Warfarin Sodium

Product NDC
0093-1712
11-digit product format
000931712
Labeler code
0093
Product ID
0093-1712_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
2015-10-19
Substance
WARFARIN SODIUM
Active strength
1 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 SODIUM1 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
0093-1712-01Warfarin Sodium100 in 1 BOTTLETABLET10020
0093-1712-10Warfarin Sodium1000 in 1 BOTTLETABLET100020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-1712-01EA - Each0093-1712f7233cc7-2860-4d76-b8e6-116ce1406d3212015-11-12
0093-1712-10EA - Each0093-171280391ae3-44d4-4b7b-adad-adefc0c6da7612015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WARFARIN SODIUMACTIVE INGREDIENT6153CWM0CLWARFARIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]1
WARFARINACTIVE MOIETY5Q7ZVV76EIWARFARIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933WARFARIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UWARFARIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48WARFARIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GWARFARIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]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 [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 [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
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WARFARIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]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
0093-1712WARFARIN 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
855288warfarin sodium 1 MG Oral TabletPSNa1860448-d4ef-40f2-b096-056429ca3aea102
855288warfarin sodium 1 MG Oral TabletSCDa1860448-d4ef-40f2-b096-056429ca3aea102
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
855288warfarin sodium 1 MG Oral TabletPSN724b0061-f42a-4008-a078-09c800ee978517
855288warfarin sodium 1 MG Oral TabletSCD724b0061-f42a-4008-a078-09c800ee978517
855288warfarin sodium 1 MG Oral TabletPSNf32d3578-0c90-567c-e053-2a95a90a23b84
855288warfarin sodium 1 MG Oral TabletSCDf32d3578-0c90-567c-e053-2a95a90a23b84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-1712-0100093171201100 TABLET in 1 BOTTLE (0093-1712-01) 100 tablet2015-10-190000-00-00NoNoCurrent
0093-1712-10000931712101000 TABLET in 1 BOTTLE (0093-1712-10) 1000 tablet2015-10-280000-00-00NoNoCurrent