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Butorphanol Tartrate 1 mg/mL Injection, Solution, 1 mL — NDC 00143-9864-10 package photo
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Butorphanol Tartrate 1 mg/mL Injection, Solution, 1 mL — NDC 0143-9864-10 (Billing 00143-9864-10)

by Hikma Pharmaceuticals USA Inc. · 1 mL in 1 VIAL, SINGLE-DOSE

This is a package of 1 mL of Butorphanol Tartrate 1 mg/mL Injection, Solution from Hikma Pharmaceuticals USA Inc., marketed since May 2009 and currently FDA-listed. It is this product's only package size.

NDC 00143-9864-10
🏷️ FDA NDC (as labeled) 0143-9864-10 billing pads the labeler segment with a zero
Rx only Generic On market CIV ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0143-9864-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0143 labeler · 9864 product · 10 package
Package marketed since
May 1, 2009
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
1 mL per package
Barcode (UPC-A, from the NDC)
3 0143986410 3
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0143-9864-10
Product NDC 0143-9864
11-digit billing NDC 00143986410
NCPDP billing unit ML — per mL (volume)
RxCUI 886627, 1728351
UNII 2L7I72RUHN
Application # ANDA078400
SPL Set ID bded5531-8847-4576-9a29-3e44f979d2e0
Established class (EPC) Opioid Agonist/Antagonist
Mechanism of action Competitive Opioid Antagonists; Partial Opioid Agonists
DEA schedule CIV
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-05-01
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance BUTORPHANOL TARTRATE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 004287
GCN 16550
HICL code 001777
Ingredient (HICL) Butorphanol Tartrate
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H3
Therapeutic class — intermediate (HIC2) Analgesics
HIC3 code H3A
Therapeutic class — specific (HIC3) Opioid Analgesics
AHFS code 28:08.12.00
AHFS class Opioid Partial Agonists
FDB label name BUTORPHANOL 1 MG/ML VIAL
FDB brand name Butorphanol Tartrate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 004287
  • GCN: 16550
  • HICL (First Databank): 001777
  • AHFS class code: 28:08.12.00
  • RxCUI (RxNorm): 886627
Why two NDCs? The FDA registers this code as 0143-9864-10 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00143-9864-10. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Opioid Agonist/Antagonist class.

Pharmacologic class Opioid Agonist/Antagonist
Drug family (ATC) Morphinan derivatives
How it works Partial Opioid Agonists, Competitive Opioid Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name BUTORPHANOL 1 MG/ML VIAL Ingredient Butorphanol Tartrate
📖 What it is MedlinePlus · NLM

Butorphanol injection is used to relieve severe pain. Butorphanol injection is also used to relieve pain during labor and to prevent pain and decrease awareness before or during surgery. Butorphanol is in a class of medications called opioid agonist-antagonists. It works by changing the way the body senses pain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats severe pain when other options are not enough. It is also used for pain during labor and before or during surgery. Your care team decides which applies to you.
  • A healthcare professional gives it into a muscle or a vein. For pain, doses are usually spaced a few hours apart and only as needed. Your prescriber sets the plan for you.
  • Sleepiness, dizziness, and nausea or vomiting are the most common. Headache, constipation, and dry mouth can also happen. If you have slow breathing, trouble waking, or an allergic...
  • Avoid alcohol. Mixing it with alcohol, benzodiazepines, sleep aids, or other opioids can slow your breathing dangerously. Tell us about antidepressants, migraine medicines, and any...
📖 Read our full Butorphanol Injection guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00143-9864-10 You're viewing this Main listing 1 mL in 1 VIAL, SINGLE-DOSE 2009-05-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Butorphanol Tartrate 1 mg/mLthis 00143-9864-10 Hikma 1 ml — AP FDA listed —
Butorphanol Tartrate 1 mg/mL 00409-1623-01 Hospira, 10 vials — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2009
On the market since
May 2009
📍
2026
Currently FDA-listed
17 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Butorphanol Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerHikma Pharmaceuticals USA Inc.
Application holderHIKMA FARMACEUTICA (PORTUGAL) SA
FDA applicationANDA078400 (ANDA)
Labeler code00143
First marketedMay 2009
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio726 products on file

More NDCs from Hikma Pharmaceuticals USA Inc. labeler code 00143

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔒 Drug Abuse and Dependence 🔒 Controlled Substance 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Addiction, Abuse, and Misuse Butorphanol Tartrate Injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing Butorphanol Tartrate Injection, and monitor all patients regularly for the development of these behaviors or conditions [see WARNINGS ].

Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Butorphanol Tartrate Injection. Monitor for respiratory depression, especially during initiation of Butorphanol Tartrate Injection or following a dose increase [see WARNINGS ]. Neonatal Opioid Withdrawal Syndrome Prolonged use of butorphanol Tartrate Injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts.

If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS ]. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see WARNINGS , PRECAUTIONS; Drug Interactions ].

Reserve concomitant prescribing of butorphanol and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

🎯 Indications and Usage 108 words ▾

INDICATIONS AND USAGE 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, and misuse, with opioids, even at recommended doses [see WARNINGS ], reserve Butorphanol Tartrate Injection for use in patients for whom alternative treatment options [e.g. non-opioid analgesics] Have not been tolerated, or are not expected to be tolerated Have not provided adequate analgesia, or are not expected to provide adequate analgesia

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Important Dosage and Administration Instructions Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see WARNINGS ]. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with Butorphanol Tartrate Injection and adjust the dosage accordingly [see WARNINGS ].

Initial Dosage Factors to be considered in determining the dose are age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used, and surgical procedure involved. Use in the elderly, patients with hepatic or renal disease, or in labor requires extra caution (see PRECAUTIONS section and CLINICAL PHARMACOLOGY: Individualization of Dosage section ). The following doses are for patients who do not have impaired hepatic or renal function and who are not on CNS active agents.

Use for Pain Intravenous: The usual recommended single dose for IV administration is 1 mg repeated every 3 to 4 hours as necessary. The effective dosage range, depending on the severity of pain, is 0.5 to 2 mg repeated every 3 to 4 hours. Intramuscular: The usual recommended single dose for IM administration is 2 mg in patients who will be able to remain recumbent, in the event drowsiness or dizziness occurs.

This may be repeated every 3 to 4 hours, as necessary. The effective dosage range depending on the severity of pain is 1 to 4 mg repeated every 3 to 4 hours. There are insufficient clinical data to recommend single doses above 4 mg.

Use as Preoperative/Preanesthetic Medication The preoperative medication dosage of Butorphanol Tartrate Injection should be individualized (see CLINICAL PHARMACOLOGY: Individualization of Dosage section). The usual adult dose is 2 mg IM, administered 60 to 90 minutes before surgery. This is approximately equivalent in sedative effect to 10 mg morphine or 80 mg meperidine.

Use in Balanced Anesthesia The usual dose of Butorphanol Tartrate Injection is 2 mg IV shortly before induction and/or 0.5 mg to 1 mg IV in increments during anesthesia. The increment may be higher, up to 0.06 mg/kg (4mg/70kg), depending on previous sedative, analgesic, and hypnotic drugs administered. The total dose of Butorphanol Tartrate Injection will vary; however, patients seldom require less than 4 mg or more than 12.5 mg (approximately 0.06 mg/kg to 0.18 mg/kg).

Labor In patients at full term in early labor a 1 to 2 mg dose of Butorphanol Tartrate Injection IV or IM may be administered and repeated after 4 hours. Alternative analgesia should be used for pain associated with delivery or if delivery is expected to occur within 4 hours. If concomitant use of Butorphanol Tartrate Injection with drugs that may potentiate its effects is deemed necessary (see PRECAUTIONS: Drug Interactions ), the lowest effective dose should be employed.

Dosage Modifications in Elderly Patients and Patients with Renal or Hepatic Impairment The initial dose sequence in elderly patients and patients with hepatic or renal impairment should be limited to 1 mg followed, if needed, by 1 mg in 90 to 120 minutes. The repeat dose sequence should be determined by the patient’s response rather than at fixed times but will generally be no less than at 6 hours intervals (see [see CLINICAL PHARMACOLOGY : Individualization of Dosage and PRECAUTIONS ). Titration and Maintenance of Therapy Individually titrate Butorphanol Tartrate Injection to a dose that provides adequate analgesia and minimizes adverse reactions.

