Is RedHill Biopharma Ltd FDA approved?

RedHill Biopharma Ltd 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 RedHill Biopharma Ltd make?

2 products are listed under RedHill Biopharma Ltd in the openFDA NDC Directory, most often as capsule, delayed release; tablet, film coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

RedHill Biopharma Ltd

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: NDA 2.

Dosage form	NDCs
capsule, delayed release	1
tablet, film coated	1

Route	NDCs
oral	2

Labeller name on the listing	NDCs
redhill biopharma ltd	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
MOVANTIK	naloxegol oxalate	tablet, film coated, oral	57841-1301NDA
Talicia	omeprazole magnesium, amoxicillin and rifabutin	capsule, delayed release, oral	57841-1150NDA

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Other companies listing naloxegol oxalate

Averitas Pharma, Inc.0 sites · 5 NDC

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Common questions

Is RedHill Biopharma Ltd FDA approved?: RedHill Biopharma Ltd 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 RedHill Biopharma Ltd make?: 2 products are listed under RedHill Biopharma Ltd in the openFDA NDC Directory, most often as capsule, delayed release; tablet, film coated. 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.