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Rocuronium 10 mg/mL Injection, Solution — NDC 65219-0697-10 package photo
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Rocuronium 10 mg/mL Injection, Solution — NDC 65219-697-10 (Billing 65219-0697-10)

by Fresenius Kabi USA, LLC · 10 VIAL in 1 TRAY / 10 mL in 1 VIAL

This is a package of Rocuronium 10 mg/mL Injection, Solution from Fresenius Kabi USA, LLC, marketed since Oct 2023 and currently FDA-listed. It is this product's only package size.

NDC 65219-0697-10
🏷️ FDA NDC (as labeled) 65219-697-10 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65219-697-10
Product NDC 65219-697
11-digit billing NDC 65219069710
RxCUI 2720024, 2720026
UNII I65MW4OFHZ
UPC 0365219444046, 0365219697015, 0365219442028, 0365219695011
Application # NDA217472
SPL Set ID 9a622308-7bda-4ca0-9de5-d6b3b4be3384
Established class (EPC) Nondepolarizing Neuromuscular Blocker
Physiologic effect Neuromuscular Nondepolarizing Blockade
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-10-11
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance ROCURONIUM BROMIDE
Quick answers
  • RxCUI (RxNorm): 2720024
Why two NDCs? The FDA registers this code as 65219-697-10 — a 5-3-2 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 product segment → 65219-0697-10. 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 Nondepolarizing Neuromuscular Blocker class.

Pharmacologic class Nondepolarizing Neuromuscular Blocker
Drug family (ATC) Other quaternary ammonium compounds
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

📗 Our plain-language guide HelloPharmacist
  • It relaxes your muscles during general anesthesia. That helps the team place a breathing tube and keeps you still during surgery or while you are on a ventilator. You will also be...
  • Only through an IV by trained anesthesia staff in a hospital or surgical setting. You won't take it yourself. They adjust the dose for you and use a nerve stimulator to track how i...
  • Most people notice little. Temporary changes in blood pressure are the most common effect. Less often, people have a fast heartbeat, nausea, vomiting, rash, itching or hiccups. You...
  • Tell them about any past allergic reaction to a muscle relaxant. Also mention myasthenia gravis, liver disease, heart or lung blood vessel problems, and any medicines you take, suc...
📖 Read our full Rocuronium 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
65219-0697-10 You're viewing this Main listing 10 VIAL in 1 TRAY / 10 mL in 1 VIAL 2023-10-11 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rocuronium 10 mg/mL 65219-0065-05 Fresenius 10 vials $0.394 AP Availability likely —
rocuronium bromide 10 mg/mL 00409-1403-10 Hospira, 10 vials $0.394 AP Availability likely —
rocuronium bromide 10 mg/mL 00409-3189-10 Hospira, 10 vials $0.394 AP Availability likely —
Rocuronium Bromide 10 mg/mL 25021-0687-05 Sagent 10 vials $0.394 AP Availability likely —
rocuronium bromide 10 mg/mL 39822-4200-02 XGen 10 vials $0.394 AP Availability likely —
Rocuronium 10 mg/mL 63323-0426-05 Fresenius 10 vials $0.394 AP Availability likely —
Rocuronium Bromide 10 mg/mL 71288-0700-06 Meitheal 10 vials $0.394 AP Availability likely —
Rocuronium Bromide 10 mg/mL 71839-0141-10 BE 10 vials $0.394 AP Availability likely —
Rocuronium Bromide 10 mg/mL 72572-0650-10 Civica, 10 vials $0.394 AP Availability likely —
Rocuronium Bromide 10 mg/mL 67457-0228-05 Mylan 10 vials $0.394 AP Availability likely —
Rocuronium 10 mg/mL 65219-0442-05 Fresenius 10 vials $0.394 — Availability likely —
Rocuronium 10 mg/mL 81565-0204-02 Phlow 10 vials $0.394 AP Availability likely —
Rocuronium Bromide 10 mg/mL 00409-9558-49 Hospira, 10 vials $0.394 AP Availability likely —
Rocuronium Bromide 10 mg/mL 00143-9250-10 Hikma 10 vials $0.394 AP Availability likely —
Rocuronium Bromide 10 mg/mL 65145-0130-10 Caplin 10 vials $0.394 AP Availability likely —
Rocuronium 10 mg/mL 65219-0695-05 Fresenius 10 vials $0.394 — Availability likely —
Rocuronium 10 mg/mL 65219-0444-10 Fresenius 10 vials — — FDA listed —
Rocuronium 10 mg/mLthis 65219-0697-10 Fresenius 10 vials — — FDA listed —
Rocuronium Bromide 10 mg/mL 00781-3220-92 Sandoz 10 vials — AP FDA listed —
Rocuronium Bromide 10 mg/mL 51662-1355-01 HF 10 ml — AP FDA listed —
rocuronium bromide 10 mg/mL 00409-5160-10 Hospira, 10 vials — AP FDA listed —
rocuronium bromide 10 mg/mL 00409-7037-10 Hospira, 10 vials — AP FDA listed —
Rocuronium Bromide 10 mg/mL 71288-0718-11 Meitheal 10 vials — AP FDA listed —
Rocuronium Bromide 10 mg/mL 71839-0142-10 BE 10 vials — AP FDA listed —
rocuronium bromide 10 mg/mL 71872-7036-01 Medical 1 vial — AP FDA listed —
Rocuronium Bromide 10 mg/mL 71872-7207-01 Medical 1 vial — AP FDA listed —
Rocuronium Bromide 10 mg/mL 51662-1640-01 HF 5 ml — AP FDA listed —
Rocuronium Bromide 10 mg/mL 71872-7317-01 Medical 1 vial — AP FDA listed —
Rocuronium Bromide 10 mg/mL 72572-0651-10 Civica, 10 vials — AP FDA listed —
Rocuronium Bromide 10 mg/mL 68083-0365-10 Gland 10 vials — AP FDA listed —
rocuronium bromide 10 mg/mL 71872-7309-01 Medical 1 vial — AP FDA listed —
Rocuronium Bromide 10 mg/mL 51662-1354-01 HF 5 ml — AP FDA listed —
Rocuronium Bromide 10 mg/mL 71872-7344-01 Medical 1 vial — AP FDA listed —
Rocuronium Bromide 10 mg/mL 84549-0131-10 ProPharma 10 ml — AP FDA listed —
Rocuronium Bromide 10 mg/mL 84549-0141-10 ProPharma 5 ml — AP FDA listed —
Rocuronium Bromide 10 mg/mL 71872-7372-01 Medical 1 vial — AP FDA listed —
Rocuronium Bromide 10 mg/mL 65145-0131-10 Caplin 10 vials — AP FDA listed —
Rocuronium Bromide 10 mg/mL 51662-1641-01 HF 10 ml — AP FDA listed —
Rocuronium Bromide 10 mg/mL 00143-9251-10 Hikma 10 vials — AP FDA listed —
Rocuronium Bromide 10 mg/mL 68083-0364-10 Gland 10 vials — AP FDA listed —
Rocuronium Bromide 10 mg/mL 84549-0687-05 ProPharma 5 ml — AP FDA listed —
Rocuronium 10 mg/mL 76045-0221-50 Fresenius 10 syringes — — FDA listed —
Rocuronium Bromide 10 mg/mL 51662-1710-01 HF 10 ml — AP FDA listed —
Rocuronium Bromide 10 mg/mL 51662-1711-01 HF 5 ml — AP FDA listed —
Rocuronium 10 mg/mL 76045-0220-50 Fresenius 10 syringes — — FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2023
On the market since
Oct 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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