Continually reevaluate patients receiving Butorphanol Tartrate Injection to assess the maintenance of pain control and the relative incidence of adverse reactions,… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 74 words ▾

CONTRAINDICATIONS Butorphanol Tartrate Injection is contraindicated in: Patients with significant respiratory depression [see WARNINGS ] Patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS ] Patients with known or suspected gastrointestinal obstruction, including paralytic ileus (see WARNINGS ) Patients with hypersensitivity to butorphanol tartrate,the preservative benzethonium chloride in the multiple dose vial, or any of the formulation excipients (e.g., anaphylaxis) (see WARNINGS )

⚠️ Warnings ~3 min read ▾

WARNINGS Addiction, Abuse, and Misuse Butorphanol Tartrate Injection contains butorphanol, a Schedule IV controlled substance. As an opioid, Butorphanol Tartrate Injection exposes users to the risks of addiction, abuse, and misuse (see DRUG ABUSE AND DEPENDENCE ). Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Butorphanol Tartrate Injection.

Addiction can occur at recommended dosages and if the drug is misused or abused. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing Butorphanol Tartrate Injection, and monitor all patients receiving Butorphanol Tartrate Injection for the development of these behaviors or conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression).

The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as Butorphanol Tartrate Injection, but use in such patients necessitates intensive counseling about the risks and proper use of Butorphanol Tartrate Injection along with intensive monitoring for signs of addiction, abuse, and misuse. Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.

Consider these risks when prescribing or dispensing Butorphanol Tartrate Injection. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.

Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status [see OVERDOSAGE ].

Carbon dioxide (CO 2 ) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of Butorphanol Tartrate Injection, the risk is greatest during the initiation of therapy or following a dosage increase. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with and following dosage increases of Butorphanol Tartrate Injection.

To reduce the risk of respiratory depression, proper dosing and titration of Butorphanol Tartrate Injection are essential [see DOSAGE AND ADMINISTRATION ]. Overestimating the Butorphanol Tartrate Injection dosage when converting patients from another opioid product can result in a fatal overdose with the first dose. Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia.

Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper [see DOSAGE AND ADMINISTRATION ]. Neonatal Opioid Withdrawal Syndrome Prolonged use of Butorphanol Tartrate Injection during pregnancy can result in withdrawal in the neonate.

Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropr… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS Clinical Trial Experience A total of 1658 patients were studied in premarketing clinical trials of Butorphanol Tartrate Injection.. In nearly all cases the type and incidence of side effects with butorphanol were those commonly observed with opioid analgesics. The adverse experiences described below are based on data from short-term and long-term clinical trials in patients receiving Butorphanol Tartrate Injection.

The most frequently reported adverse experiences across all clinical trials with Butorphanol Tartrate Injection and Nasal Spray were somnolence (43%), dizziness (19%), nausea and/or vomiting (13%). In long-term trials with the nasal spray only, nasal congestion (13%) and insomnia (11%) were frequently reported. The following adverse experiences were reported at a frequency of 1% or greater in clinical trials and were considered to be probably related to the use of butorphanol: Body as a Whole: Asthenia/lethargy, headache, sensation of heat Cardiovascular: Vasodilation, palpitations Digestive: Anorexia, constipation, dry mouth, nausea and/or vomiting, stomach pain Nervous: Anxiety, confusion, dizziness, euphoria, floating feeling, insomnia, nervousness, paresthesia, somnolence, tremor Respiratory: Cough, dyspnea Skin and Appendages: sweating, pruritus Special Senses: blurred vision, ear pain, tinnitus, unpleasant taste The following adverse experiences were reported with a frequency of less than 1% in clinical trials and were considered to be probably related to the use of butorphanol: Cardiovascular: hypotension, syncope Nervous: abnormal dreams, agitation, dysphoria, hallucinations, hostility, withdrawal symptoms Skin and Appendages: rash/hives Urogenital: impaired urination The following infrequent additional adverse experiences were reported in a frequency of less than 1% of the patients studied in short-term Butorphanol Tartrate Nasal Spray trials or trials of Butorphanol Tartrate Injection and under circumstances where the association between these events and butorphanol administration is unknown.

