FDA.reportPublic FDA data

NDC 63833-528 - Corifact

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
63833-528
Package NDCs from labels
63833-528-01
Manufacturer
CSL Behring GmbH
Effective date
2020-08-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Corifact - CSL Behring GmbHCSL Behring GmbH2020-08-18PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63833-528-01Corifact20 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,20 mL1600 [iU] in 20mL14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63833-528CORIFACT (FACTOR XIII CONCENTRATE (HUMAN)) KIT [CSL BEHRING GMBH]14Unmatched20200926_96f1b658-01b0-43a7-9aba-693271389a78.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Factor XIII Concentrate (Human)ACTIVE INGREDIENTF7R0FBC1XDCORIFACT (FACTOR XIII CONCENTRATE (HUMAN)) KIT [CSL BEHRING GMBH]7
Factor XIII Concentrate (Human)ACTIVE MOIETYF7R0FBC1XDCORIFACT (FACTOR XIII CONCENTRATE (HUMAN)) KIT [CSL BEHRING GMBH]7
Albumin (Human)INACTIVE INGREDIENTZIF514RVZRCORIFACT (FACTOR XIII CONCENTRATE (HUMAN)) KIT [CSL BEHRING GMBH]7
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XCORIFACT (FACTOR XIII CONCENTRATE (HUMAN)) KIT [CSL BEHRING GMBH]7
Sodium HydroxideINACTIVE INGREDIENT55X04QC32ICORIFACT (FACTOR XIII CONCENTRATE (HUMAN)) KIT [CSL BEHRING GMBH]7

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 17 of 51 · 1,019 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AZO Yeast PlusCANDIDA ALBICANS, WOOD CREOSOTE, SODIUM CHLORIDE, AND SULFURi-Health, Inc.22845cac-8011-4ea8-b35e-b72973eddb442025-11-07WarningsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEHenry Schein, Inc.2e81ffca-05c6-4fa0-8911-4b3cbfa713512025-11-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDERising Pharma Holdings, Inc.42870188-b1d7-4934-a6c0-310530497dac2025-11-07WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEHenry Schein, Inc.d8b8d796-bfba-42af-a859-99d7768715582025-11-07Adverse reactionsExact identifier
unii: 451W47IQ8X
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic Sodium ChlorideSODIUM CHLORIDEHenry Schein, Inc.31188cdf-7bc8-4d78-bfaf-c1dc9f851fd42025-11-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.d3d29c8f-c326-4097-814a-7f4e08c670682025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
RingersSODIUM CHLORIDE, CALCIUM CHLORIDE, AND POTASSIUM CHLORIDEB. Braun Medical Inc.01721071-af03-4894-95c1-10b8bc64b8882025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Dextrose in Lactated RingersDEXTROSE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.190da07e-a616-46e6-b4e5-1c0ba39306e52025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.f6d82772-638c-4584-b9d3-8833669f59632025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Com-Pare2 Dual Yeast Relief Plus Multi-symptom FormulaCANDIDA ALBICANS, WOOD CREOSOTE, SODIUM CHLORIDE, SULPHURTRP Company42b6b9b9-a673-0bba-e063-6394a90a88662025-11-03WarningsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEICU Medical Inc.d8ee14e9-6733-4813-9f21-2b043a5f71882025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEICU Medical Inc.4555b1bf-6d97-4798-a63d-6d34291c85ce2025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE AND POTASSIUM CHLORIDEICU Medical Inc.9dd1c001-73b3-41d4-9a96-61f6ad3a5dc32025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.3cfdeee0-ff14-4341-8396-b11c2a037c602025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.5f372b75-d7a4-471e-8ac6-290040fc84b02025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE AND POTASSIUM CHLORIDEICU Medical Inc.243fe8fc-996a-4855-8daf-069628e547c42025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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