Elite Laboratories, Inc.
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- United States
- Registered address
- 165\144\135 Ludlow Avenue, Northvale, New Jersey (NJ) 07647, United States (USA)
- Operations here
- labelmanufacture
- FDA identifiers
- FEI 3002644678 · DUNS 785398728
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-08-01
- VAIBioresearch Monitoring2020-03-13
- NAIDrug Quality Assurance2020-01-21
- NAIDrug Quality Assurance2018-02-02
- NAIDrug Quality Assurance2017-12-04
- VAIDrug Quality Assurance2017-04-24
- VAIPostmarket Surv. and Epidemiology2017-04-24
- OAIBioresearch Monitoring2016-02-02
- VAIDrug Quality Assurance2014-06-03
- VAIDrug Quality Assurance2012-08-14
- VAIDrug Quality Assurance2011-04-28
Drugs this plant is listed as making
14 distinct drugs across 45 products name this site in their FDA label.
- Acetaminophen and Codeine PhosphateElite Laboratories, Inc.
- dantrolene sodiumElite Laboratories, Inc.
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateBurel Pharmaceuticals, LLC
- Hydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.
- IsradipineElite Laboratories, Inc.
- LoxapineElite Laboratories, Inc.
- Methadone HydrochlorideElite Laboratories, Inc.
- Methotrexate Sodiumin shortageElite Laboratories, Inc.
- Naltrexone HydrochlorideElite Laboratories, Inc.
- Oxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.
- Phendimetrazine TartrateElite Laboratories, Inc
- Phentermine HydrochlorideElite Laboratories, Inc.
- RopiniroleElite Laboratories, Inc.
- Trimipramine MaleateElite Laboratories, Inc.
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.