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 6 of 12 · 230 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dairy-Grain-NightshadeIRIS VERS., SOLIDAGO, ANTIMON. CRUD., ARG. NIT., ARSENICUM ALB., AVENA, BAPTISIA, BELLADONNA, BRYONIA, CAPSICUM, CARDUUS BEN., CINCHONA, DULCAMARA, FAGOPYRUM, GELSEMIUM, HYOSCYAMUS, IPECAC., LAC VAC., LACHESIS, LYCOPODIUM, NAT. MUR., PHOS., PODOPH. PELT., PULSATILLA, RHUS TOX., SAC. LAC., SECALE, SEPIA, STRAMONIUM, TABACUM, TRITICUM, USTILAGO MAIDIS, VERBASCUM, LYCOPERSICUM, SOLANUM NIG., SOLANUM TUB., STIGMATA, TORULA CEREVISIAE.Newton Laboratories, Inc.99fcbd61-ecc8-cf9d-e053-2995a90aebeb2025-07-25WarningsExact identifier
unii: J2B2A4N98G
Warfarin SodiumWARFARINGolden State Medical Supply, Inc.a2f6c9f7-87dc-7428-e053-2995a90a1de62025-07-17Boxed 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
Aluminum Hydroxide, Magnesium Hydroxide, and DimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND DIMETHICONEAmerican Health Packaging23539e7e-a723-460f-892f-dac5bbbb9b162025-07-15WarningsExact identifier
unii: 5QB0T2IUN0
Warfarin SodiumWARFARIN SODIUMPD-Rx Pharmaceuticals, Inc.21255cd5-3c2e-4574-9620-9347d14256b32025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855332
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepack4f8afe14-897c-458b-b76f-9bae6fa6110e2025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855312
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepack44077bb7-6007-4c15-bbcd-a7a02ac081ce2025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855332
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepack7f604dc4-c2cd-4b1f-b94d-b5877a1be66b2025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855344
unii: 6153CWM0CL
Warfarin SodiumWARFARIN SODIUMGolden State Medical Supply, Inc.ba8b4ead-d080-91e7-e053-2995a90a82fe2025-07-10Boxed 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
REGULAR STRENGTH ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEWALGREEN COMPANY7cd9234e-d1cc-4cce-e053-2991aa0a457e2025-07-09WarningsExact identifier
unii: 5QB0T2IUN0
JantovenWARFARIN SODIUMUpsher-Smith Laboratories, LLC19a69a72-ac5d-45d5-a94d-a5aaecbe47302025-07-08Boxed 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
Aluminum Hydroxide, Magnesium Hydroxide, and SimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEMajor Pharmaceuticals1bc90fa7-fcce-4a9b-862f-f30ab602ecab2025-07-07WarningsExact identifier
unii: 5QB0T2IUN0
Aluminum Hydroxide, Magnesium Hydroxide and SimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONERising Pharma Holdings, Inc.982129d4-3cbf-4793-a861-d6c8f34bedc32025-07-01WarningsExact identifier
unii: 5QB0T2IUN0
Warfarin SodiumWARFARIN SODIUMTeva Pharmaceuticals USA, Inc.0cbce382-9c88-4f58-ae0f-532a841e8f952025-06-17Boxed 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
Gaviscon Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEHaleon US Holdings LLC7f367927-c366-465c-a059-e2cfb337d5622025-06-11WarningsExact identifier
unii: 5QB0T2IUN0
Warfarin SodiumWARFARIN SODIUMSun Pharmaceutical Industries, Inc.8ad881e0-ca41-42ad-9d7d-eb85b3a30af02025-06-10Boxed 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
Aluminum Hydroxide, Magnesium Hydroxide, and SimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEAmerican Health Packaging2faf291e-1d62-412a-a05e-e992cb7def6a2025-05-30WarningsExact identifier
unii: 5QB0T2IUN0
GERI-LANTA ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEATLANTIC BIOLOGICALS CORP.043207dd-5e1c-4c78-b75a-7d341d71b1172025-05-12WarningsExact identifier
unii: 5QB0T2IUN0
KO-LANTAALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corp31a6011d-5c61-d0fe-e063-6294a90ac5892025-03-31WarningsExact identifier
unii: 5QB0T2IUN0
Warfarin SodiumWARFARINCoupler LLC2f2119e8-f583-ba16-e063-6394a90a13a22025-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855344
unii: 6153CWM0CL
Maximum Strength Antacid CherryALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEHarris Teeter, LLC2c4fc835-a9ad-2666-e063-6394a90a20ac2025-02-12WarningsExact identifier
unii: 5QB0T2IUN0

Reported adverse events (FAERS/openFDA)#

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