FDA.reportPublic FDA data

NDC 68084-027-11 - 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
68084-027
Requested NDC
68084-027-11
Package NDCs from labels
68084-027-11, 68084-027-01
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-08-25
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, LLC2026-08-25HUMAN 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
68084-027-01Warfarin Sodium100 in 1 BOX, UNIT-DOSETABLET10010
68084-027-11Warfarin Sodium1 in 1 BLISTER PACKTABLET110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-027WARFARIN SODIUM TABLET [AMERICAN HEALTH PACKAGING]10Current NDC, Legacy NDC, 2 package rows20241006_feaa5f6f-9753-4f37-ab81-04c9c6b45e6a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-027-01EA - Each68084-027f87ebc7a-b538-4f29-8699-fb099b37c23d12012-07-24
68084-027-11EA - Each68084-027d24cc9de-d0e8-4628-a974-83e68c7924ee12012-07-24

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
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKWARFARIN 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
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 2 of 4 · 79 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Warfarin SodiumWARFARIN SODIUMA-S Medication Solutions991b1e3e-236e-44cf-ad61-7233f777ce672026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040301
rxcui: 855302
unii: 6153CWM0CL
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
rxcui: 855296
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
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.3f1c3083-91d1-488c-ad07-b198fda21da62026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855338
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.748ebea5-c65b-4b5a-b237-f4eb880865fa2026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855344
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.b1bd0d02-eccb-4449-82b9-9b552835029e2026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855312
unii: 6153CWM0CL
Warfarin SodiumWARFARINAphena Pharma Solutions - Tennessee, LLC4f276251-49b7-438f-9c47-f1cdfc47e5192026-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855324
rxcui: 855296
rxcui: 855344
rxcui: 855302
rxcui: 855288
rxcui: 855318
rxcui: 855312
rxcui: 855332
unii: 6153CWM0CL
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Warfarin SodiumWARFARIN SODIUMNorthwind Health Company, LLCf32d3578-0c90-567c-e053-2a95a90a23b82026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855288
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMNorthwind Health Company, LLCf32dd451-3f7a-815b-e053-2995a90a528f2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855332
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMNorthwind Health Company, LLCf86fe457-a1b6-e54d-e053-6294a90a9bc72026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855302
unii: 6153CWM0CL
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ

Reported adverse events (FAERS/openFDA)#

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