LabelerFresenius Kabi USA, LLC
Application holderFRESENIUS KABI USA LLC
FDA applicationNDA217472 (NDA)
Labeler code65219
First marketedOct 2023
Product typeHuman Prescription Drug
Portfolio554 products on file
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.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 74 words ▾

1 INDICATIONS AND USAGE Rocuronium Bromide Injection is indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Rocuronium Bromide Injection is a nondepolarizing neuromuscular blocking agent indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Rocuronium Bromide Injection should only be administered by experienced clinicians or trained individuals supervised by an experienced clinician familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents. ( 2.1 ) Individualize the dose for each patient. ( 2.1 ) Peripheral nerve stimulator recommended for determination of drug response and need for additional doses, and to evaluate recovery.

( 2.1 ) Store Rocuronium Bromide Injection with cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product. ( 2.1 ) Tracheal intubation : Recommended initial dose is 0.6 mg/kg. ( 2.2 ) Rapid sequence intubation : 0.6 to 1.2 mg/kg.

( 2.3 ) Maintenance doses : Guided by response to prior dose, not administered until recovery is evident. ( 2.4 ) Continuous infusion : Initial rate of 10 to 12 mcg/kg/min. Start only after early evidence of spontaneous recovery from an intubating dose.

( 2.5 )

2.1Important Dosing and Administration Information Rocuronium Bromide Injection is for intravenous use only. Rocuronium Bromide Injection should only be administered by experienced clinicians or trained individuals supervised by an experienced clinician familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents. Doses of Rocuronium Bromide Injection should be individualized and a peripheral nerve stimulator should be used to monitor drug effect, need for additional doses, adequacy of spontaneous recovery or antagonism, and to decrease the complications of overdosage if additional doses are administered.

The dosage information which follows is derived from studies based upon units of drug per unit of body weight. It is intended to serve as an initial guide to clinicians familiar with other neuromuscular blocking agents to acquire experience with Rocuronium Bromide Injection. In patients in whom potentiation of, or resistance to, neuromuscular block is anticipated, a dose adjustment should be considered [see Dosage and Administration ( 2.6 ), Warnings and Precautions ( 5.10 , 5.13 ), Drug Interactions ( 7.2 , 7.3 , 7.4 , 7.5 , 7.6 , 7.8 , 7.10 ), Use in Specific Populations ( 8.6 )] .

Risk of Medication Errors Accidental administration of neuromuscular blocking agents may be fatal. Store Rocuronium Bromide Injection with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product [see Warnings and Precautions ( 5.3 )] .

2.2Dose for Tracheal Intubation The recommended initial dose of Rocuronium Bromide Injection, regardless of anesthetic technique, is 0.6 mg/kg. Neuromuscular block sufficient for intubation (80% block or greater) is attained in a median (range) time of 1 (0.4-6) minute(s) and most patients have intubation completed within 2 minutes. Maximum blockade is achieved in most patients in less than 3 minutes.

This dose may be expected to provide 31 (15-85) minutes of clinical relaxation under opioid/nitrous oxide/oxygen anesthesia. Under halothane, isoflurane, and enflurane anesthesia, some extension of the period of clinical relaxation should be expected [see Drug Interactions ( 7.3 )] . A lower dose of Rocuronium Bromide Injection (0.45 mg/kg) may be used.

Neuromuscular block sufficient for intubation (80% block or greater) is attained in a median (range) time of 1.3 (0.8-6.2) minute(s), and most patients have intubation completed within 2 minutes. Maximum blockade is achieved in most patients in less than 4 minutes. This dose may be expected to provide 22 (12-31) minutes of clinical relaxation under opioid/nitrous oxide/oxygen anesthesia.

Patients receiving this low dose of 0.45 mg/kg who achieve less than 90% block (about 16% of these patients) may have a more rapid time to 25% recovery, 12 to 15 minutes. A large bolus dose of 0.9 or 1.2 mg/kg can be administered under opioid/nitrous oxide/oxygen anesthesia without adverse effects to the cardiovascular… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 54 words ▾

3 DOSAGE FORMS AND STRENGTHS Rocuronium Bromide Injection is a clear, colorless to yellow/orange solution, free from visible particulate matter available as: 50 mg/5 mL (10 mg/mL), single-dose vials 100 mg/10 mL (10 mg per mL), single-dose vials 50 mg/5 mL (10 mg/mL). ( 3 ) 100 mg/10 mL (10 mg/mL). ( 3 )

⛔ Contraindications 45 words ▾

4 CONTRAINDICATIONS Rocuronium Bromide Injection is contraindicated in patients known to have hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents [see Warnings and Precautions ( 5.2 )] . Hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Appropriate Administration and Monitorin g: Use only if facilities for intubation, mechanical ventilation, oxygen therapy, and an antagonist are immediately available. ( 5.1 ) Anaphylaxis : Severe anaphylaxis has been reported. Consider cross-reactivity among neuromuscular blocking agents.

( 5.2 ) Risk of Death due to Medication Errors : Accidental administration can cause death. ( 5.3 ) Need for Adequate Anesthesia : Must be accompanied by adequate anesthesia or sedation. ( 5.4 ) Residual Paralysis : Consider using a reversal agent in cases where residual paralysis is more likely to occur.

