Is Medunik USA FDA approved?

Medunik USA holds no registered establishment of its own; 4 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Medunik USA make?

4 products are listed under Medunik USA in the openFDA NDC Directory, most often as tablet, film coated; kit; pellet. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Medunik USA

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

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Registered sites: 0
Active NDC listings: 4
Labeller names: 2
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

4 active NDC listings: 4 human prescription drug. By marketing category: NDA 4.

Dosage form	NDCs
tablet, film coated	2
kit	1
pellet	1

Route	NDCs
oral	3

Labeller name on the listing	NDCs
medunik	2
medunik usa	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
PHEBURANE	Sodium phenylbutyrate	kit	71770-200NDA
PHEBURANE	Sodium phenylbutyrate	pellet, oral	71770-210NDA
Siklos	hydroxyurea	tablet, film coated, oral	71770-105NDA
Siklos	hydroxyurea	tablet, film coated, oral	71770-120NDA

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Other companies listing sodium phenylbutyrate

Zydus Pharmaceuticals USA Inc.1 site · 626 NDC
Navinta LLC1 site · 19 NDC

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Common questions

Is Medunik USA FDA approved?: Medunik USA holds no registered establishment of its own; 4 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Medunik USA make?: 4 products are listed under Medunik USA in the openFDA NDC Directory, most often as tablet, film coated; kit; pellet. 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.