They are being listed as alerting information for the physician physician due to their clinical significance.. Body as a Whole: Edema Cardiovascular: Chest pain, hypertension, tachycardia Nervous: Depression Respiratory: Shallow breathing Postmarketing Experience The following adverse reactions have been identified during post approval use of Butorphanol Tartrate Injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Anaphylaxis: Anaphylaxis has been reported with ingredients contained in Butorphanol Tartrate Injection.

Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids (see CLINICAL PHARMACOLOGY ). To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-233-2001 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🤰 Pregnancy 212 words ▾

Pregnancy Pregnancy Category C: Reproduction studies in mice, rats, and rabbits during organogenesis did not reveal any teratogenic potential to butorphanol. However, pregnant rats treated subcutaneously with butorphanol at 1 mg/kg (5.9 mg/m 2 ) had a higher frequency of stillbirths than controls. Butorphanol at 30 mg/kg/oral (360 mg/m 2 ) and 60 mg/kg/oral (720 mg/m 2 ) also showed higher incidences of post-implantation loss in rabbits.

There are no adequate and well-controlled studies of Butorphanol Tartrate Injection in pregnant women before 37 weeks of gestation. Butorphanol Tartrate Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the infant. Fetal/Neonatal Adverse Reactions Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth.

Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see WARNINGS ].

🧒 Pediatric Use 26 words ▾

Pediatric Use Butorphanol is not recommended for use in patients below 18 years of age because safety and efficacy have not been established in this population.

🧓 Geriatric Use 181 words ▾

Geriatric Use Elderly patients (aged 65 years or older) may have increased sensitivity to Butorphanol Tartrate Injection. In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration.

Titrate the dosage of Butorphanol Tartrate Injection slowly in geriatric patients and monitor closely for signs of central nervous system and respiratory depression [see WARNINGS ]. This drug is known to be known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

🆘 Overdosage ~1 min read ▾

OVERDOSAGE Clinical Presentation Acute overdose with Butorphanol Tartrate Injection can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations. Treatment of Overdose In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed.

Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support techniques. The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose.

For clinically significant respiratory or circulatory depression secondary to butorphanol overdose, administer an opioid antagonist. As butorphanol is a mixed opioid agonist/antagonist, larger doses of naloxone or nalmefene may be needed to reverse the effects of an overdose. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to butorphanol overdose.

Because the duration of opioid reversal is expected to be less than the duration of action of butorphanol in Butorphanol Tartrate Injection, carefully monitor the patient until spontaneous respiration is reliably re-established. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information. In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome.

The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Mechanism of Action: Butorphanol is a partial opioid agonist at the mu opioid receptor and a full agonist at the kappa opioid receptor.The principal therapeutic action of butorphanol is analgesia. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The precise mechanism of the analgesic action is unknown.

However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug. Pharmacodynamics: The analgesic effect of butorphanol is influenced by the route of administration. Onset of analgesia is within a few minutes for intravenous administration and within 15 minutes for intramuscular injection.

Peak analgesic activity occurs within 30 to 60 minutes following intravenous and intramuscular administration. The duration of analgesia varies depending on the pain model as well as the route of administration, but is generally 3 to 4 hours with IM and IV doses as defined by the time 50% of patients required remedication. In postoperative studies, the duration of analgesia with IV or IM butorphanol was similar to morphine, meperidine, and pentazocine when administered in the same fashion at equipotent doses (see CLINICAL PHARMACOLOGY , Clinical Trials ).

Effects on the Central Nervous System Butorphanol produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to both increases in carbon dioxide tension and electrical stimulation. In human studies involving individuals without significant respiratory dysfunction, 2 mg of butorphanol IV and 10 mg of morphine sulfate IV depressed respiration to a comparable degree.

At higher doses, the magnitude of respiratory depression with butorphanol is not appreciably increased; however, the duration of respiratory depression is longer. Respiratory depression noted after administration of butorphanol to humans by any route is reversed by treatment with naloxone, a specific opioid antagonist (see OVERDOSAGE ). Butorphanol, like other mixed agonist-antagonists with a high affinity for the kappa receptor, may produce unpleasant psychotomimetic effects in some individuals.

