Is OPKO Pharmaceuticals, LLC FDA approved?

OPKO Pharmaceuticals, LLC 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 OPKO Pharmaceuticals, LLC make?

8 products are listed under OPKO Pharmaceuticals, LLC in the openFDA NDC Directory, most often as capsule; capsule, extended release. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

OPKO Pharmaceuticals, LLC

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

Request a quote Claim this profile

Registered sites: 0
Active NDC listings: 8
Labeller names: 2
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

8 active NDC listings: 8 human prescription drug. By marketing category: ANDA 6, NDA 2.

Dosage form	NDCs
capsule	6
capsule, extended release	2

Route	NDCs
oral	8

Labeller name on the listing	NDCs
opko pharmaceuticals, llc	6
opko pharmaceuticals llc	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Cyclophosphamide	CYCLOPHOSPHAMIDE	capsule, oral	70301-2013ANDA
Cyclophosphamide	CYCLOPHOSPHAMIDE	capsule, oral	70301-2015ANDA
Rayaldee	calcifediol	capsule, extended release, oral	70301-1001NDA
Rayaldee	calcifediol	capsule, extended release, oral	70301-1002NDA
Temozolomide	TEMOZOLOMIDE	capsule, oral	70301-2005ANDA
Temozolomide	TEMOZOLOMIDE	capsule, oral	70301-2007ANDA
Temozolomide	TEMOZOLOMIDE	capsule, oral	70301-2009ANDA
Temozolomide	TEMOZOLOMIDE	capsule, oral	70301-2011ANDA

Compare

Other companies listing temozolomide

Pacific Medical Industries Ltd4 sites · 41 NDC
SHILPA PHARMA LIFESCIENCES LIMITED2 sites · 40 NDC
Camber Pharmaceuticals, Inc.1 site · 640 NDC
Valary Lab Private Limited1 site · 32 NDC

Enquiry

Common questions

Is OPKO Pharmaceuticals, LLC FDA approved?: OPKO Pharmaceuticals, LLC 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 OPKO Pharmaceuticals, LLC make?: 8 products are listed under OPKO Pharmaceuticals, LLC in the openFDA NDC Directory, most often as capsule; capsule, extended release. 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.