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 5 of 12 · 230 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAXIMUM STRENGTH ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEWALGREEN COMPANY7cd8fdf4-f762-f936-e053-2a91aa0aa6ee2025-11-19WarningsExact identifier
unii: 5QB0T2IUN0
GERI-LANTA ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corpa7d7298f-44d6-4e09-8578-7fe3112430022025-11-19WarningsExact identifier
unii: 5QB0T2IUN0
GERI-MOX MAX CHERRYALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corp8e57bcf5-2960-4c41-8bf2-83cb1ee501682025-11-19WarningsExact identifier
unii: 5QB0T2IUN0
REGULAR STRENGTH ANTACID/ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONERUGBY LABORATORIESb244fce9-9626-e947-e053-2995a90ab8f92025-11-17WarningsExact identifier
unii: 5QB0T2IUN0
MAXIMUM STRENGTH ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS3ce054f3-2953-5f7d-e054-00144ff8d46c2025-11-11WarningsExact identifier
unii: 5QB0T2IUN0
Extra Strength AntacidALUMINUM HYDROXIDE AND MAGNESIUM CARBONATETARGET CORPORATION3d987f0b-4d7e-489e-ab19-efe1ee11009a2025-11-04WarningsExact identifier
unii: 5QB0T2IUN0
ADVANCED REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEWALGREEN COMPANY5faf6229-b0fd-58df-e053-2a91aa0ab3bb2025-10-30WarningsExact identifier
unii: 5QB0T2IUN0
equate Extra Strength AntacidALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEWal-Mart Stores,Inc448d1c72-2308-4041-8ba6-dd1e0802cc472025-10-27WarningsExact identifier
unii: 5QB0T2IUN0
Sugar CravingsCINNAMIC ACID, PHLORIDZINUM, ARGENTUM NITRICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, BEET SUGAR, DEXTROSE, D-RIBOSE, FRUCTOSE, LYCOPODIUM CLAVATUM, MAPLE SUGAR, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, MALVIN, ADRENOCORTICOTROPHIN, DYSENTERY BACILLUS, MORGAN GAERTNERDr. Donna Restivo DC401873ba-ae1b-4506-a2e8-c6c0e5ff27f52025-10-21WarningsExact identifier
unii: J2B2A4N98G
Extra Strength Antacid Original FlavorALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECardinal Health1fe459f6-be7f-4c59-b33b-f13ec17071f22025-10-14WarningsExact identifier
unii: 5QB0T2IUN0
E-Z-DiskBARIUM SULFATEE-Z-EM, INC.c759668b-5cf1-b237-00c8-a5e4733b6f4c2025-09-29Warnings, Adverse reactionsExact identifier
unii: 25BB7EKE2E
ProCure DryDroxALUMINUM HYDROXIDE GEL 2%Twin Med LLC3ab4efb6-bd31-2583-e063-6294a90a415b2025-09-15WarningsExact identifier
unii: 5QB0T2IUN0
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepack3aeb6bb1-bc43-4fe7-83f2-36cd0bf461022025-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855296
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepack8eae6b6c-1851-4342-b320-7e18968946582025-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855302
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepacka1860448-d4ef-40f2-b096-056429ca3aea2025-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855288
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepackd166f83b-7052-4dc7-b7d4-47faae7dcaed2025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855324
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepacke7f78a33-71eb-4aac-ba9d-70f75136fab02025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855332
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepack694e258d-86bd-440c-870b-a7d27fb1c4672025-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855296
unii: 6153CWM0CL
MINTOX MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEATLANTIC BIOLOGICALS CORP.ac6a47e7-972f-4b82-96da-89926d345e9f2025-07-31WarningsExact identifier
unii: 5QB0T2IUN0
Maximum Strength Antacid and AntigasALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEMeijer, Inc.30a0455d-63e0-95cc-e063-6394a90ada6b2025-07-30WarningsExact identifier
unii: 5QB0T2IUN0

Reported adverse events (FAERS/openFDA)#

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