Nausea and/or vomiting may be produced by doses of 1 mg or more administered by any route. In human studies of butorphanol (see CLINICAL PHARMACOLOGY; Clinical Trials ), sedation is commonly noted at doses of 0.5 mg or more. Narcosis is produced by 10 to 12 mg doses of butorphanol administered over 10 to 15 minutes intravenously.

Butorphanol causes miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origins may produce similar findings). Marked mydriasis rather than miosis may be seen due to hypoxia in overdose situations.

Effects on the Gastrointestinal Tract and Other Smooth Muscle Butorphanol causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum. Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm, resulting in constipation.

Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase. Effects on the Cardiovascular System Hemodynamic changes noted during cardiac catheterization in patients receiving single 0.025 mg/kg intravenous doses of butorphanol have included increases in pulmonary artery pressure, wedge pressure and vascular resistance, increases in left ventricular end diastolic pressure and in systemic arterial pressure. E… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 93 words ▾

Mechanism of Action: Butorphanol is a partial opioid agonist at the mu opioid receptor and a full agonist at the kappa opioid receptor.The principal therapeutic action of butorphanol is analgesia. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The precise mechanism of the analgesic action is unknown.

However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.

📦 How Supplied / Storage and Handling 134 words ▾

HOW SUPPLIED Butorphanol Tartrate Injection is supplied as follows: 1 mg/mL, 1 mL vial, 10 vials per carton (NDC 0143-9864-10) 2 mg/mL, 1 mL vial, 10 vials per carton (NDC 0143-9867-10) 4 mg/2 mL, 2 mL vial, 10 vials per carton (NDC 0143-9863-10) 20 mg/10 mL, 10 mL vial, 10 vials per carton (NDC 0143-9866-10) Storage Conditions: Store at 20º-25°C (68º-77°F) [See USP Controlled Room Temperature]. Protect from light. Discard unused portion.

Retain in carton until time of use. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A.

Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Distributed by: WEST-WARD A HIKMA COMPANY Eatontown, NJ 07724 Revised: July 2020 PIN199-WES/7

📋 Description 149 words ▾

DESCRIPTION Butorphanol tartrate is an opioid agonist-antagonist of the phenanthrene series. The chemical name is (-)-17-(cyclobutylmethyl) morphinan-3,14-diol [S-(R*,R*)]-2,3-dihydroxybutanedioate(1:1)(salt). The molecular formula is C 21 H 29 NO 2 ,C 4 H 6 O 6 , which corresponds to a molecular weight of 477.55 and the following structural formula: Butorphanol tartrate is a white crystalline substance.

The dose is expressed as the tartrate salt. One milligram of the salt is equivalent to 0.68 mg of the free base. The n-octanol/aqueous buffer partition coefficient of butorphanol is 180:1 at pH 7.5.

Butorphanol Tartrate Injection, USP is a sterile, nonpyrogenic, parenteral, aqueous solution of butorphanol tartrate for intravenous or intramuscular administration. Each milliliter (mL) of solution contains, butorphanol tartrate 1 or 2 mg, 3.3 mg of citric acid, 6.4 mg sodium citrate, and 6.4 mg sodium chloride, and 0.1 mg benzethonium chloride (in multiple dose vial only) as a preservative. Structural Formula

💬 Information for Patients ~2 min read ▾

Information for Patients Addiction, Abuse, and Misuse Inform patients that the use of Butorphanol Tartrate Injection, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see WARNINGS ]. Instruct patients not to share Butorphanol Tartrate Injection with others and to take steps to protect Butorphanol Tartrate Injection from theft or misuse. Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting Butorphanol Tartrate Injection or when the dosage is increased, and that it can occur even at recommended dosages [see WARNINGS ].

Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop. Interactions with Benzodiazepines and Other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if Butorphanol Tartrate Injection is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider [see WARNINGS and PRECAUTIONS; Drug Interactions ]. Serotonin Syndrome Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs.

Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare providers if they are taking, or plan to take serotonergic medications. [see PRECAUTIONS; Drug Interactions ] Anaphylaxis Inform patients that anaphylaxis has been reported with ingredients contained in Butorphanol Tartrate Injection. Advise patients how to recognize such a reaction and when to seek medical attention (see CONTRAINDICATIONS , ADVERSE REACTIONS ).

