletPSN541c9a70-adaf-4ef3-94ba-ad4e70dfa05751
855296warfarin sodium 10 MG Oral TabletPSN541c9a70-adaf-4ef3-94ba-ad4e70dfa05751
855302warfarin sodium 2 MG Oral TabletPSN541c9a70-adaf-4ef3-94ba-ad4e70dfa05751
855312warfarin sodium 2.5 MG Oral TabletPSN541c9a70-adaf-4ef3-94ba-ad4e70dfa05751
855318warfarin sodium 3 MG Oral TabletPSN541c9a70-adaf-4ef3-94ba-ad4e70dfa05751
855324warfarin sodium 4 MG Oral TabletPSN541c9a70-adaf-4ef3-94ba-ad4e70dfa05751
855332warfarin sodium 5 MG Oral TabletPSN541c9a70-adaf-4ef3-94ba-ad4e70dfa05751
855338warfarin sodium 6 MG Oral TabletPSN541c9a70-adaf-4ef3-94ba-ad4e70dfa05751
855344warfarin sodium 7.5 MG Oral TabletPSN541c9a70-adaf-4ef3-94ba-ad4e70dfa05751
855288warfarin sodium 1 MG Oral TabletSCD541c9a70-adaf-4ef3-94ba-ad4e70dfa05751
855296warfarin sodium 10 MG Oral TabletSCD541c9a70-adaf-4ef3-94ba-ad4e70dfa05751
855302warfarin sodium 2 MG Oral TabletSCD541c9a70-adaf-4ef3-94ba-ad4e70dfa05751
855312warfarin sodium 2.5 MG Oral TabletSCD541c9a70-adaf-4ef3-94ba-ad4e70dfa05751
855318warfarin sodium 3 MG Oral TabletSCD541c9a70-adaf-4ef3-94ba-ad4e70dfa05751
855324warfarin sodium 4 MG Oral TabletSCD541c9a70-adaf-4ef3-94ba-ad4e70dfa05751
855332warfarin sodium 5 MG Oral TabletSCD541c9a70-adaf-4ef3-94ba-ad4e70dfa05751
855338warfarin sodium 6 MG Oral TabletSCD541c9a70-adaf-4ef3-94ba-ad4e70dfa05751
855344warfarin sodium 7.5 MG Oral TabletSCD541c9a70-adaf-4ef3-94ba-ad4e70dfa05751
855344warfarin sodium 7.5 MG Oral TabletPSNe11e4522-4b34-4170-af51-7b602924c7461
855344warfarin sodium 7.5 MG Oral TabletPSN2f2119e8-f583-ba16-e063-6394a90a13a21
855344warfarin sodium 7.5 MG Oral TabletSCDe11e4522-4b34-4170-af51-7b602924c7461
855344warfarin sodium 7.5 MG Oral TabletSCD2f2119e8-f583-ba16-e063-6394a90a13a21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-768-1065162076810100 TABLET in 1 BOTTLE (65162-768-10) 100 tablet2010-08-160000-00-00NoNoCurrent
65162-768-11651620768111000 TABLET in 1 BOTTLE (65162-768-11) 1000 tablet2010-08-160000-00-00NoNoCurrent
65162-768-5065162076850500 TABLET in 1 BOTTLE (65162-768-50) 500 tablet2010-08-160000-00-00NoNoCurrent