Is Santarus, Inc.. FDA approved?

Santarus, Inc.. holds no registered establishment of its own; 8 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Santarus, Inc.. make?

8 products are listed under Santarus, Inc.. in the openFDA NDC Directory, most often as tablet, film coated, extended release; capsule; powder, for suspension. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Santarus, Inc..

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

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Registered sites: 0
Active NDC listings: 8
Labeller names: 3
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

8 active NDC listings: 8 human prescription drug. By marketing category: NDA 8.

Dosage form	NDCs
tablet, film coated, extended release	3
capsule	2
powder, for suspension	2
tablet, extended release	1

Route	NDCs
oral	8

Labeller name on the listing	NDCs
santarus, inc..	4
santarus, inc.	3
santarus inc.	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Glumetza	metformin hydrochloride	tablet, film coated, extended release, oral	68012-002NDA
Glumetza	metformin hydrochloride	tablet, film coated, extended release, oral	68012-003NDA
Glumetza	metformin hydrochloride	tablet, film coated, extended release, oral	68012-004NDA
Uceris	budesonide	tablet, extended release, oral	68012-309NDA
ZEGERID	omeprazole and sodium bicarbonate	powder, for suspension, oral	68012-052NDA
ZEGERID	omeprazole and sodium bicarbonate	powder, for suspension, oral	68012-054NDA
ZEGERID	omeprazole and sodium bicarbonate	capsule, oral	68012-102NDA
ZEGERID	omeprazole and sodium bicarbonate	capsule, oral	68012-104NDA

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Other companies listing omeprazole and sodium bicarbonate

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Common questions

Is Santarus, Inc.. FDA approved?: Santarus, Inc.. holds no registered establishment of its own; 8 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Santarus, Inc.. make?: 8 products are listed under Santarus, Inc.. in the openFDA NDC Directory, most often as tablet, film coated, extended release; capsule; powder, for suspension. 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.