FDA.reportPublic FDA data

NDC 70518-2383-03 - 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
70518-2383
Requested NDC
70518-2383-03
Package NDCs from labels
70518-2383-1, 70518-2383-0, 70518-2383-2, 70518-2383-3, 70518-2383-4, 70518-2383-03
Manufacturer
REMEDYREPACK INC.
Effective date
2026-06-29
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.2026-06-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2383-0Warfarin Sodium100 in 1 BOXTABLET10010
70518-2383-1Warfarin Sodium1 in 1 POUCHTABLET110
70518-2383-2Warfarin Sodium30 in 1 BOTTLE, PLASTICTABLET3010
70518-2383-3Warfarin Sodium30 in 1 BLISTER PACKTABLET3010

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
application number: ANDA202202
rxcui: 855312
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMCardinal Health 107, LLC7c4deb97-9966-4c8e-9ba6-bb260b71e1302026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855312
unii: 6153CWM0CL
Warfarin SodiumWARFARINCoupler LLC598e5e2e-9264-8371-e063-6394a90aaf182026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202202
rxcui: 855318
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.bd6ea120-5d1c-4815-94f2-81e28dc6b7a92026-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
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
application number: ANDA202202
rxcui: 855338
unii: 6153CWM0CL
Warfarin SodiumWARFARINREMEDYREPACK INC.51e98fb6-ba76-497e-95d8-fe895ef0b7ed2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202202
rxcui: 855312
unii: 6153CWM0CL
Warfarin SodiumWARFARINREMEDYREPACK INC.a4cf3107-5646-4b91-8aae-94548e4409ef2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202202
ndc (package): 70518-2383-3
ndc (package): 70518-2383-2
ndc (package): 70518-2383-4
ndc (package): 70518-2383-1
ndc (package): 70518-2383-0
ndc (product): 70518-2383
ndc11 (package): 70518238303
rxcui: 855288
spl id: 5564b633-eaed-d561-e063-6394a90aa6ab
spl set id: a4cf3107-5646-4b91-8aae-94548e4409ef
unii: 6153CWM0CL
Warfarin SodiumWARFARINREMEDYREPACK INC.2fb8b8d5-f643-4069-8e47-5eae31a8fbc82026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202202
rxcui: 855344
unii: 6153CWM0CL
Warfarin SodiumWARFARINREMEDYREPACK INC.884cdbf6-0a52-4126-8e14-b0d7c9367e332026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202202
rxcui: 855318
unii: 6153CWM0CL
Warfarin SodiumWARFARINREMEDYREPACK INC.8eddba53-19c4-411b-b0d4-cb2f948ba1252026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202202
rxcui: 855296
unii: 6153CWM0CL
Warfarin SodiumWARFARINREMEDYREPACK INC.2cbcc99d-9107-4d39-a1e9-e19305de8b5d2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202202
rxcui: 855302
unii: 6153CWM0CL
Warfarin SodiumWARFARINREMEDYREPACK INC.8ee94789-72d2-4c42-9dbd-0501e9767d972026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202202
rxcui: 855332
unii: 6153CWM0CL
Warfarin SodiumWARFARINREMEDYREPACK INC.545ec40d-2db1-4581-b3ec-ce195e5f54002026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202202
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
rxcui: 855288
unii: 6153CWM0CL

Reported adverse events (FAERS/openFDA)#

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