( 5.5 )

5.1Appropriate Administration and Monitoring Rocuronium Bromide Injection should be administered in carefully adjusted dosages by or under the supervision of experienced clinicians who are familiar with the drug's actions and the possible complications of its use. Rocuronium Bromide Injection should not be administered unless facilities for intubation, mechanical ventilation, oxygen therapy, and an antagonist are immediately available. It is recommended that clinicians administering neuromuscular blocking agents such as Rocuronium Bromide Injection employ a peripheral nerve stimulator to monitor drug effect, need for additional doses, adequacy of spontaneous recovery or antagonism, and to decrease the complications of overdosage if additional doses are administered.

5.2Anaphylaxis Severe anaphylactic reactions to neuromuscular blocking agents, including Rocuronium Bromide Injection, have been reported. These reactions have, in some cases (including cases with Rocuronium Bromide Injection), been life threatening and fatal. Due to the potential severity of these reactions, the necessary precautions, such as the immediate availability of appropriate emergency treatment, should be taken.

Precautions should also be taken in those patients who have had previous anaphylactic reactions to other neuromuscular blocking agents, since cross-reactivity between neuromuscular blocking agents, both depolarizing and nondepolarizing, has been reported.

5.3Risk of Death due to Medication Errors Administration of Rocuronium Bromide Injection results in paralysis, which may lead to respiratory arrest and death, a progression that may be more likely to occur in a patient for whom it is not intended. Confirm proper selection of intended product and avoid confusion with other injectable solutions that are present in critical care and other clinical settings. If another healthcare provider is administering Rocuronium Bromide Injection, ensure that the intended dose is clearly labeled and communicated.

5.4Need for Adequate Anesthesia Rocuronium Bromide Injection has no known effect on consciousness, pain threshold, or cerebration. Therefore, its administration must be accompanied by adequate anesthesia or sedation.

5.5Residual Paralysis To prevent complications resulting from residual paralysis from Rocuronium Bromide Injection, it is recommended to extubate only after the patient has recovered sufficiently from neuromuscular block. Geriatric patients (65 years or older) may be at increased risk for residual neuromuscular block. Other factors which could cause residual paralysis after extubation in the post- operative phase (such as drug interactions or patient condition) should also be considered.

If not used as part of standard clinical practice the use of a reversal agent should be considered, especially in those cases where residual paralysis is more likely to occur.

5.6Long-Term Use in an Intensive Care Unit Rocuronium Bromide Injection has not been studied for long-term use in the intensive care unit (ICU). As with other nondepolarizing neuromuscular blocking drugs, apparent tolerance to Rocuronium Bromide Injection may develop during chronic administration in the ICU. While the mechanism for development of this resistance is not known, receptor up-regulation may be a contributing factor.

It is strongly recommended that… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS In clinical trials, the most common adverse reactions (2%) are transient hypotension and hypertension. The following adverse reactions are described, or described in greater detail, in other sections: Anaphylaxis [see Warnings and Precautions ( 5.2 )] Residual paralysis [see Warnings and Precautions ( 5.5 )] Myopathy [see Warnings and Precautions ( 5.6 )] Increased pulmonary vascular resistance [see Warnings and Precautions ( 5.12 )] Most common adverse reactions (2%) are transient hypotension and hypertension.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical studies of another rocuronium bromide injection product in the U.S. (n=1137) and Europe (n=1394) totaled 2531 patients.

The following adverse reactions were reported in patients administered another rocuronium bromide injection (all events judged by investigators during the clinical trials to have a possible causal relationship): Adverse reactions in greater than 1% of patients: None Adverse reactions in less than 1% of patients (probably related or relationship unknown): Cardiovascular: arrhythmia, abnormal electrocardiogram, tachycardia Digestive: nausea, vomiting Respiratory: asthma (bronchospasm, wheezing, or rhonchi), hiccup Skin and Appendages: rash, injection site edema, pruritus In the European studies of another rocuronium bromide injection product, the most commonly reported reactions were transient hypotension (2%) and hypertension (2%); these are in greater frequency than the US studies (0.1% and 0.1%).

Changes in heart rate and blood pressure were defined differently from in the US studies in which changes in cardiovascular parameters were not considered as adverse events unless judged by the investigator as unexpected, clinically significant, or thought to be histamine related. In a clinical study of another rocuronium bromide injection product in patients with clinically significant cardiovascular disease undergoing coronary artery bypass graft, hypertension and tachycardia were reported in some patients, but these occurrences were less frequent in patients receiving beta or calcium channel-blocking drugs.

In some patients, the use of another rocuronium bromide injection product was associated with transient increases (30% or greater) in pulmonary vascular resistance. In another clinical study of patients undergoing abdominal aortic surgery, transient increases (30% or greater) in pulmonary vascular resistance were observed in about 24% of patients who received another rocuronium bromide injection product at 0.6 or 0.9 mg/kg. In pediatric patient studies worldwide of another rocuronium bromide injection product (n=704), tachycardia occurred at an incidence of 5.3% (n=37), and it was judged by the investigator as related in 10 cases (1.4%).

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of rocuronium bromide 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. Immune system disorders: In clinical practice, there have been reports of severe allergic reactions (anaphylactic reactions and shock) with rocuronium bromide injection, including some that have been life-threatening and fatal [see Warnings and Precautions ( 5.2 )] .

General disorders and administration site conditions: There have been reports of malignant hyperthermia with the use of rocuronium bromide injection [see Warnings and Precautions ( 5.7 )].

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS Succinylcholine : Use before succinylcholine has not been studied. ( 7.11 ) Nondepolarizing muscle relaxants : Interactions have been observed. ( 7.7 ) Enhanced Rocuronium Bromide Injection activity possible : Inhalation anesthetics ( 7.3 ), certain antibiotics ( 7.1 ), quinidine ( 7.10 ), magnesium ( 7.6 ), lithium ( 7.4 ), local anesthetics ( 7.5 ), procainamide ( 7.8 ) Reduced Rocuronium Bromide Injection activity possible : Anticonvulsants.

( 7.2 )

7.1Antibiotics Drugs which may enhance the neuromuscular blocking action of nondepolarizing agents such as Rocuronium Bromide Injection include certain antibiotics (e.g., aminoglycosides; vancomycin; tetracyclines; bacitracin; polymyxins; colistin; and sodium colistimethate). If these antibiotics are used in conjunction with Rocuronium Bromide Injection, prolongation of neuromuscular block may occur.