Pregnancy Neonatal Opioid Withdrawal Syndrome: Inform female patients of reproductive potential that prolonged use of Butorphanol Tartrate Injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated [see WARNINGS , PRECAUTIONS; Pregnancy ] Embryo-Fetal Toxicity: Inform female patients of reproductive potential that Butorphanol Tartrate Injection can cause fetal harm and to inform the healthcare provider of a known or suspected pregnancy [see PRECAUTIONS; Pregnancy ].

Lactation Advise nursing mothers to monitor infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Instruct nursing mothers to seek immediate medical care if they notice these signs [see PRECAUTIONS; Nursing Mothers ]. Infertility Inform patients that chronic use of opioids may cause reduced fertility.

It is not known whether these effects on fertility are reversible (see ADVERSE REACTIONS ). Driving or Operating Heavy Machinery Inform patients that Butorphanol Tartrate Injection may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery and to avoid such tasks while taking this product, until they know how they will react to the medication.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Hypotension associated with syncope during the first hour of dosing with Butorphanol Tartrate Injection has been reported rarely, particularly in patients with past history of similar reactions to opioid analgesics. Therefore, patients should be advised to avoid activities with potential risks. Risks of Driving and Operating Machinery Butorphanol Tartrate Injection may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.

Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of Butorphanol Tartrate Injection and know how they will react to the medication (see PRECAUTIONS ; Information for Patients/Caregivers ). Disorders of Respiratory Function or Control Butorphanol may produce respiratory depression, especially in patients receiving other CNS active agents, or patients suffering from CNS diseases or respiratory impairment. Hepatic and Renal Disease In patients with hepatic or renal impairment, the initial dose of Butorphanol Tartrate Injection should generally be half the recommended adult dose (0.5 mg IV and 1.0 mg IM).

Repeat doses in these patients should be determined by the patient’s response rather than at fixed intervals but will generally be no less than 6 hours apart (see CLINICAL PHARMACOLOGY: Pharmacokinetics and Individualization of Dosage sections). Information for Patients Addiction, Abuse, and Misuse Inform patients that the use of Butorphanol Tartrate Injection, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see WARNINGS ]. Instruct patients not to share Butorphanol Tartrate Injection with others and to take steps to protect Butorphanol Tartrate Injection from theft or misuse.

Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting Butorphanol Tartrate Injection or when the dosage is increased, and that it can occur even at recommended dosages [see WARNINGS ]. Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop. Interactions with Benzodiazepines and Other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if Butorphanol Tartrate Injection is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider [see WARNINGS and PRECAUTIONS; Drug Interactions ].

Serotonin Syndrome Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare providers if they are taking, or plan to take serotonergic medications. [see PRECAUTIONS; Drug Interactions ] Anaphylaxis Inform patients that anaphylaxis has been reported with ingredients contained in Butorphanol Tartrate Injection.

Advise patients how to recognize such a reaction and when to seek medical attention (see CONTRAINDICATIONS , ADVERSE REACTIONS ). Pregnancy Neonatal Opioid Withdrawal Syndrome: Inform female patients of reproductive potential that prolonged use of Butorphanol Tartrate Injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated [see WARNINGS , PRECAUTIONS; Pregnancy ] Embryo-Fetal Toxicity: Inform female patients of reproductive potential that Butorphanol Tartrate Injection can cause fetal harm and to inform the healthcare provider of a known or suspected pregnancy [see PRECAUTIONS; Pregnancy ].

Lactation Advise nursing mothers to monitor infants for increased sleepiness (more than usual), breathing diff… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 121 words ▾

Nursing Mothers Butorphanol has been detected in milk following administration of Butorphanol Tartrate Injection to nursing mothers. The amount an infant would receive is probably clinically insignificant (estimated 4 mcg/L of milk in a mother receiving 2 mg IM four times a day). The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Butorphanol Tartare Injection and any potential adverse effects on the breastfed infant from Butorphanol Tartare Injection or from the underlying maternal condition.

