Drug company (FDA labeler)
Novel Laboratories, Inc.
NDC labeler code: 40032
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- FlucytosineAncobon · 2 products
- MisoprostolCytotec · 2 products
- Clobetasol propionateClobetasol Propionate (Emollient), Byqlovi, Tovet (Emollient Formulation) · 2 products
- Hydrocodone bitartrate and homatropine methylbromide2 products
- Polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloridePeg-3350 and Electrolytes, Golytely, PEG 3350 and Electrolytes · 1 product
- Potassium chlorideKlor-Con, Klor-Con M, Pokonza · 1 product
- DoxycyclineDoxy 100, Acticlate Cap, Doryx Mpc · 1 product
- Cevimeline hydrochlorideEvoxac · 1 product
- Trimethoprim1 product
- Nitrofurantoin1 product
- Oxycodone hydrochlorideOxycontin, Roxybond, Roxicodone · 1 product
- DesoximetasoneTopicort · 1 product
- DiclofenacZipsor, Lofena, Cambia · 1 product
- Fluocinonide1 product
- VoriconazoleVfend · 1 product
- LevonorgestrelKyleena, Skyla, Mirena · 1 product
- CarbidopaLodosyn · 1 product
- Sodium sulfate, potassium sulfate, magnesium sulfateSuprep Bowel Prep, Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Bowel Prep Kit · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| November 21, 2018 | ANDA210241 | Potassium chloride POTASSIUM CHLORIDE | Novel Labs Inc |
| May 4, 2018 | ANDA208841 | Clobetasol propionate CLOBETASOL PROPIONATE | Novel Labs Inc |
| October 20, 2017 | ANDA204763 | Carbidopa CARBIDOPA | Novel Labs Inc |
| September 6, 2017 | ANDA207558 | Doxycycline DOXYCYCLINE HYCLATE | Novel Labs Inc |
| July 21, 2017 | ANDA206003 | Fluocinonide FLUOCINONIDE | Novel Labs Inc |
| July 7, 2017 | ANDA204652 | Flucytosine FLUCYTOSINE | Novel Labs Inc |
| February 23, 2017 | ANDA202511 | Sodium sulfate, potassium sulfate, magnesium sulfate SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | Novel Labs Inc |
| February 13, 2017 | ANDA203535 | Hydrocodone bitartrate and homatropine methylbromide HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE | Novel Labs Inc |
| December 30, 2016 | ANDA204746 | Cevimeline hydrochloride CEVIMELINE HYDROCHLORIDE | Novel Labs Inc |
| May 31, 2016 | ANDA206799 | Voriconazole VORICONAZOLE | Novel Labs Inc |
| May 10, 2016 | ANDA206792 | Desoximetasone DESOXIMETASONE | Novel Labs Inc |
| December 9, 2015 | ANDA205878 | Diclofenac DICLOFENAC SODIUM | Novel Labs Inc |
| November 23, 2015 | ANDA206075 | Clobetasol propionate CLOBETASOL PROPIONATE | Novel Labs Inc |
| August 24, 2015 | ANDA204752 | Oxycodone hydrochloride OXYCODONE HYDROCHLORIDE | Novel Labs Inc |
| September 8, 2014 | ANDA201693 | Nitrofurantoin NITROFURANTOIN | Novel Labs Inc |
| February 22, 2013 | ANDA202508 | Levonorgestrel LEVONORGESTREL | Novel Labs Inc |
| July 25, 2012 | ANDA091667 | Misoprostol MISOPROSTOL | Novel Labs Inc |
| June 15, 2011 | ANDA091437 | Trimethoprim TRIMETHOPRIM | Novel Labs Inc |
| April 20, 2011 | ANDA091528 | Hydrocodone bitartrate and homatropine methylbromide HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE | Novel Labs Inc |
| June 1, 2009 | ANDA090231 | Polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride PEG 3350 AND ELECTROLYTES | Novel Labs Inc |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
No recall of these products (by NDC code) appears in the FDA enforcement reports.
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
- All drug companiesA to Z
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026