7.2Anticonvulsants In 2 of 4 patients who received chronic anticonvulsant therapy, apparent resistance to the effects of another rocuronium bromide injection product was observed in the form of diminished magnitude of neuromuscular block or shortened clinical duration. As with other nondepolarizing neuromuscular blocking drugs, if Rocuronium Bromide Injection is administered to patients chronically receiving anticonvulsant agents such as carbamazepine or phenytoin, shorter durations of neuromuscular block may occur and infusion rates may be higher due to the development of resistance to nondepolarizing muscle relaxants.

While the mechanism for development of this resistance is not known, receptor up-regulation may be a contributing factor [see Warnings and Precautions ( 5.10 )] .

7.3Inhalation Anesthetics Use of inhalation anesthetics (enflurane > isoflurane > halothane) has been shown to enhance the activity of other neuromuscular blocking agents. Isoflurane and enflurane may also prolong the duration of action of initial and maintenance doses of Rocuronium Bromide Injection and decrease the average infusion requirement of Rocuronium Bromide Injection by 40% compared to opioid/nitrous oxide/oxygen anesthesia. No definite interaction between rocuronium bromide injection and halothane has been demonstrated.

In one study, use of enflurane in 10 patients who received another rocuronium bromide injection product resulted in a 20% increase in mean clinical duration of the initial intubating dose, and a 37% increase in the duration of subsequent maintenance doses, when compared in the same study to 10 patients under opioid/nitrous oxide/oxygen anesthesia. The clinical duration of initial doses of another rocuronium bromide injection product (0.57 to 0.85 mg/kg) under enflurane or isoflurane anesthesia, as used clinically, was increased by 11% and 23%, respectively.

The duration of maintenance doses was affected to a greater extent, increasing by 30% to 50% under either enflurane or isoflurane anesthesia. Potentiation by these agents was also observed with respect to the infusion rates of rocuronium bromide injection required to maintain approximately 95% neuromuscular block. Under isoflurane and enflurane anesthesia, the infusion rates were decreased by approximately 40% compared to opioid/nitrous oxide/oxygen anesthesia.

The median spontaneous recovery time (from 25% to 75% of control T1) was not affected by halothane but is prolonged by enflurane (15% longer) and isoflurane (62% longer). Reversal-induced recovery of Rocuronium Bromide Injection neuromuscular block is minimally affected by anesthetic technique [see Dosage and Administration ( 2.6 ) and Warnings and Precautions ( 5.10 )] .

7.4Lithium Carbonate Lithium has been shown to increase the duration of neuromuscular block and decrease infusion requirements of neuromuscular blocking agents [see Warnings and Precautions ( 5.10 )] .

7.5Local Anesthetics Local anesthetics have been shown to increase the duration of neuromuscular block and decrease infusion requirements of neuromuscular blocking agents [see War… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy : Not recommended for rapid sequence induction in patients undergoing Cesarean section. ( 8.1 , 14.1 ) Pediatric Use : Onset time and duration will vary with dose, age, and anesthetic technique. Not recommended for rapid sequence intubation in pediatric patients. ( 8.4 )

8.1Pregnancy Risk Summary Available data from controlled trials and case series and over decades of use of rocuronium bromide in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are potential risks when rocuronium bromide is used during labor or delivery (see Clinical Considerations ). Based on data from umbilical cord blood sampling, rocuronium bromide is transferred across the placenta [see Clinical Studies ( 14.1 )] .

In animal reproduction studies, there was no evidence of teratogenicity when rocuronium bromide was administered intravenously to pregnant, conscious, nonventilated rats and rabbits at 15%-30% and 25%, respectively, the human intubation dose of 0.6-1.2 mg/kg during the period of organogenesis (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Labor or Delivery: Magnesium sulfate used in the management of pre-eclampsia or eclampsia in pregnancy may enhance neuromuscular blockade [see Warning and Precautions 5.10 ]. The use of another rocuronium bromide injection product in Cesarean section has been studied in a limited number of patients.

Adverse events in this study included low APGAR scores in neonates at 5 minutes and poor intubation conditions in some pregnant women who received rocuronium bromide [see Clinical Studies ( 14.1 )] . Rocuronium Bromide Injection is not recommended for rapid sequence induction in Cesarean section patients. Data Animal Data: Developmental toxicology studies have been performed with rocuronium bromide in pregnant, conscious, nonventilated rabbits and rats.

Inhibition of neuromuscular function was the endpoint for high-dose selection. The maximum tolerated dose served as the high dose and was administered intravenously 3 times a day to rats (0.3 mg/kg, 15%-30% of human intubation dose of 0.6-1.2 mg/kg based on the body surface unit of mg/m 2 ) from Day 6 to 17 and to rabbits (0.02 mg/kg, 25% human dose) from Day 6 to 18 of pregnancy. High-dose treatment caused acute symptoms of respiratory dysfunction due to the pharmacological activity of the drug.

Teratogenicity was not observed in these animal species. The incidence of late embryonic death was increased at the high dose in rats, most likely due to oxygen deficiency. Therefore, this finding probably has no relevance for humans because immediate mechanical ventilation of the intubated patient will effectively prevent embryo-fetal hypoxia.

8.2Lactation Risk Summary There are no available data on the presence of rocuronium bromide in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for rocuronium bromide and any potential adverse effects on the breastfed child from rocuronium bromide or from the underlying maternal condition.

8.4Pediatric Use The use of another rocuronium bromide injection product has been studied in pediatric patients 3 months to 14 years of age under halothane anesthesia. Of the pediatric patients anesthetized with halothane who did not receive atropine for induction, about 80% experienced a transient increase (30% or greater) in heart rate after intubation. One of the 19 infants anesthetized with halothane and fentanyl… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Available data from controlled trials and case series and over decades of use of rocuronium bromide in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are potential risks when rocuronium bromide is used during labor or delivery (see Clinical Considerations ). Based on data from umbilical cord blood sampling, rocuronium bromide is transferred across the placenta [see Clinical Studies ( 14.1 )] .

In animal reproduction studies, there was no evidence of teratogenicity when rocuronium bromide was administered intravenously to pregnant, conscious, nonventilated rats and rabbits at 15%-30% and 25%, respectively, the human intubation dose of 0.6-1.2 mg/kg during the period of organogenesis (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Labor or Delivery: Magnesium sulfate used in the management of pre-eclampsia or eclampsia in pregnancy may enhance neuromuscular blockade [see Warning and Precautions 5.10 ]. The use of another rocuronium bromide injection product in Cesarean section has been studied in a limited number of patients.

