Active ingredient
Nalmefene
5 finished FDA listings contain Nalmefene as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- NALMEFENE, NALMEFENE HYDROCHLORIDE
- Dosage forms
- Injection, Solution, Solution, Spray
- Routes
- Intramuscular, Intravenous, Nasal, Subcutaneous
- Manufacturers / labelers
- 3
- Strengths listed
- .1 mg/ml · 1 mg/ml · 1.5 mg/.5ml · 2 mg/2ml · 2.7 mg/100ul
- Brand names in FDA listings
- Nalmefene Hydrochloride, Opvee, Zurnai
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 31479
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 212955 | KNOA PHARMA | 2022-02-08 | 1 |
| NDA 217470 | INDIVIOR | 2023-05-22 | 1 |
| ANDA 216007 | CHENGDU SHUODE | 2023-11-15 | 2 |
| NDA 218590 | KNOA PHARMA | 2024-08-07 | 1 |
Official labeling on DailyMed
- ZURNAI (NALMEFENE HYDROCHLORIDE) INJECTION, SOLUTION [KNOA PHARMA LLC ] · version 8 · 2026-08-19
- NALMEFENE HYDROCHLORIDE INJECTION, SOLUTION [KNOA PHARMA LLC] · version 7 · 2026-05-06
- OPVEE (NALMEFENE HYDROCHLORIDE) SPRAY [INDIVIOR INC.] · version 8 · 2026-01-09
- NALMEFENE HYDROCHLORIDE (NALMEFENE HYDROCHLORIDE INJECTION) SOLUTION [CHENGDU SHUODE PHARMACEUTICAL CO., LTD] · version 5 · 2024-01-10
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.