FDA label
What is butorphanol used for?
The FDA-approved uses of butorphanol, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Butorphanol Tartrate Injection is indicated”
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Butorphanol Tartrate, injection, solution
Indications and Usage, quoted from the label by Hospira, Inc. (ANDA074626). Cross-references to other label sections are left out.
Butorphanol Tartrate Injection is indicated
- as a preoperative or pre-anesthetic medication
- as a supplement to balanced anesthesia
- for the relief of pain during labor, and
- for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use:
Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including butorphanol tartrate, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Source: DailyMed label, set id 9822ca3f-aee2-46e5-8a96-495400e65d10, version 29, effective October 6, 2026. NDC 0409-1623, one of 4 listings for this product.
Butorphanol Tartrate, spray
Indications and Usage, quoted from the label by Apotex Corp. (ANDA075499). Cross-references to other label sections are left out.
Butorphanol tartrate nasal spray is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use:
- Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy, reserve opioid analgesics, including butorphanol tartrate, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Source: DailyMed label, set id b8e48063-0b40-ee43-85c1-4ef2de80c404, version 24, effective September 9, 2026. NDC 60505-0813, one of 2 listings for this product.
Butorphanol Tartrate, spray, metered
Indications and Usage, quoted from the label by Hikma Pharmaceuticals USA Inc. (ANDA075824). Cross-references to other label sections are left out.
Butorphanol Tartrate Nasal Spray is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including Butorphanol Tartrate Nasal Spray, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Source: DailyMed label, set id 5a50d22e-acbe-4b15-9ed6-70713378408a, version 20, effective November 20, 2025. NDC 0054-3090, one of 1 listing for this product.
Questions
What is butorphanol used for?
The FDA label says: “Butorphanol Tartrate Injection is indicated”
What drug class is butorphanol?
FDA lists butorphanol in the Opioid Agonist/Antagonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Butorphanol
- Is Butorphanol a controlled substance?Schedule IV
- Generic for StadolFDA Orange Book
- Generic for Stadol Preservative FreeFDA Orange Book
- Opioid Agonist/Antagonists listFDA drug class
- NDC 0054-3090Butorphanol NDC record
- NDC 0143-9864Butorphanol NDC record
- NDC 0143-9867Butorphanol NDC record
- Schedule IV drugs listDEA schedule