Adverse events in this study included low APGAR scores in neonates at 5 minutes and poor intubation conditions in some pregnant women who received rocuronium bromide [see Clinical Studies ( 14.1 )] . Rocuronium Bromide Injection is not recommended for rapid sequence induction in Cesarean section patients. Data Animal Data: Developmental toxicology studies have been performed with rocuronium bromide in pregnant, conscious, nonventilated rabbits and rats.

Inhibition of neuromuscular function was the endpoint for high-dose selection. The maximum tolerated dose served as the high dose and was administered intravenously 3 times a day to rats (0.3 mg/kg, 15%-30% of human intubation dose of 0.6-1.2 mg/kg based on the body surface unit of mg/m 2 ) from Day 6 to 17 and to rabbits (0.02 mg/kg, 25% human dose) from Day 6 to 18 of pregnancy. High-dose treatment caused acute symptoms of respiratory dysfunction due to the pharmacological activity of the drug.

Teratogenicity was not observed in these animal species. The incidence of late embryonic death was increased at the high dose in rats, most likely due to oxygen deficiency. Therefore, this finding probably has no relevance for humans because immediate mechanical ventilation of the intubated patient will effectively prevent embryo-fetal hypoxia.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The use of another rocuronium bromide injection product has been studied in pediatric patients 3 months to 14 years of age under halothane anesthesia. Of the pediatric patients anesthetized with halothane who did not receive atropine for induction, about 80% experienced a transient increase (30% or greater) in heart rate after intubation. One of the 19 infants anesthetized with halothane and fentanyl who received atropine for induction experienced this magnitude of change [see Dosage and Administration ( 2.6 ), Clinical Studies ( 14.3 )] .

Another rocuronium bromide injection product was also studied in pediatric patients up to 17 years of age, including neonates, under sevoflurane (induction) and isoflurane/nitrous oxide (maintenance) anesthesia. Onset time and clinical duration varied with dose, the age of the patient, and anesthetic technique. The overall analysis of ECG data in pediatric patients indicated that the concomitant use of Rocuronium Bromide Injection with general anesthetic agents can prolong the QTc interval.

The data also suggest that Rocuronium Bromide Injection may increase heart rate. However, it was not possible to conclusively identify an effect of rocuronium bromide independent of that of anesthesia and other factors. Additionally, when examining plasma levels of rocuronium bromide in correlation to QTc interval prolongation, no relationship was observed [see Dosage and Administration ( 2.6 ), Warnings and Precautions ( 5.9 ), Clinical Studies ( 14.3 )].

Rocuronium Bromide Injection is not recommended for rapid sequence intubation in pediatric patients. Recommendations for use in pediatric patients are discussed in other sections of labeling [see Dosage and Administration ( 2.6 ) Clinical Pharmacology ( 12.2 )] .

🧓 Geriatric Use 123 words ▾

8.5Geriatric Use Another rocuronium bromide injection product was administered to 140 geriatric patients (65 years of age or older) in U.S. clinical trials and 128 geriatric patients in European clinical trials. The observed pharmacokinetic profile of rocuronium bromide for geriatric patients (n=20) was similar to that for other adult surgical patients [see Clinical Pharmacology ( 12.3 )] . However, onset time and duration of action of rocuronium bromide were slightly longer for geriatric patients (n=43) in clinical trials.

Clinical experiences and recommendations for use of Rocuronium Bromide Injection in geriatric patients are discussed in other sections of the labeling [see Dosage and Administration ( 2.6 ), Warnings and Precautions ( 5.5 ), Clinical Pharmacology ( 12.2 ), Clinical Studies ( 14.2 )].

🆘 Overdosage 174 words ▾

10 OVERDOSAGE Overdosage with neuromuscular blocking agents may result in neuromuscular block beyond the time needed for surgery and anesthesia. The primary treatment is maintenance of a patent airway, controlled ventilation, and adequate sedation until recovery of normal neuromuscular function is assured. Once evidence of recovery from neuromuscular block is observed, further recovery may be facilitated by administration of an anticholinesterase agent in conjunction with an appropriate anticholinergic agent.

Reversal of Neuromuscular Blockade: Anticholinesterase agents should not be administered prior to the demonstration of some spontaneous recovery from neuromuscular blockade. The use of a nerve stimulator to document recovery is recommended. Patients should be evaluated for adequate clinical evidence of neuromuscular recovery, e.g., 5-second head lift, adequate phonation, ventilation, and upper airway patency.

Ventilation must be supported while patients exhibit any signs of muscle weakness. Recovery may be delayed in the presence of debilitation, carcinomatosis, and concomitant use of certain drugs which enhance neuromuscular blockade or separately cause respiratory depression. Under such circumstances the management is the same as that of prolonged neuromuscular blockade.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Rocuronium Bromide Injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. It acts by competing for cholinergic receptors at the motor end-plate. This action is antagonized by acetylcholinesterase inhibitors, such as neostigmine and edrophonium.

12.2Pharmacodynamics The Rocuronium Bromide Injection dose required to produce 95% suppression (ED95) of the first [T1] mechanomyographic [MMG] response of the adductor pollicis muscle [thumb] to indirect supramaximal train-of-four stimulation of the ulnar nerve) during opioid/nitrous oxide/oxygen anesthesia is approximately 0.3 mg/kg. Patient variability around the ED95 dose suggests that 50% of patients will exhibit T1 depression of 91% to 97%. Table 4 presents intubating conditions in patients with intubation initiated at 60 to 70 seconds.

Table 4: Percent of Excellent or Good Intubating Conditions and Median (Range) Time to Completion of Intubation in Patients with Intubation Initiated at 60 to 70 Seconds * Excludes patients undergoing Cesarean section. † Pediatric patients were under halothane anesthesia. Excellent intubating conditions=jaw relaxed, vocal cords apart and immobile, no diaphragmatic movement. Good intubating conditions=same as excellent but with some diaphragmatic movement. rocuronium bromide injection Dose (mg/kg) Administered Over 5 sec Percent of Patients with Excellent or Good Intubating Conditions Time to Completion of Intubation (min) Adults* 18 to 64 yrs 0.45 (n=43) 0.6 (n=51) 86% 96% 1.6 (1.0-7.0) 1.6 (1.0-3.2) Infants † 3 mo to 1 yr 0.6 (n=18) 100% 1.0 (1.0-1.5) Pediatric † 1 to 12 yrs 0.6 (n=12) 100% 1.0 (0.5-2.3) Table 5 presents the time to onset and clinical duration for the initial dose of Rocuronium Bromide Injection under opioid/nitrous oxide/oxygen anesthesia in adults and geriatric patients, and under halothane anesthesia in pediatric patients.

