Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)
NDC labeler codes: 24338, 53451, 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
- Erythromycin ethylsuccinateEry-Ped, E.E.S 400, E.E.S · 6 products
- Azilsartan kamedoxomil and chlorthalidoneEdarbyclor · 2 products
- Gabapentin enacarbilHorizant · 2 products
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.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| December 20, 2011 | NDA202331 | Azilsartan kamedoxomil and chlorthalidone EDARBYCLOR | Azurity |
| April 6, 2011 | NDA022399 | Gabapentin enacarbil HORIZANT | Azurity |
| August 12, 1982 | ANDA061905 | Erythromycin ethylsuccinate E.E.S. 400 | Pharmobedient |
| March 3, 1975 | ANDA061904 | Erythromycin ethylsuccinate ERYTHROMYCIN ETHYLSUCCINATE | Carnegie |
| April 2, 1965 | NDA050207 | Erythromycin ethylsuccinate E.E.S., ERYPED | Carnegie |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2024
-
January 4, 2024 · Class I · Terminated · D-0323-2024 · Dextroamphetamine
Labeling: Label Mix-up
Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, LLC., Atlanta, Georgia, 30328, NDC 24338-856-03
2021
-
March 15, 2021 · Class II · Terminated · D-0429-2021 · Azilsartan kamedoxomil
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufactured for: arbor Pharmaceuticals Atlanta, GA 30328
-
March 15, 2021 · Class II · Terminated · D-0431-2021 · Azilsartan kamedoxomil and chlorthalidone
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/25 mg *Each tablet contains: 42.68 mg azilsartan kamedoxomil (equivalent to 40 mg azilsartan medoxomil) and 25 mg chlorthalidone. 30 Tablets Rx Only NDC 6
-
March 15, 2021 · Class II · Terminated · D-0430-2021 · Azilsartan kamedoxomil and chlorthalidone
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/12.5 mg 30 Tablets Rx Only NDC 60631-412-30 Manufactured for: arbor Pharmaceuticals, LLC. Atlanta, GA 30328
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).
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