Infants exposed to Butorphanol Tartare Injection through breast milk should be monitored for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped.

🧬 Pharmacokinetics ~2 min read ▾

Pharmacokinetics: Butorphanol Tartrate Injection is rapidly absorbed after IM injection and peak plasma levels are reached in 20 to 40 minutes. Following its initial absorption/distribution phase, the single dose pharmacokinetics of butorphanol by the intravenous and intramuscular routes of administration are similar (see Figure 1). Figure 1—Butorphanol Plasma Levels After IV and IM Administration of 2-mg Dose Serum protein binding is independent of concentration over the range achieved in clinical practice (up to 7 ng/mL) with a bound fraction of approximately 80%.

The volume of distribution of butorphanol varies from 305 to 901 liters and total body clearance from 52 to 154 liters/hr (see Table 1). Table 1 - Mean Pharmacokinetic Parameters of Butorphanol in Young and Elderly Subjects Young subjects (n=24) are from 20 to 40 years old and elderly (n=24) are greater than 65 years of age. Parameters Young Elderly AUC (inf) Area under plasma concentration-time curve after a 1 mg dose.

7.24(1.57) Mean (1 S.D.). 8.71 (2.02) (hr•ng/mL) (4.40 - 9.77) (range of observed values). (4.76 - 13.03) Half-life (h) 4.56 (1.67) 5.61 (1.36) (2.06 - 8.70) (3.25 - 8.79) Volume of Distribution Derived from IV data.

(L) 487 (155) 552 (124) (305 - 901) (305 - 737) Total Body Clearance (L/h) 99 (23) 82 (21) (70 - 154) (52 - 143) The drug is transported across the blood brain and placental barriers and into human milk (see PRECAUTIONS: Labor or Delivery , Nursing Mothers ). Butorphanol is extensively metabolized in the liver. Metabolism is qualitatively and quantitatively similar following intravenous or intramuscular administration.

Oral bioavailability is only 5 to 17% because of extensive first pass metabolism of butorphanol. The major metabolite of butorphanol is hydroxybutorphanol, while norbutorphanol is produced in small amounts. Both have been detected in plasma following administration of butorphanol, with norbutorphanol present at trace levels at most time points.

The elimination half-life of hydroxybutorphanol is about 18 hours and, as a consequence, considerable accumulation (<5-fold) occurs when butorphanol is dosed to steady state. Elimination occurs by urine and fecal excretion. When 3 H labeled butorphanol is administered to normal subjects, most (70 to 80%) of the dose is recovered in the urine, while approximately 15% is recovered in the feces.

About 5% of the dose is recovered in the urine as butorphanol. Forty-nine percent is eliminated in the urine as hydroxybutorphanol. Less than 5% is excreted in the urine as norbutorphanol.

Butorphanol pharmacokinetics in the elderly differ from younger patients (see Table 1). In renally impaired patients with creatinine clearances <30 mL/min, the elimination half-life was approximately doubled and the total body clearance was approximately one half (10.5 hours [clearance 150 L/h] compared to 5.8 hours [clearance 260 L/h] in healthy subjects). No effect on C max or T max was observed after a single dose.

After intravenous administration to patients with hepatic impairment, the elimination half-life of butorphanol was approximately tripled and total body clearance was approximately one half (half-life 16.8 hours, clearance 92 L/h) compared to healthy subjects (half-life 4.8 hours, clearance 175 L/h). The exposure of hepatically impaired patients to butorphanol was significantly greater (about 2-fold) than that in healthy subjects. (see PRECAUTIONS: Hepatic and Renal Disease , Drug Interactions and Geriatric Use and CLINICAL PHARMACOLOGY: Individualization of Dosage ).

Plasma Levels

🧬 Pharmacodynamics 119 words ▾

Pharmacodynamics: The analgesic effect of butorphanol is influenced by the route of administration. Onset of analgesia is within a few minutes for intravenous administration and within 15 minutes for intramuscular injection. Peak analgesic activity occurs within 30 to 60 minutes following intravenous and intramuscular administration.