Table 5: Median (Range) Time to Onset and Clinical Duration Following Initial (Intubating) Dose During Opioid/Nitrous Oxide/Oxygen Anesthesia (Adults) and Halothane Anesthesia (Pediatric Patients) n=the number of patients who had time to maximum block recorded. Clinical duration=time until return to 25% of control T 1 . Patients receiving doses of 0.45 mg/kg who achieved less than 90% block (16% of these patients) had about 12 to 15 minutes to 25% recovery. rocuronium bromide injection Dose (mg/kg) Administered Over 5 sec Time to ≥80% Block (min) Time to Maximum Block (min) Clinical Duration (min) Adults 18 to 64 yrs 1.3 (0.8-6.2) 3.0 (1.3-8.2) 22 (12-31) 0.45 (n=50) 0.6 (n=142) 1.0 (0.4-6.0) 1.8 (0.6-13.0) 31 (15-85) 0.9 (n=20) 1.1 (0.3-3.8) 1.4 (0.8-6.2) 58 (27-111) 1.2 (n=18) 0.7 (0.4-1.7) 1.0 (0.6-4.7) 67 (38-160) Geriatric ≥65 yrs 2.3 (1.0-8.3) 3.7 (1.3-11.3) 46 (22-73) 0.6 (n=31) 0.9 (n=5) 2.0 (1.0-3.0) 2.5 (1.2-5.0) 62 (49-75) 1.2 (n=7) 1.0 (0.8-3.5) 1.3 (1.2-4.7) 94 (64-138) Infants 3 mo to 1 yr 0.6 (n=17) 0.8 (n=9) — — 0.8 (0.3-3.0) 0.7 (0.5-0.8) 41 (24-68) 40 (27-70) Pediatric 1 to 12 yrs 0.6 (n=27) 0.8 (n=18) 0.8 (0.4-2.0) — 1.0 (0.5-3.3) 0.5 (0.3-1.0) 26 (17-39) 30 (17-56) Table 6 presents the time to onset and clinical duration for the initial dose of Rocuronium Bromide Injection (rocuronium bromide) Injection under sevoflurane (induction) and isoflurane/nitrous oxide (maintenance) anesthesia in pediatric patients.

Table 6: Median (Range) Time to Onset and Clinical Duration Following Initial (Intubating) Dose During Sevoflurane (induction) and Isoflurane/Nitrous Oxide (maintenance) Anesthesia (Pediatric Patients) n=the number of patients with the highest number of observations for time to maximum block or reappearance T 3 . rocuronium bromide injection Dose (mg/kg) Administered Over 5 sec Time to Maximum Block (min) Time to Reappearance T 3 (min) Neonates birth to <28 days 1.1 (0.6-2.2) 40.3 (32.5-62.6) 0.45 (n=5) 0.6 (n=10) 1.0 (0.2-2.1) 49.7 (16.6-119.0) 1 (n=6… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 48 words ▾

12.1Mechanism of Action Rocuronium Bromide Injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. It acts by competing for cholinergic receptors at the motor end-plate. This action is antagonized by acetylcholinesterase inhibitors, such as neostigmine and edrophonium.

📦 How Supplied / Storage and Handling 193 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Rocuronium Bromide Injection is a clear, colorless to yellow/orange solution, free from visible particulate matter and available in single-dose vials in the following packaging configurations: Product Code Unit of Sale Strength Each 442105 NDC 65219-442-05 Unit of 10 50 mg per 5 mL (10 mg per mL) NDC 65219-442-02 Single-Dose Vial RF442105 NDC 65219-695-05 Unit of 10 50 mg per 5 mL (10 mg per mL) NDC 65219-695-01 Single-Dose Vial This product is RFID-enabled. 442110 NDC 65219-444-10 Unit of 10 100 mg per 10 mL (10 mg per mL) NDC 65219-444-04 Single-Dose Vial RF442110 NDC 65219-697-10 Unit of 10 100 mg per 10 mL (10 mg per mL) NDC 65219-697-01 Single-Dose Vial This product is RFID-enabled.

The container closure is not made with natural rubber latex. Rocuronium Bromide Injection should be stored at 20°C to 25°C (68°F to 77°F); Excursion permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. DO NOT FREEZE.

Safety and Handling There is no specific work exposure limit for Rocuronium Bromide Injection. In case of eye contact, flush with water for at least 10 minutes. Single-Dose Vial.

Discard Unused Portion.

📋 Description 153 words ▾

11 DESCRIPTION Rocuronium bromide is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17β-(acetyloxy)-3α-hydroxy-2β-(4-morpholinyl)-5α-androstan-16β-yl]-1-(2-propenyl) pyrrolidinium bromide. The structural formula is: Rocuronium bromide USP is an almost white to pale yellow, hygroscopic powder.

Rocuronium bromide is soluble in water and dichloromethane, slightly soluble in ethanol and methanol. The chemical formula is C 32 H 53 BrN 2 O 4 with a molecular weight of 609.70. The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20°C.

Rocuronium Bromide Injection is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellow/orange, for intravenous use only. Each mL contains 10 mg rocuronium bromide (equivalent to 8.69 mg of rocuronium) and inactive ingredients 17.1 mcL hydrochloric acid, 8 mg sodium chloride. The solution pH is adjusted to 2.8 to 3.2 with hydrochloric acid and/or sodium hydroxide.

Structural Formula

💬 Information for Patients 114 words ▾

17 PATIENT COUNSELING INFORMATION Obtain information about your patient's medical history, current medications, any history of hypersensitivity to rocuronium bromide or other neuromuscular blocking agents. If applicable, inform your patients that certain medical conditions and medications might influence how Rocuronium Bromide Injection works [see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7 )] . In addition, inform your patient that severe anaphylactic reactions to neuromuscular blocking agents, including Rocuronium Bromide Injection, have been reported.

