Labeler · US market

Alvogen Inc.

Alvogen Inc. is a US drug labeler with US FDA registrations covering 29 drug concepts (25 currently active) across 112 packages. It is currently the only active US supplier of 6 drugs. The company files with FDA under 2 name variants, merged into this profile.

Also files as: ALVOGEN

ACTIVE — US

openFDA · updated weekly

Labeler codes47781

Active drugs25

Registrations78 active / 86

Packages112

Sole supplier of6 drugs

Portfolio29 drugs · US

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

Drug	Type	NDCs	Packages	Status
Levothyroxine Sodium tablet	rx	12	24	SUPPLYING
Lenalidomide capsule	rx	6	12	SUPPLYING
Hydrocodone Bitartrate tablet, extended release	rx	7	7	SUPPLYING
Lisdexamfetamine Dimesylate capsule	rx	7	7	SUPPLYING
Oxycodone And Acetaminophen tablet	rx	3	7	SUPPLYING
Oxycodone Hydrochloride tablet	rx	3	6	SUPPLYING
Hydrocodone Bitartrate capsule, extended release	rx	6	6	SUPPLYING
Fentanyl patch	rx	5	5	SUPPLYING
Buprenorphine And Naloxone film	rx	4	4	SUPPLYING
Dexamethasone tablet	rx	2	3	SUPPLYING
Nitrofurantoin (Macrocrystals) capsule	rx	3	3	SUPPLYING
Oseltamivir Phosphate capsule	rx	3	3	SUPPLYING
Teriparatide injection, solution	rx	2	2	SUPPLYING
Rasagiline tablet	rx	2	2	SUPPLYING
Testosterone Cypionate injection, solution	rx	2	2	SUPPLYING
Sertraline Hydrochloride capsule	rx	2	2	SUPPLYING
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 15 Mg,cll tablet	rx	1	1	SUPPLYING
Oseltamivir Phosphate powder, for suspension	rx	1	1	SUPPLYING
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 20 Mg,cll tablet	rx	1	1	SUPPLYING
Disulfiram tablet	rx	1	1	SUPPLYING
Pyridostigmine Bromide tablet, extended release	rx	1	1	SUPPLYING
Nitrofurantoin Monohydrate/Macrocrystalline capsule	rx	1	1	SUPPLYING
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 5 Mg,cll tablet	rx	1	1	SUPPLYING
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 10 Mg,cll tablet	rx	1	1	SUPPLYING
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 30 Mg,cll tablet	rx	1	1	SUPPLYING
Buprenorphine patch, extended release	rx	4	4	DISCONTINUED
Naproxen Sodium tablet, film coated, extended release	rx	2	2	DISCONTINUED
Methenamine Hippurate tablet	rx	1	1	DISCONTINUED
Estradiol cream	rx	1	1	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 codes47781
Filing names2
Drugs (active)25
Drugs (all time)29
US registrations86
Packages112

Recent events

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

Dec 31, 2025
RECALLRecall (Class II): Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYD, Inc., Shenandoah,…
Jan 31, 2025
RECALLRecall (Class I): Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed…
Jul 14, 2023
SHORTAGEDrug shortage: Lisdexamfetamine Dimesylate Capsule (Alvogen)
Feb 6, 2023
RECALLRecall (Class II): Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, …
Oct 12, 2022
SHORTAGEDrug shortage: Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (Alvogen)
Feb 26, 2021
RECALLRecall (Class II): Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alv…
Jul 24, 2019
RECALLRecall (Class II): Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pin…
Jul 24, 2019
RECALLRecall (Class II): Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. by: Norwich Pharmaceuticals, Inc. Norwic…

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.