FDA.reportPublic FDA data

NDC 0944-4178 - CEPROTIN

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
0944-4178
Package NDCs from labels
0944-4178-02
Manufacturer
Takeda Pharmaceuticals America, Inc. | Takeda Manufacturing Austria AG | Siegfried Hameln GmbH
Effective date
2025-12-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CEPROTIN - Takeda Pharmaceuticals America, Inc. | Takeda Manufacturing Austria AG | Siegfried Hameln GmbHTakeda Pharmaceuticals America, Inc. | Takeda Manufacturing Austria AG | Siegfried Hameln GmbH2025-12-04PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0944-4178-02CEPROTIN10 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,10 mL1000 [iU] in 10mL15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0944-4178CEPROTIN (PROTEIN C CONCENTRATE HUMAN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]14Unmatched20250110_926914a9-78b2-40ea-b37d-2a55c09bf275.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROTEIN CACTIVE INGREDIENT3Z6S89TXPWCEPROTIN (PROTEIN C CONCENTRATE HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]6
PROTEIN CACTIVE MOIETY3Z6S89TXPWCEPROTIN (PROTEIN C CONCENTRATE HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]6
ALBUMIN HUMANINACTIVE INGREDIENTZIF514RVZRCEPROTIN (PROTEIN C CONCENTRATE HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCEPROTIN (PROTEIN C CONCENTRATE HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]6
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KCEPROTIN (PROTEIN C CONCENTRATE HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]6

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 47 of 53 · 1,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Natrium Muriaticum 6XSODIUM CHLORIDESeroyal USA0ebf18de-12fe-0bc4-e054-00144ff88e882022-07-07WarningsExact identifier
unii: 451W47IQ8X
ErogetoneARALIA QUINQUEFOLIA, BERBERIS VULGARIS, CAUSTICUM, CONIUM MACULATUM, DAMIANA, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIAEnergique, Inc.1e872ecd-e7a5-463d-9832-47b7046096db2022-06-28WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Cardioplegic SolutionPOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDEFresenius Kabi, USA, LLCeb360dc4-88d6-4b28-9b61-bc359e16bd222022-05-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
ACD Blood-Pack Units (PL 146 PLASTIC)ANTICOAGULANT CITRATE DEXTROSE (ACD)Fenwal, Inc.ba894daa-688e-4a9e-bd74-e71797f951bb2022-04-27Exact identifier
unii: B22547B95K
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.24a08a93-df23-474b-873e-c59ec8855f9f2022-03-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Wild Horse 777 Moisturizing NasalSODIUM CHLORIDEWild Horse 777, Inc.b0b4dadd-11fa-3dbb-e053-2995a90a20972022-03-14WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.cc14fafd-3dcd-4fc8-bdbd-6f355c3757682022-02-23Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC8b44bfd3-70a4-4b47-bc7b-590f63b8cc752022-02-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
ACNE HPCARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINCNatural Creations, Inc.b2368ab6-e233-4473-99fa-86e1fbc2a8792022-02-14WarningsExact identifier
unii: 451W47IQ8X
Sodium Citrate Blood-Pack Units, (PL 146 Plastic)ANTICOAGULANT SODIUM CITRATE SOLUTIONFenwal, Inc.a63da38d-1fea-4ee0-a70b-55c891a5ebcc2022-02-11Exact identifier
unii: B22547B95K
Sodium Citrate Blood-Pack Units, (PL 146 Plastic)ANTICOAGULANT SODIUM CITRATE SOLUTIONFenwal, Inc.ac8971a9-36d0-43c9-9121-ba5e58c28bed2022-02-11Exact identifier
unii: B22547B95K
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLCf62481fd-fcdb-4be6-ac13-29c590e925c32022-02-10Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.e44c41ae-c9c8-4dd8-ba6c-cebb585378aa2022-01-31Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile Saline Mist WalgreensSODIUM CHLORIDEWALGREEN COMPANYd6b9d4fc-b758-be32-e053-2995a90a25232022-01-29WarningsExact identifier
unii: 451W47IQ8X
Extra Strenght Saline Mist Rite AidSODIUM CHLORIDERITE AID CORPORATIONd5b30fb2-4052-4a0c-e053-2a95a90aacd52022-01-16WarningsExact identifier
unii: 451W47IQ8X
Sterile Saline Mist Rite AidSODIUM CHLORIDERITE AIDd583067e-1133-7d7d-e053-2a95a90a1e362022-01-13WarningsExact identifier
unii: 451W47IQ8X
SinuCleanse Sterile Saline MistSODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC648da2bc-bc91-4295-9e46-d3055cdc24182022-01-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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