Quick answers
- What is Cardene IV?
- Cardene IV is a brand name of Nicardipine, a prescription medicine. The FDA NDC Directory lists 7 Cardene IV products in 3 strengths and forms.
- Who makes Cardene IV?
- Chiesi holds the FDA application for Cardene IV (NDA019734, approved January 30, 1992).
- Is there a generic or store brand of Cardene IV?
- Yes. The FDA NDC Directory lists 2 other products with the same active ingredients, strength and form as a Cardene IV product, 2 of them generic. Ask your pharmacist whether one is right for you.
- Has Cardene IV been recalled?
- FDA enforcement reports list 1 recall of Cardene IV products; the newest started August 6, 2026. A recall usually concerns specific lots, not every product.
What Cardene IV is
Each Cardene IV 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.
Nicardipine · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| nicardipine hydrochloride 0.1 mg/mL injection, solution (intravenous) | Cardene IV | 1 product, 1 company | DailyMed |
| nicardipine hydrochloride 0.2 mg/mL injection, solution (intravenous) | Cardene IV | 1 product, 1 company | DailyMed |
| nicardipine hydrochloride 2.5 mg/10 mL injection, solution (intravenous) | Cardene IV | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Nicardipine →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA019734 | Chiesi | January 30, 1992 | 7 |
Companies that list Cardene IV
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Cardene IV products.
- Baxter Healthcare Corporation7 products
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.
-
August 6, 2026 · Class II · Ongoing · D-0813-2026
CGMP Deviations
CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA — Baxter Healthcare Corporation
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.