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 9 of 48 · 956 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RHODODIUMACTEA RACEMOSA, APIS MELL, CALC CARB, GRAPHITES, IODIUM, NATRUM MUR, PULSATILLA, RHODODENDRONBM Private Limited3b3bcba2-6f9e-cd94-e063-6394a90a77012026-02-15WarningsExact identifier
unii: 451W47IQ8X
Walgreens ULTRA FINE MOISTURIZING SALINE MISTNASAL MISTWALGREEN COMPANY48fef521-1b1d-d0d5-e063-6394a90ac7b12026-02-10WarningsExact identifier
unii: 451W47IQ8X
Walgreens SALINE MISTNASAL MISTWALGREEN COMPANY44815675-cc1d-a582-e063-6394a90ae8f62026-02-10WarningsExact identifier
unii: 451W47IQ8X
0.9 percentsalineSODIUM CHLORIDEHuizhou Jinsheng Medical Technology Co., Ltd487cb4fc-2e0b-020f-e063-6294a90a45262026-02-03WarningsExact identifier
unii: 451W47IQ8X
0.9salineSODIUM CHLORIDEHuizhou Jinsheng Medical Technology Co., Ltd49e76aca-ca2b-3b95-e063-6394a90a875e2026-02-03WarningsExact identifier
unii: 451W47IQ8X
0.9%salineSODIUM CHLORIDEHuizhou Jinsheng Medical Technology Co., Ltd49e7b329-e4e5-6991-e063-6294a90ac8172026-02-03WarningsExact identifier
unii: 451W47IQ8X
Calcium ChlorideCALCIUM CHLORIDEHospira, Inc.c4c65e48-85f8-4dcf-6281-06e40959cc792026-02-02Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
Adrenal SupportADRENALINUM, BERBERIS VULGARIS, ARGENTUM NITRICUM, NATRUM MURIATICUM, VANADIUM METALLICUM, OLEUM MORRHUAE, PETROLEUMNaturalCarecee52757-a86e-4251-b65f-954ac85f4e7e2026-01-30WarningsExact identifier
unii: 451W47IQ8X
Vital Female Sexual EnergyAGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SABAL SERRULATA, SEPIA, THUJA OCCIDENTALISLiddell Laboratories, Inc.7b15d6fa-eb04-41d2-8a01-6e7408ccf4d32026-01-30WarningsExact identifier
unii: 451W47IQ8X
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
CVS ULTRA FINE MOISTURIZING SALINE MISTNASAL MISTCVS44821c47-63f9-5d0a-e063-6394a90a555d2026-01-29WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDENephron Pharmaceuticals Corporationa4edf2d5-a9ff-30d4-e053-2995a90a56502026-01-26Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEProPharma Distribution48d73434-e65b-dc98-e063-6294a90affa22026-01-20Adverse reactionsExact identifier
unii: 451W47IQ8X
Equate Comfort Flow Sinus washSINUS WASHWALMART INC9e911eef-ca99-9902-e053-2a95a90aab0e2026-01-19WarningsExact identifier
unii: 451W47IQ8X
EQUATE PREMIUM SALINESODIUM CHLORIDE 0.65%Walmart Stores, Inc.1e17f022-f513-140d-e063-6394a90a379e2026-01-19WarningsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLCd98bf9f7-30ec-4927-a577-cabad192cb182026-01-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium Chloride HypertonicitySODIUM CHLORIDECVS Pharmacy9245d842-7f78-42d8-83ba-8eb9ec8dbc0d2026-01-15WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride HypertonicitySODIUM CHLORIDECVS PHARMACYd5cc6cd1-ddf8-4f5b-a021-204cdda0db942026-01-15WarningsExact identifier
unii: 451W47IQ8X
calcium chlorideCALCIUM CHLORIDESQUARE PHARMACEUTICALS PLC.753c3973-6522-4d33-811b-b63a4e8cc5852026-01-14Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
Constipation ReliefALUMINUM OXIDE, BRYONIA ALBA ROOT, SODIUM CHLORIDE, GRAPHITE, SILICON DIOXIDEHomeocare Laboratories62374240-cd14-44e2-9405-5f8996faf0472026-01-12WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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