Is Millicent US, Inc. FDA approved?

Millicent US, Inc. holds no registered establishment of its own; 6 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Millicent US, Inc. make?

6 products are listed under Millicent US, Inc. in the openFDA NDC Directory, most often as insert; kit; ring. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Millicent US, Inc.

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

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Registered sites: 0
Active NDC listings: 6
Live patents: 3
Countries: 0

Catalogue

Drug listings by form and route

6 active NDC listings: 5 human prescription drug, 1 drug for further processing. By marketing category: NDA 5, DRUG FOR FURTHER PROCESSING 1.

Dosage form	NDCs
insert	2
kit	2
ring	2

Route	NDCs
vaginal	4

Labeller name on the listing	NDCs
millicent us, inc.	6

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
8629129	INTRAROSAprasterone	product	Aug 2028
8957054	INTRAROSAprasterone	use	Jan 2030
8268806	INTRAROSAprasterone	product	Mar 2031

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
FEMLYV	Norethindrone Acetate/Ethinyl Estradiol	kit	72495-601NDA
Femring	estradiol acetate	ring, vaginal	72495-201NDA
Femring	estradiol acetate	ring, vaginal	72495-202NDA
Intrarosa	Prasterone	insert, vaginal	72495-401NDA
Intrarosa	Prasterone	insert, vaginal	72495-501NDA
-	norethindrone acetate/ethinyl estradiol	kit	72495-600DRUG FOR FURTHER PROCESSING

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Other companies listing prasterone

Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd.1 site · 11 NDC

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Common questions

Is Millicent US, Inc. FDA approved?: Millicent US, Inc. holds no registered establishment of its own; 6 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Millicent US, Inc. make?: 6 products are listed under Millicent US, Inc. in the openFDA NDC Directory, most often as insert; kit; ring. 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.