Active ingredient
Butorphanol
7 finished FDA listings contain Butorphanol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- BUTORPHANOL TARTRATE
- Dosage forms
- Injection, Solution, Spray, Spray, Metered
- Routes
- Intramuscular, Intravenous, Nasal
- Manufacturers / labelers
- 4
- Strengths listed
- 1 mg/ml · 10 mg/ml · 2 mg/ml
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1841
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 074626 | HOSPIRA | 1997-01-23 | 2 |
| ANDA 075824 | HIKMA | 2002-03-12 | 1 |
| ANDA 075499 | APOTEX | 2002-12-04 | 2 |
| ANDA 078400 | HIKMA FARMACEUTICA | 2009-05-01 | 2 |
Official labeling on DailyMed
- BUTORPHANOL TARTRATE (BUTORPHANOL TARTRATE ) SPRAY [APOTEX CORP.] · version 24 · 2026-09-10
- BUTORPHANOL TARTRATE (BUTORPHANOL TARTRATE ) SPRAY [BRYANT RANCH PREPACK] · version 102 · 2026-03-23
- BUTORPHANOL TARTRATE SPRAY, METERED [HIKMA PHARMACEUTICALS USA INC.] · version 20 · 2026-01-05
- BUTORPHANOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.] · version 28 · 2026-01-05
- BUTORPHANOL TARTRATE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 11 · 2024-04-15
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.