Organon LLC

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3017425145	3017425145	Organon LLC	1	N	2026-01-01	30 Hudson Street Floor 33 Jersey City NJ US 07302

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00378206129017	FOLLISTIM AQ CARTRIDGE 300IU - 1044615	+1(844)674-3200	dpoc.us@organon.com
00378206129598	FOLLISTIM AQ CARTRIDGE 300IU SAM - 1044801	+1(844)674-3200	dpoc.us@organon.com
00378206130013	FOLLISTIM AQ CARTRIDGE 600IU - 1044616	+1(844)674-3200	dpoc.us@organon.com
00378206130594	FOLLISTIM AQ CARTRIDGE 600IU SAM - 1044800	+1(844)674-3200	dpoc.us@organon.com
00378206131010	FOLLISTIM AQ CARTRIDGE 900IU - 1044617	+1(844)674-3200	dpoc.us@organon.com
00840164519440	FOLLISTIM PEN STARTER KIT - 1044942	+1(844)674-3200	dpoc.us@organon.com
00840164519457	FOLLISTIM PEN STARTER KIT SAM - 1044943	+1(844)674-3200	dpoc.us@organon.com
10378206189018	XACIATO - 1048228	+1(844)674-3200	dpoc.us@organon.com

organon.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
279176	1479191288	K212757	Jada System	OQY	2021-09-30
279176	1757936486	K201199	Jada System	OQY	2020-08-28
279176	1785667387

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
OQY	2	2021-09-30

NDC#

ASMANEX HFA

Organon LLC

MOMETASONE FUROATE

ASMANEX HFA

Organon LLC

MOMETASONE FUROATE

ASMANEX HFA

Organon LLC

MOMETASONE FUROATE

ASMANEX

Organon LLC

Mometasone Furoate

ASMANEX

Organon LLC

Mometasone Furoate

CELESTONE SOLUSPAN

Organon LLC

Betamethasone Acetate and Betamethasone Sodium Phosphate

Clarinex

Organon LLC

Desloratadine

CLARINEX-D 12 HOUR

Organon LLC

desloratadine and pseudoephedrine sulfate

COZAAR

Organon LLC

losartan potassium

COZAAR

Organon LLC

losartan potassium

COZAAR

Organon LLC

losartan potassium

DIPROLENE

Organon LLC

betamethasone dipropionate

Dulera

Organon LLC

mometasone furoate and formoterol fumarate dihydrate

Dulera

Organon LLC

mometasone furoate and formoterol fumarate dihydrate

Dulera

Organon LLC

mometasone furoate and formoterol fumarate dihydrate

Follistim AQ

Organon LLC

follitropin

Follistim AQ

Organon LLC

follitropin

Follistim AQ

Organon LLC

follitropin

FOSAMAX

Organon LLC

alendronate sodium

FOSAMAX PLUS D

Organon LLC

ALENDRONATE SODIUM and CHOLECALCIFEROL

FOSAMAX PLUS D

Organon LLC

ALENDRONATE SODIUM and CHOLECALCIFEROL

Ganirelix Acetate

Organon LLC

Ganirelix Acetate

HYZAAR

Organon LLC

losartan potassium and hydrochlorothiazide

HYZAAR

Organon LLC

losartan potassium and hydrochlorothiazide

HYZAAR

Organon LLC

losartan potassium and hydrochlorothiazide

MAXALT

Organon LLC

rizatriptan benzoate

MAXALT-MLT

Organon LLC

rizatriptan benzoate

Nexplanon

Organon LLC

etonogestrel

NuvaRing

Organon LLC

etonogestrel and ethinyl estradiol

Ontruzant

Organon LLC

trastuzumab

Ontruzant

Organon LLC

Ontruzant

Pregnyl

Organon LLC

CHORIOGONADOTROPIN ALFA

PROPECIA

Organon LLC

finasteride

PROSCAR

Organon LLC

FINASTERIDE

REMERONSOLTAB

Organon LLC

MIRTAZAPINE

REMERONSOLTAB

Organon LLC

MIRTAZAPINE

REMERONSOLTAB

Organon LLC

MIRTAZAPINE

REMERON

Organon LLC

MIRTAZAPINE

REMERON

Organon LLC

MIRTAZAPINE

Renflexis

Organon LLC

infliximab

69 records. Showing 1-40. Next

PMA#

HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST

1990-03-21

ORGANON TEKNIKA CORP.

HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM

1990-03-21

ORGANON TEKNIKA CORP.

9EPANOSTIKA(TM) ANTI-HAV IGM

1990-03-21

ORGANON TEKNIKA CORP.

AUTOBAC MIC TEST SYSTEM

1990-01-22

ORGANON TEKNIKA CORP.

AUTOBAC MIC TEST SYSTEM

1989-12-07

ORGANON TEKNIKA CORP.

AUTOBAC MIC TEST SYSTEM

1989-06-13

ORGANON TEKNIKA CORP.

HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM

1989-02-06

ORGANON TEKNIKA CORP.

AUTOBAC MIC TEST SYSTEM

1988-12-28

ORGANON TEKNIKA CORP.

AUTOBAC MIC TEST SYSTEM

1988-10-18

ORGANON TEKNIKA CORP.

AUTOBAC MIC TEST SYSTEM

1988-09-26

ORGANON TEKNIKA CORP.

AUTOBAC MIC TEST SYSTEM

1988-08-22

ORGANON TEKNIKA CORP.

AUTOBAC MIC TEST SYSTEM

1988-07-21

ORGANON TEKNIKA CORP.

AUTOBAC MIC TEST SYSTEM

1988-07-20

ORGANON TEKNIKA CORP.

AUTOBAC MIC TEST SYSTEM

1988-07-07

ORGANON TEKNIKA CORP.

AUTOBAC MIC TEST SYSTEM

1988-06-22

ORGANON TEKNIKA CORP.

AUTOBAC MIC TEST SYSTEM

1988-04-20

ORGANON TEKNIKA CORP.

AUTOBAC MIC TEST SYSTEM

1988-04-12

ORGANON TEKNIKA CORP.

AMIKACIN ELUTION DISK FOR AUTOBAC

1988-04-05

ORGANON TEKNIKA CORP.

AUTOBAC MIC TEST SYSTEM

1988-04-05

ORGANON TEKNIKA CORP.

AMIKACIN ELUTION DISK FOR AUTOBAC

1987-08-10

ORGANON TEKNIKA CORP.

AMIKACIN ELUTION DISK FOR AUTOBAC

1987-08-10

ORGANON TEKNIKA CORP.

HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST

1986-05-14

ORGANON TEKNIKA CORP.

AUTOBAC MIC TEST SYSTEM

1986-03-17

ORGANON TEKNIKA CORP.

CURESIS PLASMA SEPARATOR

1985-12-06

ORGANON TEKNIKA CORP.

AUTOBAC MIC TEST SYSTEM

1985-11-27

ORGANON TEKNIKA CORP.

AUTOBAC MIC TEST SYSTEM

1985-11-21

ORGANON TEKNIKA CORP.

AMIKACIN ELUTION DISK FOR AUTOBAC

1985-08-22

ORGANON TEKNIKA CORP.

AMIKACIN ELUTION DISK FOR AUTOBAC

1985-03-26

ORGANON TEKNIKA CORP.

CURESIS PLASMA SEPARATOR

1985-02-12

ORGANON TEKNIKA CORP.

CURESIS PLASMA SEPARATOR

1984-09-19

ORGANON TEKNIKA CORP.

AUTOBAC MIC TEST SYSTEM

1984-09-13

ORGANON TEKNIKA CORP.

AMIKACIN ELUTION DISK FOR AUTOBAC

1984-07-20

ORGANON TEKNIKA CORP.

