Duramorph is a brand name of Morphine sulfate, a prescription medicine. The FDA NDC Directory lists 2 Duramorph products in 2 strengths and forms.

Hikma holds the FDA application for Duramorph (NDA018565, approved September 18, 1984).

Is there a generic or store brand of Duramorph?

Other products of Morphine sulfate are listed with the FDA, but none in exactly the same strength and form as a Duramorph product.

Duramorph (Morphine sulfate): maker, FDA approval and generic versions

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Duramorph?: Duramorph is a brand name of Morphine sulfate, a prescription medicine. The FDA NDC Directory lists 2 Duramorph products in 2 strengths and forms.
Who makes Duramorph?: Hikma holds the FDA application for Duramorph (NDA018565, approved September 18, 1984).
Is there a generic or store brand of Duramorph?: Other products of Morphine sulfate are listed with the FDA, but none in exactly the same strength and form as a Duramorph product.
Has Duramorph been recalled?: No recall linked to Duramorph products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Duramorph is

Each Duramorph 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 0.5 mg/mL injection (epidural, intrathecal, intravenous)	Duramorph	None listed	DailyMed
morphine sulfate 1 mg/mL injection (epidural, intrathecal, intravenous)	Duramorph	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.

FDA applications of Duramorph products (Drugs@FDA)
Application	Holder	First approved	Products
NDA018565	Hikma	September 18, 1984	2

Companies that list Duramorph

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Duramorph products.

Hikma Pharmaceuticals USA Inc.2 products

Recalls

No recall linked to Duramorph products (by their NDC code or label) appears in the FDA enforcement reports.

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.

Report an error → · Information for medicine makers

Duramorph