FDA.reportPublic FDA data

NDC 54868-1259-3 - COUMADIN

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
54868-1259
Requested NDC
54868-1259-3
Package NDCs from labels
54868-1259-0, 54868-1259-1, 54868-1259-5, 54868-1259-6, 54868-1259-7, 54868-1259-3
Manufacturer
Physicians Total Care, Inc.
Effective date
2012-11-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
COUMADIN - Physicians Total Care, Inc.Physicians Total Care, Inc.2012-11-15HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
54868-1259-0These highlights do not include all the information needed to use COUMADIN safely and effectively. See full prescribing information for COUMADIN. COUMADIN (warfarin sodium) tablets, for oral use COUMADIN (warfarin sodium) for injection, for intravenous use Initial U.S. Approval: 1954
54868-1259-1These highlights do not include all the information needed to use COUMADIN safely and effectively. See full prescribing information for COUMADIN. COUMADIN (warfarin sodium) tablets, for oral use COUMADIN (warfarin sodium) for injection, for intravenous use Initial U.S. Approval: 1954
54868-1259-5These highlights do not include all the information needed to use COUMADIN safely and effectively. See full prescribing information for COUMADIN. COUMADIN (warfarin sodium) tablets, for oral use COUMADIN (warfarin sodium) for injection, for intravenous use Initial U.S. Approval: 1954
54868-1259-6These highlights do not include all the information needed to use COUMADIN safely and effectively. See full prescribing information for COUMADIN. COUMADIN (warfarin sodium) tablets, for oral use COUMADIN (warfarin sodium) for injection, for intravenous use Initial U.S. Approval: 1954
54868-1259-7These highlights do not include all the information needed to use COUMADIN safely and effectively. See full prescribing information for COUMADIN. COUMADIN (warfarin sodium) tablets, for oral use COUMADIN (warfarin sodium) for injection, for intravenous use Initial U.S. Approval: 1954

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54868-1259-0COUMADIN20 in 1 BOTTLETABLET204
54868-1259-1COUMADIN30 in 1 BOTTLETABLET304
54868-1259-5COUMADIN90 in 1 BOTTLETABLET904
54868-1259-6COUMADIN10 in 1 BOTTLETABLET104
54868-1259-7COUMADIN75 in 1 BOTTLETABLET754

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-1259COUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]45 package rows20130315_91fa852c-b43d-4a55-983b-74aa6827125d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54868-1259-0EA - Each54868-12598b5b26ca-e3c9-4a53-9f83-baf84dbee03712012-07-24
54868-1259-1EA - Each54868-125969dfcbef-4e41-4753-bc88-6df57a24f88612012-07-24
54868-1259-2EA - Each54868-1259e8125368-1d7d-42b3-9c7a-ca642e23156d12012-07-24
54868-1259-3EA - Each54868-1259bc57a6ef-4bf3-47ba-aead-6e2a9007b56512012-07-24
54868-1259-5EA - Each54868-1259507cc9a0-1715-4457-aecc-ffd1fb17b37f12012-07-24
54868-1259-6EA - Each54868-1259ccd1013f-58e0-4490-b676-db86f1fe0ac012012-07-24
54868-1259-7EA - Each54868-125961711844-8eb9-4417-afb5-4783ad02466a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
warfarin sodiumACTIVE INGREDIENT6153CWM0CLCOUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]4
warfarinACTIVE MOIETY5Q7ZVV76EICOUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]4
aluminum hydroxideINACTIVE INGREDIENT5QB0T2IUN0COUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]4
barium sulfateINACTIVE INGREDIENT25BB7EKE2ECOUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]4
D&C Red No. 6INACTIVE INGREDIENT481744AI4OCOUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]4
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GCOUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]4
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDCOUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]4
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKCOUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]4
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOACOUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]4
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8COUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]4
lactoseINACTIVE INGREDIENTJ2B2A4N98GCOUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]4
magnesium stearateINACTIVE INGREDIENT70097M6I30COUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]4
starch, tapiocaINACTIVE INGREDIENT24SC3U704ICOUMADIN (WARFARIN SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]4

