FDA.reportPublic FDA data

NDC 51672-4035-01 - Warfarin Sodium

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
51672-4035
Requested NDC
51672-4035-01
Package NDCs from labels
51672-4035-1, 51672-4035-3, 51672-4035-0, 51672-4035-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-04-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Warfarin Sodium - REMEDYREPACK INC.REMEDYREPACK INC.2026-04-27HUMAN PRESCRIPTION DRUG LABEL
Warfarin Sodium - Bryant Ranch PrepackBryant Ranch Prepack2025-08-19HUMAN PRESCRIPTION DRUG LABEL
Warfarin SodiumSun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd.2025-06-10HUMAN PRESCRIPTION DRUG LABEL
Warfarin Sodium - Med-Health Pharma, LLCMed-Health Pharma, LLC2012-01-20HUMAN PRESCRIPTION DRUG LABEL
Warfarin Sodium - State of Florida DOH Central PharmacyState of Florida DOH Central Pharmacy2010-06-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4035-0Warfarin Sodium10 in 1 CARTONTABLET1014
51672-4035-0Warfarin Sodium10 in 1 BLISTER PACKTABLET1014
51672-4035-1Warfarin Sodium100 in 1 BOTTLETABLET10014
51672-4035-3Warfarin Sodium1000 in 1 BOTTLETABLET100014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4035WARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]13Current NDC, Legacy NDC, 4 package rows20231222_8ad881e0-ca41-42ad-9d7d-eb85b3a30af0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4035-1EA - Each51672-40356913202d-98ae-46c3-ba38-c24fbc8c015d12012-07-24
51672-4035-3EA - Each51672-40357cb6580a-5970-429b-9993-e3378adcf4f512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WARFARIN SODIUMACTIVE INGREDIENT6153CWM0CLWARFARIN SODIUM TABLET [BRYANT RANCH PREPACK]1001
WARFARINACTIVE MOIETY5Q7ZVV76EIWARFARIN SODIUM TABLET [BRYANT RANCH PREPACK]1001
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKWARFARIN SODIUM TABLET [BRYANT RANCH PREPACK]1001
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WARFARIN SODIUM TABLET [BRYANT RANCH PREPACK]1001
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJWARFARIN SODIUM TABLET [BRYANT RANCH PREPACK]1001
Warfarin SodiumACTIVE INGREDIENT6153CWM0CLWARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
WarfarinACTIVE MOIETY5Q7ZVV76EIWARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
Aluminum OxideINACTIVE INGREDIENTLMI26O6933WARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKWARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
Barium OxideINACTIVE INGREDIENT77603K202BWARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
D&C Red No. 6INACTIVE INGREDIENT481744AI4OWARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GWARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDWARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKWARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAWARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
magnesium stearateINACTIVE INGREDIENT70097M6I30WARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
starch, cornINACTIVE INGREDIENTO8232NY3SJWARFARIN SODIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
Warfarin SodiumACTIVE INGREDIENT6153CWM0CLWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
WarfarinACTIVE MOIETY5Q7ZVV76EIWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
Aluminum OxideINACTIVE INGREDIENTLMI26O6933WARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
Barium OxideINACTIVE INGREDIENT77603K202BWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
D&C Red No. 6INACTIVE INGREDIENT481744AI4OWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
magnesium stearateINACTIVE INGREDIENT70097M6I30WARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
starch, cornINACTIVE INGREDIENTO8232NY3SJWARFARIN SODIUM TABLET [MED-HEALTH PHARMA, LLC]2
WARFARIN SODIUMACTIVE INGREDIENT6153CWM0CLWARFARIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
WARFARINACTIVE MOIETY5Q7ZVV76EIWARFARIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKWARFARIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
