Quick answers
- What is Infumorph 500?
- Infumorph 500 is a brand name of Morphine sulfate, a prescription medicine. The FDA NDC Directory lists 1 Infumorph 500 product in 1 strength and form.
- Who makes Infumorph 500?
- Hikma holds the FDA application for Infumorph 500 (NDA018565, approved September 18, 1984).
- Is there a generic or store brand of Infumorph 500?
- Other products of Morphine sulfate are listed with the FDA, but none in exactly the same strength and form as a Infumorph 500 product.
- Has Infumorph 500 been recalled?
- FDA enforcement reports list 1 recall of Infumorph 500 products; the newest started March 12, 2024. A recall usually concerns specific lots, not every product.
What Infumorph 500 is
Each Infumorph 500 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.
Morphine sulfate · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| morphine sulfate 25 mg/mL injection, solution (epidural, intrathecal) | Infumorph 500 | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Morphine sulfate →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA018565 | Hikma | September 18, 1984 | 1 |
Companies that list Infumorph 500
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Infumorph 500 products.
- Hikma Pharmaceuticals USA Inc.1 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.
-
March 12, 2024 · Class II · Ongoing · D-0392-2024
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01 — Hikma Pharmaceuticals USA Inc.
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.