Labeler · US market

Trigen Laboratories, LLC

Trigen Laboratories, LLC is a US drug labeler with US FDA registrations covering 9 drug concepts (8 currently active) across 42 packages. It is currently the only active US supplier of 1 drug.

ACTIVE — US

openFDA · updated weekly

Labeler codes13811

Active drugs8

Registrations30 active / 32

Packages42

Sole supplier of1 drugs

Portfolio9 drugs · US

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

Drug	Type	NDCs	Packages	Status
Phenobarbital tablet	rx	8	16	SUPPLYING
Methylphenidate Hydrochloride tablet, extended release	rx	7	8	SUPPLYING
Estradiol gel	rx	5	5	SUPPLYING
Hydromorphone Hydrochloride tablet, extended release	rx	4	4	SUPPLYING
Tramadol Hydrochloride capsule	rx	3	3	SUPPLYING
Lacosamide injection	rx	1	1	SUPPLYING
Phenobarbital elixir	rx	1	1	SUPPLYING
Nitrofurantoin capsule	rx	1	1	SUPPLYING
Venlafaxine Hydrochloride tablet, extended release	rx	2	3	DISCONTINUED

Sole US supplier

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

Tramadol Hydrochloriderx

At a glance

TypeLabeler
Labeler codes13811
Filing names1
Drugs (active)8
Drugs (all time)9
US registrations32
Packages42

Recent events

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

Jun 17, 2024
RECALLRecall (Class II): Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen…
Jul 26, 2023
SHORTAGEDrug shortage: Methylphenidate Hydrochloride Tablet, Extended Release (Trigen Laboratories, LLC)
Feb 28, 2018
RECALLRecall (Class III): Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC…
Dec 18, 2017
RECALLRecall (Class III): Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC…
Dec 18, 2017
RECALLRecall (Class III): Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LL…
Apr 17, 2014
RECALLRecall (Class III): Triveen - PRx RNF Capsules, 30-count bottles, Rx only; Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ 088…

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; figures cover the entity across all its filing names.