AMIKACIN ELUTION DISK FOR AUTOBAC

1984-07-20

ORGANON TEKNIKA CORP.

AMIKACIN ELUTION DISK FOR AUTOBAC

1984-06-08

ORGANON TEKNIKA CORP.

AMIKACIN ELUTION DISK FOR AUTOBAC

1984-04-10

ORGANON TEKNIKA CORP.

AMIKACIN ELUTION DISK FOR AUTOBAC

1984-03-15

ORGANON TEKNIKA CORP.

AMIKACIN ELUTION DISK FOR AUTOBAC

1984-03-15

ORGANON TEKNIKA CORP.

AUTOBAC MIC TEST SYSTEM

1984-02-15

ORGANON TEKNIKA CORP.

AUTOBAC MIC TEST SYSTEM

1983-10-18

ORGANON TEKNIKA CORP.

AUTOBAC MIC TEST SYSTEM

1983-07-18

ORGANON TEKNIKA CORP.

58 records. Showing 1-40. Next

PMN#

BACT/ALERT CSR

2000-10-20

ORGANON TEKNIKA CORP.

MDA D-DIMER

2000-06-07

ORGANON TEKNIKA CORP.

BACT/ALERT MB CULTURE BOTTLE

2000-03-02

ORGANON TEKNIKA CORP.

BACT/ALERT SV

2000-02-10

ORGANON TEKNIKA CORP.

BACT/ALERT SA

1999-12-15

ORGANON TEKNIKA CORP.

BACT/ALERT MP PROCESS BOTTLE

1999-12-14

ORGANON TEKNIKA CORP.

BACT/ALERT SN

1999-12-14

ORGANON TEKNIKA CORP.

BACT/ALERT FN

1999-09-24

ORGANON TEKNIKA CORP.

NUCLISENS CMV PP67

1999-09-15

ORGANON TEKNIKA CORP.

BACT/ALERT PF

1999-09-03

ORGANON TEKNIKA CORP.

BACTALERT FA

1999-09-03

ORGANON TEKNIKA CORP.

TOF-WATCH S

1999-08-30

ORGANON TEKNIKA CORP.

TOF-WATCH SX

1999-08-30

ORGANON TEKNIKA CORP.

COAG-A-MATE MAX

1999-06-01

ORGANON TEKNIKA CORP.

MB/BACT BLOOD CULTURE BOTTLE

1999-01-13

ORGANON TEKNIKA CORP.

MB/BACT BLOOD CULTURE BOTTLE

1998-08-18

ORGANON TEKNIKA CORP.

BACT/ALERT 3D MICROBIAL DETECTION SYSTEM

1998-07-24

ORGANON TEKNIKA CORP.

MDA D-DIMER

1998-04-16

ORGANON TEKNIKA CORP.

MDA SIMPLASTIN HTF

1998-02-24

ORGANON TEKNIKA CORP.

TOF-WATCH

1997-12-16

ORGANON TEKNIKA CORP.

BACT/ALERT FAN CULTURE BOTTLES

1997-12-02

ORGANON TEKNIKA CORP.

BACT/ALERT CULTURE BOTTLES

1997-11-17

ORGANON TEKNIKA CORP.

MDA HEPARIN ANTI-X ASSAY

1997-03-18

ORGANON TEKNIKA CORP.

THROMBONOSTIKA F1.2

1997-03-18

ORGANON TEKNIKA CORP.

COAG-A-MATE MTX

1997-01-22

ORGANON TEKNIKA CORP.

MB/BACT MYCROBACTERIA DETECTION SYSTEM

1996-07-22

ORGANON TEKNIKA CORP.

AURAFLEX TESTOSTERONE CALIBRATOR PACK

1995-11-14

ORGANON TEKNIKA CORP.

MDA SIMPLASTIN LS

1995-10-06

ORGANON TEKNIKA CORP.

AURAFLEX TG-AB AND TPO-AB

1995-08-25

ORGANON TEKNIKA CORP.

