FDA.reportPublic FDA data

NDC 0169-7855 - NOVOEIGHT

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
0169-7855
Package NDCs from labels
0169-7855-11
Manufacturer
Novo Nordisk
Effective date
2020-07-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NOVOEIGHT - Novo NordiskNovo Nordisk2020-07-31PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0169-7855-11NOVOEIGHT4 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,4 mL375 [iU] in 1mL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0169-7855NOVOEIGHT (ANTIHEMOPHILIC FACTOR RECOMBINANT) KIT [NOVO NORDISK]12Unmatched20240524_0a19a631-f494-48ac-8cab-7d572bf7b03d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANTACTIVE INGREDIENTP89DR4NY54NOVOEIGHT (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [NOVO NORDISK]5
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANTACTIVE MOIETYP89DR4NY54NOVOEIGHT (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [NOVO NORDISK]5
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MNOVOEIGHT (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [NOVO NORDISK]5
HISTIDINEINACTIVE INGREDIENT4QD397987ENOVOEIGHT (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [NOVO NORDISK]5
METHIONINEINACTIVE INGREDIENTAE28F7PNPLNOVOEIGHT (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [NOVO NORDISK]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNOVOEIGHT (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [NOVO NORDISK]5
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNOVOEIGHT (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [NOVO NORDISK]5
SUCROSEINACTIVE INGREDIENTC151H8M554NOVOEIGHT (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [NOVO NORDISK]5

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 23 of 48 · 945 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bestmade Natural Products BIO5 Lactose FreeFERR PHOS, KALI MUR, NAT MUR, KALI SULPHBestmade Natural Products30225814-b9d7-f16a-e063-6294a90a01942025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO6 Lactose FreeFERR PHOS, KALI MUR, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Products302292bd-9c38-2638-e063-6294a90a965d2025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO11 Lactose FreeFERR PHOS, KALI MUR, KALI SULPH, NAT MUR, NAT SULPHBestmade Natural Products3025f91f-bc0a-691c-e063-6294a90ad1362025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO12 Lactose FreeFERR PHOS, NAT MUR, KALI PHOS, MAG PHOSBestmade Natural Products30262ecd-5bd9-80d0-e063-6294a90ab1db2025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO20CALC FLUOR, CALC SULPH, KALI SULPH, NAT MUR, NAT SULPHBestmade Natural Products300d4674-5c2e-01b6-e063-6294a90acbf92025-03-11WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO27NAT MUR, KALI PHOS, CALC PHOSBestmade Natural Products300e8ba5-1b16-ad40-e063-6294a90a674d2025-03-11WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO28CALC FLUOR, CALC PHOS, CALC SULPH, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEABestmade Natural Products300ead4c-6937-d597-e063-6394a90ad6bb2025-03-11WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO1 Lactose FreeCALC PHOS, FERR PHOS, KALI PHOS, NAT MURBestmade Natural Products3013926f-ecd2-d376-e063-6294a90a47432025-03-11WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO2 Lactose FreeKALI PHOS, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Products3013d3a9-7f20-4d19-e063-6394a90a58142025-03-11WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO4CALC FLUOR, KALI MUR, NAT MUR, SILICEABestmade Natural Products2ffcffd8-94ba-3a4c-e063-6394a90a24ee2025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO5FERR PHOS, KALI MUR, NAT MUR, KALI SULPHBestmade Natural Products2ffd4d8f-75bf-1b9b-e063-6294a90abc362025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO6FERR PHOS, KALI MUR, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Products2ffd93dd-1084-4b24-e063-6294a90a14332025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO11FERR PHOS, KALI MUR, KALI SULPH, NAT MUR, NAT SULPHBestmade Natural Products2fff2361-a171-2249-e063-6394a90a8b652025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO12FERR PHOS, NAT MUR, KALI PHOS, MAG PHOSBestmade Natural Products2fff612e-16dc-dcbf-e063-6294a90a22ad2025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MURBestmade Natural Products30002ebe-3b38-cb35-e063-6394a90a8f7e2025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO1CALC PHOS FERR PHOS, KALI PHOS, NAT MURBestmade Natural Products2fd724b6-c6cf-652a-e063-6294a90ab4d72025-03-08WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO2KALI PHOS, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Products2fd794c0-a553-e3f5-e063-6294a90a522a2025-03-08WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM253CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, MAG PHOS, NAT MURBestmade Natural Products2fa9913f-0593-f77b-e063-6394a90ab6b22025-03-06WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM254APIS MEL, BRYONIA, GELSEMIUM, NAT MUR, PULSATILLABestmade Natural Products2fa9bb2c-848b-06ef-e063-6394a90ad0f02025-03-06WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Nat MurNATRUM MURIATICUMBestmade Natural Products2fa9f3a3-91e3-2f8e-e063-6294a90afda82025-03-06WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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