Azurity Pharmaceuticals, Inc.
NDC labeler codes: 24338, 52652, 60631
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
- DextroamphetamineZenzedi, Xelstrym, Dexedrine Spansule · 7 products
- Lisdexamfetamine dimesylateVyvanse, Arynta · 5 products
- LomustineGleostine · 3 products
- Telmisartan, amlodipine and indapamideWidaplik · 3 products
- Testosterone cypionateDepo-Testosterone, Azmiro · 2 products
- NilotinibTasigna, Danziten, Cavhanza · 2 products
- FerumoxytolFerabright · 2 products
- Sodium sulfate, potassium sulfate, magnesium sulfateSuprep Bowel Prep, Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Bowel Prep Kit · 2 products
- NimodipineNymalize · 2 products
- Azilsartan kamedoxomilAzilsartan Medoxomil, Edarbi · 2 products
- AmphetamineAdzenys Xr-Odt, Dyanavel XR, Evekeo · 2 products
- ClonidineClonidine Transdermal System, Catapres-Tts-1, Clonidine Transdermal System Usp, 0.1 Mg/Day · 1 product
- Enalapril maleateVasotec, Epaned · 1 product
- SitagliptinJanuvia, Zituvio, Brynovin · 1 product
- CarmustineGliadel · 1 product
- Bendamustine hydrochlorideTreanda, Vivimusta, Belrapzo · 1 product
- MethotrexateRasuvo, Otrexup, Trexall · 1 product
- TopiramateTopamax, Qudexy XR, Trokendi XR · 1 product
- MeloxicamZybic, Xifyrm, Qamzova · 1 product
- LisinoprilZestril, Qbrelis · 1 product
- Mycophenolate mofetilCellcept, Myhibbin · 1 product
- ZonisamideZonegran, Zonisade · 1 product
- Sodium sulfate, magnesium sulfate, and potassium chlorideSutab · 1 product
- Sotalol hydrochlorideBetapace, Sotalol Hydrochloride Af, Betapace Af · 1 product
- Polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloridePeg-3350 and Electrolytes, Golytely, PEG 3350 and Electrolytes · 1 product
- Amlodipine (amlodipine benzoate)Katerzia · 1 product
- BaclofenGablofen, Lyvispah, Baclofen (Intrathecal) · 1 product
- Hydralazine hydrochloride and isosorbide dinitrateBidil · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Show the other 3 applications
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| September 23, 1996 | NDA020637 | Carmustine GLIADEL | Azurity |
| July 13, 1984 | NDA019011 | Polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride GOLYTELY | Azurity |
| August 4, 1976 | NDA017588 | Lomustine GLEOSTINE | Azurity |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2023
-
December 8, 2023 · Class III · Terminated · D-0213-2024 · Topiramate
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
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