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
Label	Manufacturer	Effective date	Type
NOVOEIGHT - Novo Nordisk	Novo Nordisk	2020-07-31	PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0169-7855-11	NOVOEIGHT	4 mL in 1 VIAL, GLASS	INJECTION, POWDER, LYOPHILIZED,	4 mL	375 [iU] in 1mL	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0169-7855	NOVOEIGHT (ANTIHEMOPHILIC FACTOR RECOMBINANT) KIT [NOVO NORDISK]	12	Unmatched	20240524_0a19a631-f494-48ac-8cab-7d572bf7b03d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT	ACTIVE INGREDIENT	P89DR4NY54	NOVOEIGHT (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [NOVO NORDISK]	5
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT	ACTIVE MOIETY	P89DR4NY54	NOVOEIGHT (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [NOVO NORDISK]	5
CALCIUM CHLORIDE	INACTIVE INGREDIENT	M4I0D6VV5M	NOVOEIGHT (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [NOVO NORDISK]	5
HISTIDINE	INACTIVE INGREDIENT	4QD397987E	NOVOEIGHT (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [NOVO NORDISK]	5
METHIONINE	INACTIVE INGREDIENT	AE28F7PNPL	NOVOEIGHT (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [NOVO NORDISK]	5
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	NOVOEIGHT (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [NOVO NORDISK]	5
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	NOVOEIGHT (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [NOVO NORDISK]	5
SUCROSE	INACTIVE INGREDIENT	C151H8M554	NOVOEIGHT (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 48 of 48 · 945 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	2a96096d-43cc-49b7-af53-b53c17f41001	2014-07-25	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	b3b4b176-41f0-4ca8-90d4-3fba5707564a	2014-02-21		Exact identifier unii: 451W47IQ8X
TIS-U-SOL	SODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATE	Baxter Healthcare Corporation	9da4121f-d62d-4da4-8dfb-0494da16015f	2014-02-21		Exact identifier unii: 451W47IQ8X
Ringers	SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,	Baxter Healthcare Corporation	e1953d54-818d-46a6-8532-518ebae6d84e	2012-06-13		Exact identifier unii: 451W47IQ8X unii: M4I0D6VV5M
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	f09f80bf-2f8b-4420-865d-aec2d5e5cd4d	2012-06-12		Exact identifier unii: 451W47IQ8X unii: M4I0D6VV5M

Reported adverse events (FAERS/openFDA)#

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