Manufacturing facility
Novel 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
- 400 Campus Drive, Somerset, New Jersey (NJ) 08873, United States (USA)
- Operations here
- analysismanufacturepack
- FDA identifiers
- FEI 3006271438 · DUNS 793518643
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2026-04-17
- NAIDrug Quality Assurance2024-05-17
- VAIDrug Quality Assurance2023-01-13
- VAIDrug Quality Assurance2022-03-30
- OAIDrug Quality Assurance2020-11-05
- VAIBioresearch Monitoring2018-11-08
- VAIDrug Quality Assurance2018-02-23
- VAIDrug Quality Assurance2017-08-08
- NAIDrug Quality Assurance2017-02-14
- NAIDrug Quality Assurance2015-11-17
- NAIBioresearch Monitoring2015-01-22
- VAIDrug Quality Assurance2014-06-24
- VAIDrug Quality Assurance2013-08-26
- VAIDrug Quality Assurance2011-06-29
- VAIDrug Quality Assurance2010-03-05
Drugs this plant is listed as making
52 distinct drugs across 110 products name this site in their FDA label.
- Amlodipine and ValsartanLupin Pharmaceuticals,Inc.
- brivaracetamLupin Pharmaceuticals, Inc.
- CarbidopaLupin Pharmaceuticals,Inc.
- cevimeline hydrochlorideNovel Laboratories, Inc.
- clobetasol propionateNovel Laboratories, Inc.
- CyanocobalaminLupin Pharmaceuticals,Inc.
- desoximetasoneNovel Laboratories, Inc.
- Dexmethylphenidate HydrochlorideLupin Pharmaceuticals,Inc.
- dextroamphetamine sulfateLupin Pharmaceuticals,Inc.
- DiazepamLupin Pharmaceuticals,Inc.
- Diclofenac SodiumNovel Laboratories, Inc.
- doxycyclineLupin Pharmaceuticals,Inc.
- Doxycycline HyclateNovel Laboratories, Inc.
- FamotidineLupin Pharmaceuticals,Inc.
- FlucytosineNovel Laboratories, Inc.
- Fluocinolone AcetonideLupin Pharmaceuticals,Inc.
- FluocinonideLupin Pharmaceuticals,Inc.
- Hydrocodone Bitartrate and AcetaminophenLupin Pharmaceuticals,Inc.
- Hydrocodone Bitartrate and Homatropine MethylbromideNovel Laboratories, Inc.
- LevonorgestrelNovel Laboratories, Inc.
- Methylergonovine maleateLupin Pharmaceuticals,Inc.
- Methylphenidate Hydrochloridein shortageLupin Pharmaceuticals,Inc.
- Metoclopramide HydrochlorideLupin Pharmaceuticals,Inc.
- MisoprostolNovel Laboratories, Inc.
- Morphine Sulfatein shortageLupin Pharmaceuticals,Inc.
- NitrofurantoinLupin Pharmaceuticals,Inc.
- Nitrofurantoin macrocrystalsLupin Pharmaceuticals,Inc.
- Orphenadrine CitrateLupin Pharmaceuticals, Inc.
- Oxycodone and AcetaminophenLupin Pharmaceuticals,Inc.
- Oxycodone HydrochlorideLupin Pharmaceuticals,Inc.
- Peg-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate And Ascorbic AcidTeva Pharmaceuticals USA, Inc.
- pentazocine hydrochloride and naloxone hydrochlorideLupin Pharmaceuticals,Inc.
- Phenelzine SulfateLupin Pharmaceuticals,Inc.
- Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride and Bisacodyl Delayed-release TabletLupin Pharmaceuticals, Inc.
- Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Ascorbic Acid, Sodium AscorbateSalix Pharmaceuticals, Inc.
- polyethylene glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic AcidOceanside Pharmaceuticals
- Polyethylene Glycol-3350 And ElectrolytesNovel Laboratories, Inc.
- polyethylene glycol-3350 and electrolytes with Flavor PackLupin Pharmaceuticals,Inc.
- polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonateLupin Pharmaceuticals,Inc.
- Potassium ChlorideLupin Pharmaceuticals,Inc.
- Quinapril HCL and HydrochlorothiazideLupin Pharmaceuticals,Inc.
- sodium sulfate, potassium sulfate, magnesium sulfateLupin Pharmaceuticals, Inc.
- TinidazoleLupin Pharmaceuticals,Inc.
- Trimethobenzamide HydrochlorideLupin Pharmaceuticals,Inc.
- TrimethoprimNovel Laboratories, Inc.
- voriconazoleLupin Pharmaceuticals,Inc.
- zolpidem tartrateLupin Pharmaceuticals,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.