FDA.reportPublic FDA data

NDC 0169-7218 - NovoSeven RT

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
0169-7218
Package NDCs from labels
0169-7218-11
Manufacturer
Novo Nordisk | Novo Nordisk A/S
Effective date
2020-07-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NovoSeven RT - Novo Nordisk | Novo Nordisk A/SNovo Nordisk | Novo Nordisk A/S2020-07-10PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0169-7218-11NovoSevenRT8 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,8 mL1 mg in 1mL21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0169-7218NOVOSEVEN RT (COAGULATION FACTOR VIIA (RECOMBINANT)) KIT [NOVO NORDISK]21Unmatched20221115_ea65c32f-8518-4383-b621-17056c0eebc0.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COAGULATION FACTOR VIIA RECOMBINANT HUMANACTIVE INGREDIENTAC71R787OVNOVOSEVEN RT (COAGULATION FACTOR VIIA (RECOMBINANT)) KIT [NOVO NORDISK]15
COAGULATION FACTOR VIIA RECOMBINANT HUMANACTIVE MOIETYAC71R787OVNOVOSEVEN RT (COAGULATION FACTOR VIIA (RECOMBINANT)) KIT [NOVO NORDISK]15
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MNOVOSEVEN RT (COAGULATION FACTOR VIIA (RECOMBINANT)) KIT [NOVO NORDISK]15
DIGLYCINEINACTIVE INGREDIENT10525P22U0NOVOSEVEN RT (COAGULATION FACTOR VIIA (RECOMBINANT)) KIT [NOVO NORDISK]15
HISTIDINEINACTIVE INGREDIENT4QD397987ENOVOSEVEN RT (COAGULATION FACTOR VIIA (RECOMBINANT)) KIT [NOVO NORDISK]15
MANNITOLINACTIVE INGREDIENT3OWL53L36ANOVOSEVEN RT (COAGULATION FACTOR VIIA (RECOMBINANT)) KIT [NOVO NORDISK]15
METHIONINEINACTIVE INGREDIENTAE28F7PNPLNOVOSEVEN RT (COAGULATION FACTOR VIIA (RECOMBINANT)) KIT [NOVO NORDISK]15
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNOVOSEVEN RT (COAGULATION FACTOR VIIA (RECOMBINANT)) KIT [NOVO NORDISK]15
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNOVOSEVEN RT (COAGULATION FACTOR VIIA (RECOMBINANT)) KIT [NOVO NORDISK]15
SUCROSEINACTIVE INGREDIENTC151H8M554NOVOSEVEN RT (COAGULATION FACTOR VIIA (RECOMBINANT)) KIT [NOVO NORDISK]15
WATERINACTIVE INGREDIENT059QF0KO0RNOVOSEVEN RT (COAGULATION FACTOR VIIA (RECOMBINANT)) KIT [NOVO NORDISK]15

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 22 of 56 · 1,117 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calcium ChlorideCALCIUM CHLORIDEProPharma Distribution3eef0115-26f6-2abe-e063-6294a90aa2892025-09-16Adverse reactionsExact identifier
unii: M4I0D6VV5M
PerikabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCc2eb5522-8572-45f4-869d-42f9fd251bb62025-09-15Warnings, Adverse reactionsExact identifier
unii: 4QD397987E
unii: AE28F7PNPL
unii: M4I0D6VV5M
KabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCafeb4837-a759-4484-a76e-e04611c459e72025-09-11Warnings, Adverse reactionsExact identifier
unii: 4QD397987E
unii: AE28F7PNPL
unii: M4I0D6VV5M
GAVILYTE-NPOLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATELupin Pharmaceuticals,Inc.27195187-75a3-431f-90d9-84da1b94e8492025-09-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
GaviLyte - C TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACKLupin Pharmaceuticals,Inc.a8b15625-ca7c-4d57-9f36-3ac2a6d136652025-09-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
GAVILYTE G TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESLupin Pharmaceuticals,Inc.3978822b-6473-4072-9f80-20ceb9bea3552025-09-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltd9083a01b-2fbe-4e04-9eec-bf4f65950ec72025-09-09WarningsExact identifier
unii: 451W47IQ8X
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM ,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltdc14c79ab-85bb-45f2-83d1-1d9c298ffdfd2025-09-08WarningsExact identifier
unii: 451W47IQ8X
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Polyethylene Glycol 3350 and electrolytes - UnflavoredPOLYETHYLENE GLYCOL 3350 AND ELECTROLYTES - UNFLAVOREDStrides Pharma Science Limited48c741a9-9039-4fdb-a875-86d4ea9682822025-09-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - UnflavoredPOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE - UNFLAVOREDStrides Pharma Science Limited37c111ec-5b62-42b9-bbb2-3b0c530e34c92025-09-01Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Dextrose and Sodium ChlorideDEXTROSE AND SODIUM CHLORIDEBaxter Healthcare Companydcbf1907-1841-4afc-ab5d-a9893a2d72562025-08-26Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
terrasil Fast and Natural Wart RemovalGRAPHITE 10X, NATRUM MURIATICUM 3X, SYMPHYTUM OFFICINALE (COMFREY) 1X, THUJA OCCIDENTALIS 3XAidance Scientific, Inc.3d367c0f-5a28-eded-e063-6394a90ad2dc2025-08-25WarningsExact identifier
unii: 451W47IQ8X
Cold Sore Treatment Extra StrengthECHINACEA ANGUSTIFOLIA WHOLE, SODIUM CHLORIDE, THUJA OCCIDENTALIS LEAFY TWIG, AND CALENDULA OFFICINALIS FLOWERING TOPForces of Nature0a5d32dc-c0e7-404e-85f2-6c3a338560ba2025-08-22WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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