Is HRA Pharma Rare Diseases FDA approved?

HRA Pharma Rare Diseases 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 HRA Pharma Rare Diseases make?

2 products are listed under HRA Pharma Rare Diseases in the openFDA NDC Directory, most often as capsule, gelatin coated; tablet. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

HRA Pharma Rare Diseases

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

Request a quote Claim this profile

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: NDA 2.

Dosage form	NDCs
capsule, gelatin coated	1
tablet	1

Route	NDCs
oral	2

Labeller name on the listing	NDCs
hra pharma rare diseases	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Lysodren	mitotane	tablet, oral	76336-080NDA
Metopirone	Metyrapone	capsule, gelatin coated, oral	76336-455NDA

Compare

Other companies listing metyrapone

Minakem Beuvry Production1 site · 4 NDC
ESTEVE PHARMACEUTICALS, S.A.0 sites · 8 NDC

Enquiry

Common questions

Is HRA Pharma Rare Diseases FDA approved?: HRA Pharma Rare Diseases 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 HRA Pharma Rare Diseases make?: 2 products are listed under HRA Pharma Rare Diseases in the openFDA NDC Directory, most often as capsule, gelatin coated; tablet. 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.