Because allergic cross-reactivity has been reported in this class, request information from your patients about previous anaphylactic reactions to other neuromuscular blocking agents [see Warnings and Precautions ( 5.2 )] . Manufactured by: www.fresenius-kabi.com/us 451851 Fresenius Kabi Logo

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Adult and Geriatric Patients In an effort to maximize the information gathered in the in vivo pharmacokinetic studies, the data from the studies was used to develop population estimates of the parameters for the subpopulations represented (e.g., geriatric, pediatric, renal, and hepatic impairment). These population-based estimates and a measure of the estimate variability are contained in the following section. Following intravenous administration of rocuronium bromide injection, plasma levels of rocuronium follow a three-compartment open model.

The rapid distribution half-life is 1 to 2 minutes and the slower distribution half-life is 14 to 18 minutes. Rocuronium is approximately 30% bound to human plasma proteins. In geriatric and other adult surgical patients undergoing either opioid/nitrous oxide/oxygen or inhalational anesthesia, the observed pharmacokinetic profile was essentially unchanged [see Dosage and Administration ( 2.6 )] .

Table 7: Mean (SD) Pharmacokinetic Parameters in Adults (n=22; ages 27 to 58 yrs) and Geriatric (n=20; 65 yrs or greater) During Opioid/Nitrous Oxide/Oxygen Anesthesia PK Parameters Adults (Ages 27-58 yrs) Geriatrics (≥65 yrs) Clearance (L/kg/hr) 0.25 (0.08) 0.21 (0.06) Volume of Distribution at Steady State (L/kg) 0.25 (0.04) 0.22 (0.03) t 1/2 β Elimination (hr) 1.4 (0.4) 1.5 (0.4) In general, studies with normal adult subjects did not reveal any differences in the pharmacokinetics of rocuronium due to gender. Studies of distribution, metabolism, and excretion in cats and dogs indicate that rocuronium is eliminated primarily by the liver.

The rocuronium analog 17-desacetyl-rocuronium, a metabolite, has been rarely observed in the plasma or urine of humans administered single doses of 0.5 to 1 mg/kg with or without a subsequent infusion (for up to 12 hr) of rocuronium. In the cat, 17-desacetyl-rocuronium has approximately one-twentieth the neuromuscular blocking potency of rocuronium. The effects of renal failure and hepatic disease on the pharmacokinetics and pharmacodynamics of rocuronium in humans are consistent with these findings.

In general, patients undergoing cadaver kidney transplant have a small reduction in clearance which is offset pharmacokinetically by a corresponding increase in volume, such that the net effect is an unchanged plasma half-life. Patients with demonstrated liver cirrhosis have a marked increase in their volume of distribution resulting in a plasma half- life approximately twice that of patients with normal hepatic function. Table 8 shows the pharmacokinetic parameters in subjects with either impaired renal or hepatic function.

Table 8: Mean (SD) Pharmacokinetic Parameters in Adults with Normal Renal and Hepatic Function (n=10, ages 23 to 65), Renal Transplant Patients (n=10, ages 21 to 45), and Hepatic Dysfunction Patients (n=9, ages 31 to 67) During Isoflurane Anesthesia * Differences in the calculated t 1/2 β and Cl between this study and the study in young adults vs. geriatrics (≥65 years) is related to the different sample populations and anesthetic techniques. PK Parameters Normal Renal and Hepatic Function Renal Transplant Patients Hepatic Dysfunction Patients Clearance (L/kg/hr) 0.16 (0.05)* 0.13 (0.04) 0.13 (0.06) Volume of Distribution at Steady State (L/kg) 0.26 (0.03) 0.34 (0.11) 0.53 (0.14) t 1/2 β Elimination (hr) 2.4 (0.8)* 2.4 (1.1) 4.3 (2.6) The net result of these findings is that subjects with renal failure have clinical durations that are similar to but somewhat more variable than the duration that one would expect in subjects with normal renal function.

Hepatically impaired patients, due to the large increase in volume, may demonstrate clinical durations approaching 1.5 times that of subjects with normal hepatic function. In both populations the clinician should individualize the dose to the needs of the patient [see Dosage and Administration ( 2.6 )] . Tissue redistribution accounts for most (about 80%) of the initial amo… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~3 min read ▾

12.2Pharmacodynamics The Rocuronium Bromide Injection dose required to produce 95% suppression (ED95) of the first [T1] mechanomyographic [MMG] response of the adductor pollicis muscle [thumb] to indirect supramaximal train-of-four stimulation of the ulnar nerve) during opioid/nitrous oxide/oxygen anesthesia is approximately 0.3 mg/kg. Patient variability around the ED95 dose suggests that 50% of patients will exhibit T1 depression of 91% to 97%. Table 4 presents intubating conditions in patients with intubation initiated at 60 to 70 seconds.

Table 4: Percent of Excellent or Good Intubating Conditions and Median (Range) Time to Completion of Intubation in Patients with Intubation Initiated at 60 to 70 Seconds * Excludes patients undergoing Cesarean section. † Pediatric patients were under halothane anesthesia. Excellent intubating conditions=jaw relaxed, vocal cords apart and immobile, no diaphragmatic movement. Good intubating conditions=same as excellent but with some diaphragmatic movement. rocuronium bromide injection Dose (mg/kg) Administered Over 5 sec Percent of Patients with Excellent or Good Intubating Conditions Time to Completion of Intubation (min) Adults* 18 to 64 yrs 0.45 (n=43) 0.6 (n=51) 86% 96% 1.6 (1.0-7.0) 1.6 (1.0-3.2) Infants † 3 mo to 1 yr 0.6 (n=18) 100% 1.0 (1.0-1.5) Pediatric † 1 to 12 yrs 0.6 (n=12) 100% 1.0 (0.5-2.3) Table 5 presents the time to onset and clinical duration for the initial dose of Rocuronium Bromide Injection under opioid/nitrous oxide/oxygen anesthesia in adults and geriatric patients, and under halothane anesthesia in pediatric patients.

