FDA.reportPublic FDA data

NDC 70518-2382-01 - 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
70518-2382
Requested NDC
70518-2382-01
Package NDCs from labels
70518-2382-1, 70518-2382-0, 70518-2382-2, 70518-2382-3, 70518-2382-4, 70518-2382-5, 70518-2382-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-06-25
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.2026-06-25HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-03-09These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets (crystalline), for oral use Initial U.S. Approval: 1954
2023-03-09These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets (crystalline), for oral use Initial U.S. Approval: 1954
2023-03-09These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets (crystalline), for oral use Initial U.S. Approval: 1954
2023-01-30These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets (crystalline), for oral use Initial U.S. Approval: 1954
2023-01-30These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets (crystalline), for oral use Initial U.S. Approval: 1954
2023-01-30These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets (crystalline), for oral use Initial U.S. Approval: 1954

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2382-0Warfarin Sodium100 in 1 BOXTABLET10012
70518-2382-1Warfarin Sodium1 in 1 POUCHTABLET112
70518-2382-2Warfarin Sodium90 in 1 BOTTLE, PLASTICTABLET9012
70518-2382-3Warfarin Sodium30 in 1 BOTTLE, PLASTICTABLET3012
70518-2382-4Warfarin Sodium30 in 1 BLISTER PACKTABLET3012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2382WARFARIN SODIUM (WARFARIN) TABLET [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 5 package rows20250315_8ee94789-72d2-4c42-9dbd-0501e9767d97.zip

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
rxcui: 855302
unii: 6153CWM0CL
Warfarin SodiumWARFARINAmneal Pharmaceuticals LLC558b7a0d-5490-4c1b-802e-3ab3f1efe7602026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202202
ndc (product): 65162-766
rxcui: 855324
rxcui: 855296
rxcui: 855344
rxcui: 855302
rxcui: 855288
rxcui: 855338
rxcui: 855318
rxcui: 855312
rxcui: 855332
spl id: caa13d7d-5a78-412c-8e5e-e03a51164e96
spl set id: 558b7a0d-5490-4c1b-802e-3ab3f1efe760
unii: 6153CWM0CL
Warfarin SodiumWARFARINCoupler LLC52bacf1e-9ba8-7eca-e063-6394a90ab60b2026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202202
rxcui: 855288
unii: 6153CWM0CL
Warfarin SodiumWARFARINCoupler LLC5256c518-31bf-f73b-e063-6394a90a71da2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202202
rxcui: 855302
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.6b227c9e-02e9-4ec9-8b11-3ab6fe5093e52026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855312
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.72d3ea20-27e4-4368-a666-a9b76530dbb92026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855332
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.61ab23a7-bc67-4777-854a-bf43c788a69a2026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855344
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.7b3b6f89-1feb-4939-a95b-7ad0707f4d762026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855296
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.73b8e5ab-86f8-44f8-b290-346acb81c9ae2026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
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.