Is Genmab US, Inc. FDA approved?

Genmab US, Inc. holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Genmab US, Inc. make?

2 products are listed under Genmab US, Inc. in the openFDA NDC Directory, most often as injection, solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Genmab US, Inc.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 2
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

2 active NDC listings: 2 human prescription drug. By marketing category: BLA 2.

Dosage form	NDCs
injection, solution	2

Route	NDCs
subcutaneous	2

Labeller name on the listing	NDCs
genmab us, inc.	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
EPKINLY	epcoritamab-bysp	injection, solution, subcutaneous	82705-002BLA
EPKINLY	epcoritamab-bysp	injection, solution, subcutaneous	82705-010BLA

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Common questions

Is Genmab US, Inc. FDA approved?: Genmab US, Inc. holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Genmab US, Inc. make?: 2 products are listed under Genmab US, Inc. in the openFDA NDC Directory, most often as injection, solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.