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 4 of 4 · 79 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Warfarin SodiumWARFARINPreferred Pharmaceuticals Inc.ac117f50-8e67-4203-8d97-e53dd0687c202025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855312
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMA-S Medication Solutions53a6947e-ef3f-403b-9ccc-1740ae5efad02024-12-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855302
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMAmerican Health Packagingab047628-67d0-4a64-8d77-36b054969b442024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040301
rxcui: 855302
rxcui: 855332
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMAmerican Health Packagingfeaa5f6f-9753-4f37-ab81-04c9c6b45e6a2024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040301
ndc (package): 68084-027-01
ndc (package): 68084-027-11
ndc (product): 68084-027
ndc11 (package): 68084002711
rxcui: 855312
spl id: 23a944e6-45c2-fba1-e063-6394a90a31a8
spl set id: feaa5f6f-9753-4f37-ab81-04c9c6b45e6a
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMA-S Medication Solutions5a7d347b-391e-4e9b-a691-1962c7da4fc72024-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855296
unii: 6153CWM0CL
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
Warfarin SodiumWARFARINBryant Ranch Prepack7fdfd870-e72d-4d88-b6d9-1d711b66d09f2024-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855296
unii: 6153CWM0CL
Warfarin SodiumWARFARINBryant Ranch Prepack3dd9f8ce-75e0-426a-9d22-6af7742a0ca72023-12-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855302
unii: 6153CWM0CL
Warfarin SodiumWARFARINBryant Ranch Prepackaddaac3d-6fb5-484f-8535-04eb410d2bf02023-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855312
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMA-S Medication Solutions35bf53df-994b-4c32-8bdb-9227e8e195c62023-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855332
unii: 6153CWM0CL
Warfarin SodiumWARFARINBryant Ranch Prepackc41b7c23-8053-428a-ac1d-8395e714c2f12023-04-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855318
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMProficient Rx LP388bfa49-f4f7-412a-80ff-d09442489e2b2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855332
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMAphena Pharma Solutions - Tennessee, LLCe73d37f8-8a28-4d93-9529-fd1e2c84228a2021-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040301
rxcui: 855324
rxcui: 855312
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMAphena Pharma Solutions - Tennessee, LLC2c8f47c6-a180-4ad8-b962-04069d2270cb2021-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040301
rxcui: 855302
rxcui: 855332
unii: 6153CWM0CL
Warfarin SodiumWARFARINAphena Pharma Solutions - Tennessee, LLC52b3c2f6-b5ca-44ae-bdcc-552d5191034f2021-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855302
unii: 6153CWM0CL
Warfarin SodiumWARFARINAphena Pharma Solutions - Tennessee, LLCa98916a5-cdb2-4251-bdea-0245c763b2f12020-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855324
rxcui: 855312
unii: 6153CWM0CL
Warfarin SodiumWARFARINExelan Pharmaceuticals Inc.c0cc4511-e656-4b6d-96cd-e02e76173b9d2020-09-09Boxed 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 SodiumWARFARINAphena Pharma Solutions - Tennessee, LLC91f24482-d4cb-4a09-a97e-64f6e49071ee2020-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855332
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMProficient Rx LP73048ed9-242f-4f86-a8db-9c7547daa01d2020-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855296
rxcui: 855312
unii: 6153CWM0CL

Reported adverse events (FAERS/openFDA)#

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