Is Salix Pharmaceuticals, Inc. FDA approved?

Salix Pharmaceuticals, Inc. holds no registered establishment of its own; 16 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Salix Pharmaceuticals, Inc. make?

16 products are listed under Salix Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as tablet; injection, solution; kit. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Salix Pharmaceuticals, Inc.

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

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Registered sites: 0
Active NDC listings: 16
Labeller names: 4
Live patents: 60
Countries: 0

Catalogue

Drug listings by form and route

16 active NDC listings: 16 human prescription drug. By marketing category: NDA 11, ANDA 3, UNAPPROVED DRUG OTHER 2.

Dosage form	NDCs
tablet	6
injection, solution	2
kit	2
suppository	2
aerosol, foam	1
capsule, extended release	1
cream	1
suspension	1

Route	NDCs
oral	8
rectal	3
subcutaneous	2
topical	1

Labeller name on the listing	NDCs
salix pharmaceuticals, inc.	8
salix pharmaceuticals, inc	5
salix pharmaceuticals	2
salix pharmaceuticals inc.	1

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
12303592	RELISTORmethylnaltrexone bromide	product	Aug 2027
8193196	XIFAXANrifaximin	substance, product	Sept 2027
7041786	TRULANCEplecanatide	substance	Jan 2028
7687075	OSMOPREPsodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate	substance, product	Jun 2028
10456384	XIFAXANrifaximin	use	Feb 2029
10765667	XIFAXANrifaximin	use	Feb 2029
11564912	XIFAXANrifaximin	use	Feb 2029
11779571	XIFAXANrifaximin	use	Feb 2029
10314828	XIFAXANrifaximin	use	Jul 2029
10335397	XIFAXANrifaximin	use	Jul 2029
10709694	XIFAXANrifaximin	use	Jul 2029
7928115	XIFAXANrifaximin	use	Jul 2029
8829017	XIFAXANrifaximin	use	Jul 2029
8946252	XIFAXANrifaximin	use	Jul 2029
9421195	XIFAXANrifaximin	use	Jul 2029
9629828	XIFAXANrifaximin	use	Jul 2029
8420663	RELISTORmethylnaltrexone bromide	use	Sept 2029
8822490	RELISTORmethylnaltrexone bromide	product	Sept 2029
9180125	RELISTORmethylnaltrexone bromide	product	Sept 2029
9492445	RELISTORmethylnaltrexone bromide	product	Sept 2029
9724343	RELISTORmethylnaltrexone bromide	product	Sept 2029
8642573	XIFAXANrifaximin	use	Oct 2029
8969398	XIFAXANrifaximin	use	Oct 2029
8865688	APRISOmesalamine	use	May 2030
8247425	RELISTORmethylnaltrexone bromide	use	Dec 2030
10307417	RELISTORmethylnaltrexone bromide	product	Mar 2031
10376505	RELISTORmethylnaltrexone bromide	product	Mar 2031
8524276	RELISTORmethylnaltrexone bromide	product	Mar 2031
8956651	RELISTORmethylnaltrexone bromide	product	Mar 2031
9314461	RELISTORmethylnaltrexone bromide	product	Mar 2031
10307375	UCERISbudesonide	product	Sept 2031
10660858	UCERISbudesonide	product	Sept 2031
8895064	UCERISbudesonide	product	Sept 2031
9132093	UCERISbudesonide	product	Sept 2031
9192581	UCERISbudesonide	product	Sept 2031
9610321	TRULANCEplecanatide	use	Sept 2031
9919024	TRULANCEplecanatide	use	Sept 2031
9925231	TRULANCEplecanatide	product	Sept 2031
11319346	TRULANCEplecanatide	product	Mar 2032
9616097	TRULANCEplecanatide	product	Aug 2032
10011637	TRULANCEplecanatide	substance	Jun 2034
11142549	TRULANCEplecanatide	product	Jun 2034
11834521	TRULANCEplecanatide	product	Jun 2034
12146003	TRULANCEplecanatide	product	Jun 2034

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
APRISO	mesalamine	capsule, extended release, oral	65649-103NDA
Anusol HC	hydrocortisone	cream, topical	65649-401ANDA
Anusol HC	HYDROCORTISONE ACETATE	suppository, rectal	65649-411UNAPPROVED DRUG OTHER
Azasan	Azathioprine	tablet, oral	65649-231ANDA
Azasan	Azathioprine	tablet, oral	65649-241ANDA
DIURIL	CHLOROTHIAZIDE	suspension, oral	65649-311NDA
MoviPrep	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE	kit	65649-201NDA
Plenvu	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE	kit	65649-400NDA
Proctocort	HYDROCORTISONE ACETATE	suppository, rectal	65649-511UNAPPROVED DRUG OTHER
Relistor	Methylnaltrexone bromide	tablet, oral	65649-150NDA
Relistor	Methylnaltrexone bromide	injection, solution, subcutaneous	65649-551NDA
Relistor	Methylnaltrexone bromide	injection, solution, subcutaneous	65649-552NDA
Trulance Immediate release	Plecanatide	tablet, oral	65649-003NDA
Uceris	budesonide	aerosol, foam, rectal	65649-651NDA
XIFAXAN	rifaximin	tablet, oral	65649-301NDA
XIFAXAN	rifaximin	tablet, oral	65649-303NDA

Enquiry

Common questions

Is Salix Pharmaceuticals, Inc. FDA approved?: Salix Pharmaceuticals, Inc. holds no registered establishment of its own; 16 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Salix Pharmaceuticals, Inc. make?: 16 products are listed under Salix Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as tablet; injection, solution; kit. 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.