The duration of analgesia varies depending on the pain model as well as the route of administration, but is generally 3 to 4 hours with IM and IV doses as defined by the time 50% of patients required remedication. In postoperative studies, the duration of analgesia with IV or IM butorphanol was similar to morphine, meperidine, and pentazocine when administered in the same fashion at equipotent doses (see CLINICAL PHARMACOLOGY , Clinical Trials ).

🔒 Drug Abuse and Dependence ~3 min read ▾

DRUG ABUSE AND DEPENDENCE Controlled Substance Butorphanol Tartrate Injection contains butorphanol, a Schedule IV controlled substance. Abuse Butorphanol Tartrate Injection contains butorphanol, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. Butorphanol Tartrate Injection can be abused and is subject to misuse, addiction, and criminal diversion (see WARNINGS ).All patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use.

Prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. “Drug-seeking” behavior is very common in persons with substance use disorders.

Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating health care provider(s). “Doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among drug abusers and people suffering from untreated addiction. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Health care providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction.

Butorphanol Tartrate Injection, like other opioids, can be diverted for non-medical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Risks Specific to Abuse of Butorphanol Tartrate Injection Abuse of Butorphanol Tartrate Injection poses a risk of overdose and death. The risk is increased with concurrent abuse of Butorphanol Tartrate Injection with alcohol and other central nervous system depressants. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.

Dependence Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects.

Physical dependence results in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of… [Excerpted — this section continues on DailyMed.]

🔒 Controlled Substance 12 words ▾

Controlled Substance Butorphanol Tartrate Injection contains butorphanol, a Schedule IV controlled substance.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 215 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Two-year carcinogenicity studies were conducted in mice and rats given butorphanol tartrate in the diet up to 60 mg/kg/day (12 and 24 times the human daily dose of 24 mg/day based on a body surface area comparison, respectively). There was no evidence of carcinogenicity in either species in these studies. Mutagenesis Butorphanol was not genotoxic in the in vitro bacterial reverse mutation assay (Ames) or in an in vitro unscheduled DNA synthesis and repair assay conducted in cultured human fibroblast cells.

Impairment of Infertility In a study where male rats were treated subcutaneously with 0.5 or 2.5 mg/kg butorphanol for 75 days prior to mating to female rats treated subcutaneously with 0.5 or 2.5 mg/kg butorphanol for 14-days prior to mating and throughout gestation and lactation, no adverse effects on fertility were noted (0.2- and 1-times the human daily dose of 24 mg based on body surface area). In a study where male rats were treated orally with 10, 40, or 160 mg/kg for 63 days prior to mating to female rats treated orally with the same doses of butorphanol for 14 days prior to mating, reduced pregnancy rates were reported in the high dose group (65-times the human daily dose of 24 mg based on body surface area).

📄 Package Label / Principal Display Panel 110 words ▾

PRINCIPAL DISPLAY PANEL NDC 0143-9864-10 CIV BUTORPHANOL TARTRATE INJECTION, USP 1 mg/mL FOR IV OR IM USE Rx ONLY 1 mL Single Dose Vial USUAL DOSAGE: See Pacakge Insert. NDC 0143-9864-10 CIV BUTORPHANOL TARTRATE INJECTION, USP 1 mg/mL FOR IV OR IM USE Rx ONLY 1 mL Single Dose Vial USUAL DOSAGE: See Pacakge Insert.

PRINCIPAL DISPLAY PANEL NDC 0143-9867-10 CIV BUTORPHANOL TARTRATE INJECTION, USP 2 mg/mL FOR IV OR IM USE Rx ONLY 1 mL Single Dose Vial USUAL DOSAGE: See Pacakge Insert. NDC 0143-9867-10 CIV BUTORPHANOL TARTRATE INJECTION, USP 2 mg/mL FOR IV OR IM USE Rx ONLY 1 mL Single Dose Vial USUAL DOSAGE: See Pacakge Insert.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Butorphanol Tartrate — the program that covers self-administered drugs. 3 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Butorphanol Tartrate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$463.9K
Claims incl. refills
5.2K
Beneficiaries
1.8K
Spend / beneficiary
$264.47
Spend / claim
$89.90
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
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NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Hikma Pharmaceuticals USA Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Hikma Pharmaceuticals USA Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00143-9859-25 · Hikma 00143-9867-10 · Hikma →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.