Labeler · US market

Janssen Pharmaceuticals, Inc.

Janssen Pharmaceuticals, Inc. is a US drug labeler with US FDA registrations covering 23 drug concepts (19 currently active) across 91 packages. It is currently the only active US supplier of 7 drugs. The company files with FDA under 2 name variants, merged into this profile.

Also files as: Janssen Pharmaceutical, Inc.

ACTIVE — US

openFDA · updated weekly

Labeler codes50458

Active drugs19

Registrations60 active / 65

Packages91

Sole supplier of7 drugs

Portfolio23 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Rivaroxaban tablet, film coated	rx	4	17	SUPPLYING
Canagliflozin tablet, film coated	rx	2	10	SUPPLYING
Risperidone tablet	rx	5	9	SUPPLYING
Paliperidone Palmitate injection	rx	5	7	SUPPLYING
Paliperidone tablet, extended release	rx	4	6	SUPPLYING
Paliperidone Palmitate injection, suspension, extended release	rx	6	6	SUPPLYING
Methylphenidate Hydrochloride tablet, extended release	rx	4	4	SUPPLYING
Risperidone kit	rx	4	4	SUPPLYING
Canagliflozin And Metformin Hydrochloride tablet, film coated	rx	4	4	SUPPLYING
Topiramate tablet, coated	rx	4	4	SUPPLYING
Canagliflozin And Metformin Hydrochloride tablet, film coated, extended release	rx	4	4	SUPPLYING
Risperidone solution	rx	2	2	SUPPLYING
Esketamine Hydrochloride solution	rx	1	2	SUPPLYING
Topiramate capsule, coated pellets	rx	2	2	SUPPLYING
Rivaroxaban kit	rx	1	2	SUPPLYING
Mebendazole tablet, chewable	rx	1	1	SUPPLYING
Pentosan Polysulfate Sodium capsule, gelatin coated	rx	1	1	SUPPLYING
Rivaroxaban Granule for suspension	rx	1	1	SUPPLYING
Risperidone tablet, orally disintegrating	rx	5	0	SUPPLYING
Haloperidol Decanoate injection	rx	2	2	DISCONTINUED
Itraconazole capsule	rx	1	2	DISCONTINUED
Ponesimod tablet, film coated	rx	1	1	DISCONTINUED
Ponesimod kit	rx	1	0	DISCONTINUED

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

At a glance

TypeLabeler
Labeler codes50458
Filing names2
Drugs (active)19
Drugs (all time)23
US registrations65
Packages91

Recent events

Shortages, recalls, and registration changes across all filing names.

Feb 27, 2026
RESOLVEDShortage resolved: Itraconazole Capsule (Janssen Pharmaceuticals)
Feb 27, 2026
SHORTAGEDrug shortage: Itraconazole Capsule (Janssen Pharmaceuticals)
Jul 26, 2023
SHORTAGEDrug shortage: Methylphenidate Hydrochloride Tablet, Extended Release (Janssen Pharmaceuticals)
Oct 23, 2018
RECALLRecall (Class II): Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28-Day Regimen per pouch (NDC 50458-176-28),…
Oct 23, 2018
RECALLRecall (Class II): Ortho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035, 28-Day Regi…
Apr 29, 2015
RECALLRecall (Class II): Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister (21 active tablets and 7 plac…
Sep 11, 2013
RECALLRecall (Class II): Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, N…

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile (see “Also files as” above); figures cover the entity across all its filing names.