Quick answers
- What is Narcan?
- Narcan is a brand name of Naloxone hydrochloride, a prescription medicine. The FDA NDC Directory lists 3 Narcan products in 1 strength and form.
- Who makes Narcan?
- Emergent holds the FDA application for Narcan (NDA208411, approved November 18, 2015). 2 other companies (repackagers or distributors) also list Narcan products.
- Is there a generic or store brand of Narcan?
- Yes. The FDA NDC Directory lists 4 other products with the same active ingredients, strength and form as a Narcan product, 3 of them generic. Ask your pharmacist whether one is right for you.
- Has Narcan been recalled?
- FDA enforcement reports list 1 recall of Narcan products; the newest started March 15, 2021. A recall usually concerns specific lots, not every product.
What Narcan is
Each Narcan 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.
Naloxone hydrochloride · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| naloxone hydrochloride 4 mg/0.1 mL spray (nasal) | Narcan | 4 products, 3 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Naloxone hydrochloride →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA208411 | Emergent | November 18, 2015 | 3 |
Companies that list Narcan
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Narcan products.
- A-S Medication Solutions1 product
- Proficient Rx LP1 product
- Emergent Devices 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 15, 2021 · Class II · Terminated · D-0473-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Narcan (naloxone HCl) Nasal Spray 4 mg Two Pack This box contains two (2) 4-mg doses of naloxone HCl in 0.1 mL of nasal spray. 0.1 mL intranasal spray per unit For use in the nose only Rx only NDC 69547-353-02 Distribute — Cardinal Health 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.