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 9 of 12 · 230 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.9d5dea47-5103-21a3-e053-2995a90aee782024-05-20WarningsExact identifier
unii: J2B2A4N98G
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.9d4c4d88-43da-49dd-e053-2995a90af18d2024-03-07WarningsExact identifier
unii: J2B2A4N98G
REGULAR STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONESTRATEGIC SOURCING SERVICES LLCfe04c244-d9b8-2800-e053-6294a90aeedc2024-02-06WarningsExact identifier
unii: 5QB0T2IUN0
B05 GLUCO BALANCEADRENALINUM, ARGENTUM NITRICUM, BOS TAURUS PITUITARUM POSTERIUM, GLYCERINUM, GLYCYRRHIZA GLABRA, KALI CARBONICUM, LACTICUM ACIDUM, MAGNESIA SULPHURICA, NICCOLUM METALLICUM, PANCREATINUM, PHOSPHORICUM ACIDUM, SACCHARINUM, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SYZYGIUM JAMBOLANUM, THYROIDINUM, ZINCUM METALLICUMApex Energetics Inc.bae9ff7e-eb69-c61d-e053-2995a90a26272024-01-08WarningsExact identifier
unii: J2B2A4N98G
Warfarin SodiumWARFARINBryant Ranch Prepack7fdfd870-e72d-4d88-b6d9-1d711b66d09f2024-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855296
unii: 6153CWM0CL
Mylanta Maximum Strength Vanilla Caramel FlavorANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.ace5cae4-3a78-41c3-987d-59ce22dca2ac2024-01-01WarningsExact identifier
unii: 5QB0T2IUN0
Warfarin SodiumWARFARINBryant Ranch Prepack3dd9f8ce-75e0-426a-9d22-6af7742a0ca72023-12-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855302
unii: 6153CWM0CL
INONALUMINUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM BICARBONATESato Pharmaceutical Co., Ltd.e86d9c57-c877-49f1-a405-95a9a226ccf32023-12-04WarningsExact identifier
unii: 5QB0T2IUN0
Aluminum hydroxide and Magnesium carbonateALUMINUM HYDROXIDE, MAGNESIUM CARBONATESimpex Pharma Pvt. Ltde799a555-bfd0-4298-a5dc-aeb671815d402023-11-29WarningsExact identifier
unii: 5QB0T2IUN0
MAXIMUM STRENGTH ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONESTRATEGIC SOURCING SERVICES LLCfd00ead8-026c-6610-e053-6394a90a0f112023-11-08WarningsExact identifier
unii: 5QB0T2IUN0
REGULAR STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONESTRATEGIC SOURCING SERVICES LLCfd67566a-1078-019d-e053-6394a90a415c2023-11-08WarningsExact identifier
unii: 5QB0T2IUN0
MAXIMUM STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONESTRATEGIC SOURCING SERVICES LLCfd7a0a90-6570-c722-e053-6394a90a03f42023-11-08WarningsExact identifier
unii: 5QB0T2IUN0
ANTACID ANTIGAS NTAALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5d6916ec-e87f-6421-e053-2991aa0a33642023-11-07WarningsExact identifier
unii: 5QB0T2IUN0
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5d68366d-fee9-2acf-e053-2991aa0a7e4b2023-11-07WarningsExact identifier
unii: 5QB0T2IUN0
ANTACID ANTIGAS NTAALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5d7ed0c5-911c-299a-e053-2a91aa0aae562023-11-07WarningsExact identifier
unii: 5QB0T2IUN0
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5e1eed65-0d4c-2d02-e053-2991aa0a95c12023-11-07WarningsExact identifier
unii: 5QB0T2IUN0
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONECARDINAL HEALTH7ee3618a-43c8-2ccc-e053-2a91aa0a81152023-11-07WarningsExact identifier
unii: 5QB0T2IUN0
EXTRA STRENGTH HEARTBURN RELIEFALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECARDINAL HEALTH7ee2f64b-9719-6aa0-e053-2991aa0aeb482023-11-07WarningsExact identifier
unii: 5QB0T2IUN0
ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECARDINAL HEALTHaf5ea189-2118-4ffd-e053-2995a90aecfd2023-11-07WarningsExact identifier
unii: 5QB0T2IUN0
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECARDINAL HEALTHb1a3cef7-a05e-bb39-e053-2995a90abfb52023-11-07WarningsExact identifier
unii: 5QB0T2IUN0

Reported adverse events (FAERS/openFDA)#

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