Labeler · US market

Zyla Life Sciences US LLC

Zyla Life Sciences US LLC is a US drug labeler with US FDA registrations covering 4 drug concepts (4 currently active) across 6 packages. It is currently the only active US supplier of 1 drug. The company files with FDA under 2 name variants, merged into this profile.

Also files as: Zyla Life Sciences US Inc.

ACTIVE — US

openFDA · updated weekly

Labeler codes69344

Active drugs4

Registrations5 active / 5

Packages6

Sole supplier of1 drugs

Portfolio4 drugs · US

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

Drug	Type	NDCs	Packages	Status
Oxycodone Hydrochloride tablet	rx	2	2	SUPPLYING
Ketorolac Tromethamine spray, metered	rx	1	2	SUPPLYING
Indomethacin suppository	rx	1	1	SUPPLYING
Indomethacin suspension	rx	1	1	SUPPLYING

Sole US supplier

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

Ketorolac Tromethaminerx

At a glance

TypeLabeler
Labeler codes69344
Filing names2
Drugs (active)4
Drugs (all time)4
US registrations5
Packages6

Recent events

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

Oct 20, 2023
RECALLRecall (Class III): Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc…

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.