NDC 0169-8100 Esperoct

Antihemophilic Factor (recombinant), Glycopegylated-exei

NDC Product Code 0169-8100

NDC 0169-8100-01

Package Description: 1 KIT in 1 KIT * 4 mL in 1 VIAL, GLASS (0169-8101-11) * 4 mL in 1 SYRINGE, GLASS (0169-8008-98)

NDC Product Information

Esperoct with NDC 0169-8100 is a a plasma derivative product labeled by Novo Nordisk. The generic name of Esperoct is antihemophilic factor (recombinant), glycopegylated-exei. The product's dosage form is kit and is administered via form.

Labeler Name: Novo Nordisk

Dosage Form: Kit - A packaged collection of related material.

Product Type: Plasma Derivative What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Novo Nordisk
Labeler Code: 0169
FDA Application Number: BLA125671 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: BLA - A product marketed under an approved Biologic License Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-19-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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