Labeler · US market

Noven Therapeutics, LLC

Noven Therapeutics, LLC is a US drug labeler with US FDA registrations covering 5 drug concepts (5 currently active) across 26 packages. It is currently the only active US supplier of 3 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes68968

Active drugs5

Registrations23 active / 23

Packages26

Sole supplier of3 drugs

Portfolio5 drugs · US

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

Drug	Type	NDCs	Packages	Status
Estradiol film, extended release	rx	10	10	SUPPLYING
Asenapine film, extended release	rx	3	6	SUPPLYING
Methylphenidate patch	rx	4	4	SUPPLYING
Dextroamphetamine patch, extended release	rx	4	4	SUPPLYING
Estradiol/Norethindrone Acetate Transdermal System patch, extended release	rx	2	2	SUPPLYING

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 codes68968
Filing names1
Drugs (active)5
Drugs (all time)5
US registrations23
Packages26

Recent events

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

Oct 31, 2024
RECALLRecall (Class II): Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal …
Mar 10, 2023
RECALLRecall (Class II): Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics,…
Mar 10, 2023
RECALLRecall (Class II): Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics,…
Mar 10, 2023
RECALLRecall (Class II): Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics…
Mar 10, 2023
RECALLRecall (Class II): Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics…
Nov 16, 2022
RECALLRecall (Class II): Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, M…
Jun 24, 2022
RECALLRecall (Class II): Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Ma…
May 6, 2022
RECALLRecall (Class II): Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Ma…

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.