Is Exeltis USA, Inc. FDA approved?

Exeltis USA, Inc. holds no registered establishment of its own; 11 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Exeltis USA, Inc. make?

11 products are listed under Exeltis USA, Inc. in the openFDA NDC Directory, most often as kit; tablet; capsule, liquid filled. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Exeltis USA, Inc.

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

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Registered sites: 0
Active NDC listings: 11
Labeller names: 2
Live patents: 30
Countries: 0

Catalogue

Drug listings by form and route

11 active NDC listings: 11 human prescription drug. By marketing category: UNAPPROVED DRUG OTHER 6, NDA 5.

Dosage form	NDCs
kit	4
tablet	3
capsule, liquid filled	2
capsule, gelatin coated	1
gel	1

Route	NDCs
oral	6
topical	1

Labeller name on the listing	NDCs
exeltis usa, inc.	10
exeltis usa, inc	1

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
10179140	DROSPIRENONE, SLYNDdrospirenone	use	Jun 2031
10603281	DROSPIRENONE, SLYNDdrospirenone	use	Jun 2031
10849857	DROSPIRENONE, SLYNDdrospirenone	product	Jun 2031
10987364	DROSPIRENONE, SLYNDdrospirenone	product	Jun 2031
11123299	DROSPIRENONE, SLYNDdrospirenone	product	Jun 2031
11291632	DROSPIRENONE, SLYNDdrospirenone	product	Jun 2031
11291633	DROSPIRENONE, SLYNDdrospirenone	product	Jun 2031
11351122	DROSPIRENONE, SLYNDdrospirenone	product	Jun 2031
11413249	DROSPIRENONE, SLYNDdrospirenone	use	Jun 2031
11439598	DROSPIRENONEdrospirenone	product	Jun 2031
11478487	DROSPIRENONE, SLYNDdrospirenone	product	Jun 2031
11504334	DROSPIRENONE, SLYNDdrospirenone	product	Jun 2031
11951213	DROSPIRENONE, SLYNDdrospirenone	use	Jun 2031
12090231	DROSPIRENONE, SLYNDdrospirenone	use	Jun 2031
12280151	SLYNDdrospirenone	product	Jun 2031
9603860	DROSPIRENONE, SLYNDdrospirenone	use	Jun 2031

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Benznidazole	benznidazole	tablet, oral	0642-7463NDA
Benznidazole	benznidazole	tablet, oral	0642-7464NDA
Nuvessa	metronidazole	gel, topical	0642-7466NDA
SLYND	Drospirenone	kit	0642-7470NDA
Select-OB Plus DHA Prenatal Supplement Plus DHA	.BETA.-CAROTENE, VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, Thiamine Mononitrate, Riboflavin, NIACINAMIDE, Pyridoxine Hydrochloride, Folic Acid, LEVOMEFOLATE CALCIUM, Cobalamin, Iron, MAGNESIUM OXIDE, ZINC OXIDE, and DOCONEXANT	kit	0642-0075UNAPPROVED DRUG OTHER
Strovite One Caplets	Vitamin A, Calcium Pantothenate, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Succinate, D-, Thiamine, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Biotin, Cyanocobalamin, Selenium, Magnesium Oxide, Zinc Oxide, Cupric Sulfate, Manganese, Chromium, .Alpha.-Lipoic Acid, and Lutein	tablet, oral	0642-0207UNAPPROVED DRUG OTHER
Tyblume	Levonorgestrel and Ethinyl Estradiol	kit	0642-7471NDA
Vitafol Fe Plus	DOCONEXENT, NIACINAMIDE, .ALPHA.-TOCOPHEROL ACETATE, DL-, CHOLECALCIFEROL, BETA CAROTENE, ASCORBIC ACID, THIAMINE MONONITRATE, Riboflavin, Pyridoxine Hydrochloride, CYANOCOBALAMIN, Iron, ZINC OXIDE, CUPRIC OXIDE, POTASSIUM IODIDE, MAGNESIUM OXIDE, Folic Acid, and LEVOMEFOLATE CALCIUM	capsule, liquid filled, oral	0642-7473UNAPPROVED DRUG OTHER
Vitafol One	Prenatal Supplement with DHA	capsule, gelatin coated, oral	0642-0070UNAPPROVED DRUG OTHER
Vitafol Ultra	Doconexent, Niacinamide, .Alpha.-Tocopherol Acetate, DL-, Cholecalciferol, .Beta.-Carotene, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc Oxide, Cupric Oxide, Potassium Iodide, Magnesium Oxide, Folic Acid, and Levomefolate Calcium	capsule, liquid filled, oral	0642-0093UNAPPROVED DRUG OTHER
Vitafol-OB Plus DHA Prenatal Supplement Plus DHA	Vitamin A, Ascorbic Acid, Vitamin D, .Alpha.-Tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium, Iron, Magnesium, Zinc, Copper, and Doconexent	kit	0642-0076UNAPPROVED DRUG OTHER

Enquiry

Common questions

Is Exeltis USA, Inc. FDA approved?: Exeltis USA, Inc. holds no registered establishment of its own; 11 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Exeltis USA, Inc. make?: 11 products are listed under Exeltis USA, Inc. in the openFDA NDC Directory, most often as kit; tablet; capsule, liquid filled. 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.