FDA.reportPublic FDA data

Warfarin Sodium

Product NDC
0093-1721
11-digit product format
000931721
Labeler code
0093
Product ID
0093-1721_b8c33971-54b3-4971-bf7f-1bec66999a29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Warfarin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA040616
Marketing category
ANDA
Marketing start
2015-04-07
Substance
WARFARIN SODIUM
Active strength
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WARFARIN SODIUM5 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
0093-1721-01Warfarin Sodium100 in 1 BOTTLETABLET10020
0093-1721-10Warfarin Sodium1000 in 1 BOTTLETABLET100020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-1721-01EA - Each0093-1721f229dc49-f431-4326-9281-652eab63cd7712015-05-05
0093-1721-10EA - Each0093-172120a1e755-1f3b-4eeb-b3eb-5b4c9d19544012015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WARFARIN SODIUMACTIVE INGREDIENT6153CWM0CLWARFARIN SODIUM TABLET [DIRECTRX]1
WARFARIN SODIUMACTIVE INGREDIENT6153CWM0CLWARFARIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]1
WARFARINACTIVE MOIETY5Q7ZVV76EIWARFARIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]1
WARFARINACTIVE MOIETY5Q7ZVV76EIWARFARIN SODIUM TABLET [DIRECTRX]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933WARFARIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933WARFARIN SODIUM TABLET [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UWARFARIN SODIUM TABLET [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UWARFARIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48WARFARIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48WARFARIN SODIUM TABLET [DIRECTRX]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GWARFARIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GWARFARIN SODIUM TABLET [DIRECTRX]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDWARFARIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKWARFARIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAWARFARIN SODIUM TABLET [DIRECTRX]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAWARFARIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MWARFARIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8WARFARIN SODIUM TABLET [DIRECTRX]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8WARFARIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]1
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LWARFARIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XWARFARIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XWARFARIN SODIUM TABLET [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WARFARIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WARFARIN SODIUM TABLET [DIRECTRX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4WARFARIN SODIUM TABLET [DIRECTRX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4WARFARIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-1721WARFARIN SODIUM TABLET [TEVA PHARMACEUTICALS USA, INC.]18Current NDC, Legacy NDC, 2 package rows20221014_0cbce382-9c88-4f58-ae0f-532a841e8f95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855332warfarin sodium 5 MG Oral TabletPSNe7f78a33-71eb-4aac-ba9d-70f75136fab0103
855332warfarin sodium 5 MG Oral TabletSCDe7f78a33-71eb-4aac-ba9d-70f75136fab0103
855332warfarin sodium 5 MG Oral TabletPSN44077bb7-6007-4c15-bbcd-a7a02ac081ce22
855332warfarin sodium 5 MG Oral TabletSCD44077bb7-6007-4c15-bbcd-a7a02ac081ce22
855288warfarin sodium 1 MG Oral TabletPSN0cbce382-9c88-4f58-ae0f-532a841e8f9520
855296warfarin sodium 10 MG Oral TabletPSN0cbce382-9c88-4f58-ae0f-532a841e8f9520
855302warfarin sodium 2 MG Oral TabletPSN0cbce382-9c88-4f58-ae0f-532a841e8f9520
855312warfarin sodium 2.5 MG Oral TabletPSN0cbce382-9c88-4f58-ae0f-532a841e8f9520
855318warfarin sodium 3 MG Oral TabletPSN0cbce382-9c88-4f58-ae0f-532a841e8f9520
855324warfarin sodium 4 MG Oral TabletPSN0cbce382-9c88-4f58-ae0f-532a841e8f9520
855332warfarin sodium 5 MG Oral TabletPSN0cbce382-9c88-4f58-ae0f-532a841e8f9520
855338warfarin sodium 6 MG Oral TabletPSN0cbce382-9c88-4f58-ae0f-532a841e8f9520
855344warfarin sodium 7.5 MG Oral TabletPSN0cbce382-9c88-4f58-ae0f-532a841e8f9520
855288warfarin sodium 1 MG Oral TabletSCD0cbce382-9c88-4f58-ae0f-532a841e8f9520
855296warfarin sodium 10 MG Oral TabletSCD0cbce382-9c88-4f58-ae0f-532a841e8f9520
855302warfarin sodium 2 MG Oral TabletSCD0cbce382-9c88-4f58-ae0f-532a841e8f9520
855312warfarin sodium 2.5 MG Oral TabletSCD0cbce382-9c88-4f58-ae0f-532a841e8f9520
855318warfarin sodium 3 MG Oral TabletSCD0cbce382-9c88-4f58-ae0f-532a841e8f9520
855324warfarin sodium 4 MG Oral TabletSCD0cbce382-9c88-4f58-ae0f-532a841e8f9520
855332warfarin sodium 5 MG Oral TabletSCD0cbce382-9c88-4f58-ae0f-532a841e8f9520
855338warfarin sodium 6 MG Oral TabletSCD0cbce382-9c88-4f58-ae0f-532a841e8f9520
855344warfarin sodium 7.5 MG Oral TabletSCD0cbce382-9c88-4f58-ae0f-532a841e8f9520
855332warfarin sodium 5 MG Oral TabletPSNf5fb1a5f-0dda-4f47-8683-ea63ac88a69d18
855332warfarin sodium 5 MG Oral TabletSCDf5fb1a5f-0dda-4f47-8683-ea63ac88a69d18
855332warfarin sodium 5 MG Oral TabletPSN21255cd5-3c2e-4574-9620-9347d14256b314
855332warfarin sodium 5 MG Oral TabletSCD21255cd5-3c2e-4574-9620-9347d14256b314
855332warfarin sodium 5 MG Oral TabletPSN388bfa49-f4f7-412a-80ff-d09442489e2b6
855332warfarin sodium 5 MG Oral TabletSCD388bfa49-f4f7-412a-80ff-d09442489e2b6
855332warfarin sodium 5 MG Oral TabletPSN35bf53df-994b-4c32-8bdb-9227e8e195c64
855332warfarin sodium 5 MG Oral TabletPSNf32dd451-3f7a-815b-e053-2995a90a528f4
855332warfarin sodium 5 MG Oral TabletSCD35bf53df-994b-4c32-8bdb-9227e8e195c64
855332warfarin sodium 5 MG Oral TabletSCDf32dd451-3f7a-815b-e053-2995a90a528f4
855302warfarin sodium 2 MG Oral TabletPSN2384f45e-ad8e-4367-b99d-a2c670f99d021
855332warfarin sodium 5 MG Oral TabletPSNbf21781b-d4d5-456d-a5bc-d48bd2da61ce1
855332warfarin sodium 5 MG Oral TabletPSN2384f45e-ad8e-4367-b99d-a2c670f99d021
855302warfarin sodium 2 MG Oral TabletSCD2384f45e-ad8e-4367-b99d-a2c670f99d021
855332warfarin sodium 5 MG Oral TabletSCD2384f45e-ad8e-4367-b99d-a2c670f99d021
855332warfarin sodium 5 MG Oral TabletSCDbf21781b-d4d5-456d-a5bc-d48bd2da61ce1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-1721-0100093172101100 TABLET in 1 BOTTLE (0093-1721-01) 100 tablet2015-04-150000-00-00NoNoCurrent
0093-1721-10000931721101000 TABLET in 1 BOTTLE (0093-1721-10) 1000 tablet2015-04-070000-00-00NoNoCurrent