Quick answers
- What is Duraclon?
- Duraclon is a brand name of Clonidine, a prescription medicine. The FDA NDC Directory lists 1 Duraclon product in 1 strength and form.
- Who makes Duraclon?
- Mylan Institutional holds the FDA application for Duraclon (NDA020615, approved October 2, 1996).
- Is there a generic or store brand of Duraclon?
- Other products of Clonidine are listed with the FDA, but none in exactly the same strength and form as a Duraclon product.
- Has Duraclon been recalled?
- FDA enforcement reports list 1 recall of Duraclon products; the newest started April 13, 2022. A recall usually concerns specific lots, not every product.
What Duraclon is
Each Duraclon product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Clonidine · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| clonidine hydrochloride 0.1 mg/mL injection, solution (epidural) | Duraclon | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Clonidine →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA020615 | Mylan Institutional | October 2, 1996 | 1 |
Companies that list Duraclon
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Duraclon products.
- Mylan Institutional LLC1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 13, 2022 · Class II · Terminated · D-1091-2022
cGMP deviations: Temperature abuse
Duraclon (clonidine HCl injection, USP), 1000 mcg/10 mL (100 mcg/mL), 10 mL single-dose vial, Rx only, MFG: Mylan Pharma, NDC 67457-218-10 — Mckesson Medical-Surgical Inc. Corporate Office
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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.