FDA.reportPublic FDA data

NDC 62584-994-11 - 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
62584-994
Requested NDC
62584-994-11
Package NDCs from labels
62584-994-11, 62584-994-01
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-10-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Warfarin Sodium - Cardinal Health 107, LLCCardinal Health 107, LLC2026-10-06HUMAN PRESCRIPTION DRUG LABEL
Warfarin Sodium - American Health PackagingAmerican Health Packaging2024-10-04HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62584-994-01Warfarin Sodium100 in 1 BOX, UNIT-DOSETABLET10011
62584-994-11Warfarin Sodium1 in 1 BLISTER PACKTABLET111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62584-994WARFARIN SODIUM TABLET [AMERICAN HEALTH PACKAGING]11Current NDC, Legacy NDC, 2 package rows20241006_ab047628-67d0-4a64-8d77-36b054969b44.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62584-994-01EA - Each62584-994979ae26b-cee8-46c5-b131-dcec14a7a1f612012-07-24
62584-994-11EA - Each62584-99474bbf701-3ce2-4a74-8a88-61ef31176b0312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Warfarin SodiumACTIVE INGREDIENT6153CWM0CLWARFARIN SODIUM TABLET [AMERICAN HEALTH PACKAGING]3
WarfarinACTIVE MOIETY5Q7ZVV76EIWARFARIN SODIUM TABLET [AMERICAN HEALTH PACKAGING]3
Aluminum OxideINACTIVE INGREDIENTLMI26O6933WARFARIN SODIUM TABLET [AMERICAN HEALTH PACKAGING]3
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKWARFARIN SODIUM TABLET [AMERICAN HEALTH PACKAGING]3
Barium OxideINACTIVE INGREDIENT77603K202BWARFARIN SODIUM TABLET [AMERICAN HEALTH PACKAGING]3
D&C Red No. 6INACTIVE INGREDIENT481744AI4OWARFARIN SODIUM TABLET [AMERICAN HEALTH PACKAGING]3
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GWARFARIN SODIUM TABLET [AMERICAN HEALTH PACKAGING]3
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKWARFARIN SODIUM TABLET [AMERICAN HEALTH PACKAGING]3
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAWARFARIN SODIUM TABLET [AMERICAN HEALTH PACKAGING]3
magnesium stearateINACTIVE INGREDIENT70097M6I30WARFARIN SODIUM TABLET [AMERICAN HEALTH PACKAGING]3
starch, cornINACTIVE INGREDIENTO8232NY3SJWARFARIN SODIUM TABLET [AMERICAN HEALTH PACKAGING]3

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 1 of 4 · 80 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Warfarin SodiumWARFARINCoupler LLC5a5b5e3a-6556-a542-e063-6294a90a6d3f2026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855312
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMCardinal Health 107, LLC7c4deb97-9966-4c8e-9ba6-bb260b71e1302026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040301
rxcui: 855312
unii: 6153CWM0CL
Warfarin SodiumWARFARINCoupler LLC598e5e2e-9264-8371-e063-6394a90aaf182026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855318
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.bd6ea120-5d1c-4815-94f2-81e28dc6b7a92026-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040301
rxcui: 855318
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.724b0061-f42a-4008-a078-09c800ee97852026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855288
unii: 6153CWM0CL
Warfarin SodiumWARFARINREMEDYREPACK INC.d7fb4290-ed37-4ed3-ae51-c400191961dc2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855338
unii: 6153CWM0CL
Warfarin SodiumWARFARINREMEDYREPACK INC.51e98fb6-ba76-497e-95d8-fe895ef0b7ed2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855312
unii: 6153CWM0CL
Warfarin SodiumWARFARINREMEDYREPACK INC.a4cf3107-5646-4b91-8aae-94548e4409ef2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855288
unii: 6153CWM0CL
Warfarin SodiumWARFARINREMEDYREPACK INC.2fb8b8d5-f643-4069-8e47-5eae31a8fbc82026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855344
unii: 6153CWM0CL
Warfarin SodiumWARFARINREMEDYREPACK INC.884cdbf6-0a52-4126-8e14-b0d7c9367e332026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855318
unii: 6153CWM0CL
Warfarin SodiumWARFARINREMEDYREPACK INC.8eddba53-19c4-411b-b0d4-cb2f948ba1252026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855296
unii: 6153CWM0CL
Warfarin SodiumWARFARINREMEDYREPACK INC.2cbcc99d-9107-4d39-a1e9-e19305de8b5d2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855302
unii: 6153CWM0CL
Warfarin SodiumWARFARINREMEDYREPACK INC.8ee94789-72d2-4c42-9dbd-0501e9767d972026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855332
unii: 6153CWM0CL
Warfarin SodiumWARFARINREMEDYREPACK INC.545ec40d-2db1-4581-b3ec-ce195e5f54002026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855324
unii: 6153CWM0CL
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

Reported adverse events (FAERS/openFDA)#

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