Is Hisun Pharmaceuticals USA, Inc. FDA approved?

Hisun Pharmaceuticals USA, Inc. holds no registered establishment of its own; 12 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Hisun Pharmaceuticals USA, Inc. make?

12 products are listed under Hisun Pharmaceuticals USA, Inc. in the openFDA NDC Directory, most often as injection, solution; tablet, film coated; injection, powder, for solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Hisun Pharmaceuticals USA, Inc.

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

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Registered sites: 0
Active NDC listings: 12
Labeller names: 2
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

12 active NDC listings: 12 human prescription drug. By marketing category: ANDA 12.

Dosage form	NDCs
injection, solution	4
tablet, film coated	4
injection, powder, for solution	2
injection, powder, lyophilized, for solution	1
tablet	1

Route	NDCs
intravenous	7
oral	5

Labeller name on the listing	NDCs
hisun pharmaceuticals usa, inc.	9
hisun pharmaceuticals usa inc.	3

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Cladribine	Cladribine	injection, solution, intravenous	42658-010ANDA
Dactinomycin	dactinomycin	injection, powder, lyophilized, for solution, intravenous	42658-008ANDA
Daunorubicin Hydrochloride	daunorubicin hydrochloride	injection, solution, intravenous	42658-019ANDA
Daunorubicin Hydrochloride	daunorubicin hydrochloride	injection, solution, intravenous	42658-021ANDA
Fludarabine Phosphate	Fludarabine Phosphate	injection, solution, intravenous	42658-024ANDA
IRBESARTAN	IRBESARTAN	tablet, film coated, oral	42658-121ANDA
IRBESARTAN	IRBESARTAN	tablet, film coated, oral	42658-122ANDA
IRBESARTAN	IRBESARTAN	tablet, film coated, oral	42658-123ANDA
Micafungin	Micafungin	injection, powder, for solution, intravenous	42658-022ANDA
Micafungin	Micafungin	injection, powder, for solution, intravenous	42658-023ANDA
PREDNISOLONE	PREDNISOLONE	tablet, oral	42658-160ANDA
Ticagrelor	Ticagrelor	tablet, film coated, oral	42658-115ANDA

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Enquiry

Common questions

Is Hisun Pharmaceuticals USA, Inc. FDA approved?: Hisun Pharmaceuticals USA, Inc. holds no registered establishment of its own; 12 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Hisun Pharmaceuticals USA, Inc. make?: 12 products are listed under Hisun Pharmaceuticals USA, Inc. in the openFDA NDC Directory, most often as injection, solution; tablet, film coated; injection, powder, for solution. 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.