Labeler · US market

Elite Laboratories, Inc

Elite Laboratories, Inc is a US drug labeler with US FDA registrations covering 16 drug concepts (16 currently active) across 81 packages.

ACTIVE — US

openFDA · updated weekly

Labeler codes64850

Active drugs16

Registrations53 active / 53

Packages81

Sole supplier of0 drugs

Portfolio16 drugs · US

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

Drug	Type	NDCs	Packages	Status
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate tablet	rx	7	21	SUPPLYING
Acetaminophen And Codeine Phosphate tablet	rx	3	9	SUPPLYING
Lisdexamfetamine Dimesylate capsule	rx	7	7	SUPPLYING
Oxycodone Hydrochloride And Acetaminophen tablet	rx	3	6	SUPPLYING
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate capsule, extended release	rx	6	6	SUPPLYING
Ropinirole tablet, extended release	rx	5	5	SUPPLYING
Hydrocodone Bitartrate And Acetaminophen tablet	rx	4	4	SUPPLYING
Isradipine capsule	rx	2	4	SUPPLYING
Loxapine capsule	rx	4	4	SUPPLYING
Trimipramine Maleate capsule	rx	3	3	SUPPLYING
Dantrolene Sodium capsule	rx	3	3	SUPPLYING
Methadone Hydrochloride tablet	rx	2	2	SUPPLYING
Naltrexone Hydrochloride tablet, film coated	rx	1	2	SUPPLYING
Phentermine Hydrochloride tablet	rx	1	2	SUPPLYING
Phendimetrazine Tartrate tablet	rx	1	2	SUPPLYING
Methotrexate Sodium tablet	rx	1	1	SUPPLYING

At a glance

TypeLabeler
Labeler codes64850
Filing names1
Drugs (active)16
Drugs (all time)16
US registrations53
Packages81

Recent events

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

Feb 11, 2026
RESOLVEDShortage resolved: Naltrexone Hydrochloride Tablet (Elite Laboratories, Inc.)
Feb 29, 2024
SHORTAGEDrug shortage: Naltrexone Hydrochloride Tablet (Elite Laboratories, Inc.)
Jul 14, 2023
SHORTAGEDrug shortage: Lisdexamfetamine Dimesylate Capsule (Elite Laboratories, Inc.)
Oct 12, 2022
SHORTAGEDrug shortage: Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (Elite Laboratories, Inc.)
Nov 13, 2017
RECALLRecall (Class III): Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Laboratories, Inc. Northvale, NJ 07…

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.