D&C RED NO. 6INACTIVE INGREDIENT481744AI4OWARFARIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GWARFARIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKWARFARIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAWARFARIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WARFARIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJWARFARIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 9 · 165 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.f5fb1a5f-0dda-4f47-8683-ea63ac88a69d2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855332
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.1244c338-9140-425a-bf2a-9da6b4ac02872026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855302
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.d6083d68-4360-4d47-a1b2-1eb2763024bb2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855296
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.4dc2d94e-f856-47da-9d44-24773d97eb872026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855318
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.ba65ae56-ca3b-4895-9938-1dde2c3d34bf2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855324
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMA-S Medication Solutions8cd0e744-b499-4344-b1db-59f85950e1692026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040301
rxcui: 855288
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMA-S Medication Solutions991b1e3e-236e-44cf-ad61-7233f777ce672026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040301
rxcui: 855302
unii: 6153CWM0CL
GUNA-BOWELALOE - ALUMINUM OXIDE - BRYONIA ALBA ROOT - CHELIDONIUM MAJUS - CHOLECALCIFEROL - COLLINSONIA - FRANGULA ALNUS BARK - NIACIN - PANTOTHENIC ACID - POTASSIUM CARBONATE - RHUBARB - SILYBUM MARIANUM SEED - SKATOLE - SODIUM CARBONATE - STRYCHNOS NUX-VOMICA SEED - SUS SCROFA COLON - SUS SCROFA RECTUM - TARAXACUM OFFICINALE - THIAMINE -Guna spa75465821-a889-4697-b470-e9588a5232052026-06-10WarningsExact identifier
unii: LMI26O6933
Borago NicotianaBORAGO NICOTIANAUriel Pharmacy Inc.306f9eee-877b-46ee-9a36-894fa321b3d32026-06-05WarningsExact identifier
unii: LMI26O6933
Warfarin SodiumWARFARINAmneal Pharmaceuticals LLC558b7a0d-5490-4c1b-802e-3ab3f1efe7602026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855324
rxcui: 855296
rxcui: 855344
rxcui: 855302
rxcui: 855288
rxcui: 855338
rxcui: 855318
rxcui: 855312
rxcui: 855332
unii: 6153CWM0CL
Warfarin SodiumWARFARINCoupler LLC52bacf1e-9ba8-7eca-e063-6394a90ab60b2026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855288
unii: 6153CWM0CL
Warfarin SodiumWARFARINCoupler LLC5256c518-31bf-f73b-e063-6394a90a71da2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855302
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.6b227c9e-02e9-4ec9-8b11-3ab6fe5093e52026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040301
rxcui: 855312
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.72d3ea20-27e4-4368-a666-a9b76530dbb92026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040301
rxcui: 855332
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.61ab23a7-bc67-4777-854a-bf43c788a69a2026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040301
rxcui: 855344
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.7b3b6f89-1feb-4939-a95b-7ad0707f4d762026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040301
ndc (package): 70518-4636-0
ndc (package): 70518-4636-1
ndc (product): 70518-4636
rxcui: 855296
spl id: 5074a760-2338-405d-e063-6394a90aea56
spl set id: 7b3b6f89-1feb-4939-a95b-7ad0707f4d76
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.73b8e5ab-86f8-44f8-b290-346acb81c9ae2026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040301
rxcui: 855288
unii: 6153CWM0CL
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
Dynamic BrainARGENTUM NITRICUM, CUPRUM ACETICUM, GINKGO BILOBA, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, THIAMINUM HYDROCHLORICUM, CEREBRUM SUIS, AMBRA GRISEA, PICRICUM ACIDUM, AGNUS CASTUS, ALUMINA, ANACARDIUM ORIENTALE, BARYTA CARBONICA, CICUTA VIROSA, CONIUM MACULATUM, HELLEBORUS NIGER, PLUMBUM METALLICUM, SELENIUM METALLICUM, ZINCUM METALLICUMDeseret Biologicals, Inc.60a1e44b-3f91-41de-82c2-4648fb800dcd2026-03-19WarningsExact identifier
unii: LMI26O6933

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.