AURAFLEX TPO-AB

1995-08-25

ORGANON TEKNIKA CORP.

AURAFLEX B2-MICROGLOBULIN

1995-06-20

ORGANON TEKNIKA CORP.

RECONSTITUTION ACCESSOREIS

1995-05-26

ORGANON, INC.

AURAFLEX PROGESTERONE 150TEST PACK

1995-05-08

ORGANON TEKNIKA CORP.

AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK

1995-05-02

ORGANON TEKNIKA CORP.

AURAFLEX(R) ESTRADIOL

1995-04-03

ORGANON TEKNIKA CORP.

AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1

1995-03-21

ORGANON TEKNIKA CORP.

AURAFLEX HCG

1995-03-20

ORGANON TEKNIKA CORP.

MICROPLATE PROCESSOR 3000

1995-03-03

ORGANON TEKNIKA CORP.

AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK

1995-02-22

ORGANON TEKNIKA CORP.

BACT/ALERT FAN CULTURE BOTTLE

1995-02-17

ORGANON TEKNIKA CORP.

164 records. Showing 1-40. Next

Applications#

089624

ORGANON USA INC

087535

ORGANON USA INC

087014

ORGANON USA INC

086750

ORGANON USA INC

086562

ORGANON USA INC

080997

ORGANON USA INC

022225

ORGANON SUB MERCK

021529

ORGANON USA INC

021273

ORGANON USA INC

021211

ORGANON USA INC

021208

ORGANON USA INC

021187

ORGANON SUB MERCK

021057

ORGANON USA INC

020984

ORGANON USA INC

020582

ORGANON USA INC

020580

ORGANON USA INC

020415

ORGANON USA INC

020328

ORGANON USA INC

020214

ORGANON USA INC

020071

ORGANON USA INC

019638

ORGANON USA INC

018776

ORGANON USA INC

018312

ORGANON USA INC

017692

ORGANON USA INC

017015

ORGANON USA INC

014006

ORGANON USA INC

014005

ORGANON USA INC

011891

ORGANON USA INC

011228

ORGANON USA INC

005490

ORGANON USA INC

001104

ORGANON USA INC

000552

ORGANON USA INC

GUDID#

XACIATO - 1048228

Organon LLC

2024-09-13

FOLLISTIM PEN STARTER KIT - 1044942

Organon LLC

2024-01-01

FOLLISTIM PEN STARTER KIT SAM - 1044943

Organon LLC

2024-01-01

FOLLISTIM AQ CARTRIDGE 300IU - 1044615

Organon LLC

2024-01-01

FOLLISTIM AQ CARTRIDGE 300IU SAM - 1044801

Organon LLC

2024-01-01

FOLLISTIM AQ CARTRIDGE 600IU - 1044616

Organon LLC

2024-01-01

FOLLISTIM AQ CARTRIDGE 600IU SAM - 1044800

Organon LLC

2024-01-01

FOLLISTIM AQ CARTRIDGE 900IU - 1044617

Organon LLC

2024-01-01

FOLLISTIM AQ CARTRIDGE 300IU - 1044615

Organon LLC

2024-01-01

FOLLISTIM AQ CARTRIDGE 300IU SAM - 1044801

Organon LLC

2024-01-01

FOLLISTIM AQ CARTRIDGE 600IU - 1044616

Organon LLC

2024-01-01

FOLLISTIM AQ CARTRIDGE 600IU SAM - 1044800

Organon LLC

2024-01-01

FOLLISTIM AQ CARTRIDGE 900IU - 1044617

Organon LLC

2024-01-01

FOLLISTIM PEN STARTER KIT - 1044942

Organon LLC

2024-01-01

FOLLISTIM PEN STARTER KIT SAM - 1044943

Organon LLC

2024-01-01

JADA System - Vacuum-induced Hemorrhage Control System

Organon LLC

2023-02-15

JADA System - Vacuum-induced Hemorrhage Control System

Organon LLC

2023-02-15