Table 5: Median (Range) Time to Onset and Clinical Duration Following Initial (Intubating) Dose During Opioid/Nitrous Oxide/Oxygen Anesthesia (Adults) and Halothane Anesthesia (Pediatric Patients) n=the number of patients who had time to maximum block recorded. Clinical duration=time until return to 25% of control T 1 . Patients receiving doses of 0.45 mg/kg who achieved less than 90% block (16% of these patients) had about 12 to 15 minutes to 25% recovery. rocuronium bromide injection Dose (mg/kg) Administered Over 5 sec Time to ≥80% Block (min) Time to Maximum Block (min) Clinical Duration (min) Adults 18 to 64 yrs 1.3 (0.8-6.2) 3.0 (1.3-8.2) 22 (12-31) 0.45 (n=50) 0.6 (n=142) 1.0 (0.4-6.0) 1.8 (0.6-13.0) 31 (15-85) 0.9 (n=20) 1.1 (0.3-3.8) 1.4 (0.8-6.2) 58 (27-111) 1.2 (n=18) 0.7 (0.4-1.7) 1.0 (0.6-4.7) 67 (38-160) Geriatric ≥65 yrs 2.3 (1.0-8.3) 3.7 (1.3-11.3) 46 (22-73) 0.6 (n=31) 0.9 (n=5) 2.0 (1.0-3.0) 2.5 (1.2-5.0) 62 (49-75) 1.2 (n=7) 1.0 (0.8-3.5) 1.3 (1.2-4.7) 94 (64-138) Infants 3 mo to 1 yr 0.6 (n=17) 0.8 (n=9) — — 0.8 (0.3-3.0) 0.7 (0.5-0.8) 41 (24-68) 40 (27-70) Pediatric 1 to 12 yrs 0.6 (n=27) 0.8 (n=18) 0.8 (0.4-2.0) — 1.0 (0.5-3.3) 0.5 (0.3-1.0) 26 (17-39) 30 (17-56) Table 6 presents the time to onset and clinical duration for the initial dose of Rocuronium Bromide Injection (rocuronium bromide) Injection under sevoflurane (induction) and isoflurane/nitrous oxide (maintenance) anesthesia in pediatric patients.

Table 6: Median (Range) Time to Onset and Clinical Duration Following Initial (Intubating) Dose During Sevoflurane (induction) and Isoflurane/Nitrous Oxide (maintenance) Anesthesia (Pediatric Patients) n=the number of patients with the highest number of observations for time to maximum block or reappearance T 3 . rocuronium bromide injection Dose (mg/kg) Administered Over 5 sec Time to Maximum Block (min) Time to Reappearance T 3 (min) Neonates birth to <28 days 1.1 (0.6-2.2) 40.3 (32.5-62.6) 0.45 (n=5) 0.6 (n=10) 1.0 (0.2-2.1) 49.7 (16.6-119.0) 1 (n=6) 0.6 (0.3-1.8) 114.4 (92.6-136.3) Infants 28 days to ≤3 mo 0.5 (0.4-1.3) 49.1 (13.5-79.9) 0.45 (n=9) 0.6 (n=11) 0.4 (0.2-0.8) 59.8 (32.3-87.8) 1 (n=5) 0.3 (0.2-0.7) 103.3 (90.8-155.4) Toddlers >3 mo to ≤2 yrs 0.8 (0.3-1.9) 39.2 (16.9-59.4) 0.45 (n=17) 0.6 (n=29) 0.6 (0.2-1.6) 44.2 (18.9-68.8) 1 (n=15) 0.5 (0.2-1.5) 72.0 (36.2-128.2) Children >2 yrs to ≤11 yrs 0.9 (0.4-1.9) 21.… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The effectiveness of Rocuronium Bromide Injection has been established based on adequate and well-controlled studies of another formulation of rocuronium bromide injection in adult patients. Below is a display of the efficacy results of the adequate and well-controlled studies of the other formulation of rocuronium bromide injection. In US clinical studies, a total of 1137 patients received another rocuronium bromide injection, product, including 176 pediatric, 140 geriatric, 55 obstetric, and 766 other adults.

Most patients (90%) were ASA physical status I or II, about 9% were ASA III, and 10 patients (undergoing coronary artery bypass grafting or valvular surgery) were ASA IV. In European clinical studies, a total of 1394 patients received rocuronium bromide injection, including 52 pediatric, 128 geriatric (65 years or greater), and 1214 other adults.

14.1Adult Patients Intubation using doses of rocuronium bromide injection 0.6 to 0.85 mg/kg was evaluated in 203 adults in 11 clinical studies. Excellent to good intubating conditions were generally achieved within 2 minutes and maximum block occurred within 3 minutes in most patients. Doses within this range provide clinical relaxation for a median (range) time of 33 (14-85) minutes under opioid/nitrous oxide/oxygen anesthesia.

Larger doses (0.9 and 1.2 mg/kg) were evaluated in 2 studies with 19 and 16 patients under opioid/nitrous oxide/oxygen anesthesia and provided 58 (27-111) and 67 (38-160) minutes of clinical relaxation, respectively. Cardiovascular Disease In 1 clinical study, 10 patients with clinically significant cardiovascular disease undergoing coronary artery bypass graft received an initial dose of 0.6 mg/kg rocuronium bromide injection. Neuromuscular block was maintained during surgery with bolus maintenance doses of 0.3 mg/kg.

Following induction, continuous 8 mcg/kg/min infusion of rocuronium bromide injection produced relaxation sufficient to support mechanical ventilation for 6 to 12 hours in the surgical intensive care unit (SICU) while the patients were recovering from surgery. Rapid Sequence Intubation Intubation was assessed in patients in 6 clinical studies where anesthesia was induced with either thiopental (3-6 mg/kg) or propofol (1.5-2.5 mg/kg) in combination with either fentanyl (2-5 mcg/kg) or alfentanil (1 mg). Most of the patients also received a premedication such as midazolam or temazepam.

Most patients had intubation attempted within 60 to 90 seconds of administration of rocuronium bromide injection 0.6 mg/kg or succinylcholine 1 to 1.5 mg/kg. Excellent or good intubating conditions were achieved in 119/120 (99% [95% confidence interval: 95%-99.9%]) patients receiving Rocuronium Bromide Injection and in 108/110 (98% [94%-99.8%]) patients receiving succinylcholine. The duration of action of Rocuronium Bromide Injection 0.6 mg/kg is longer than succinylcholine and at this dose is approximately equivalent to the duration of other intermediate- acting neuromuscular blocking drugs.

Obese Patients Rocuronium bromide injection was dosed according to actual body weight (ABW) in most clinical studies. The administration of rocuronium bromide injection in the 47 of 330 (14%) patients who were at least 30% or more above their ideal body weight (IBW) was not associated with clinically significant differences in the onset, duration, recovery, or reversal of rocuronium bromide injection-induced neuromuscular block. In 1 clinical study in obese patients, rocuronium bromide injection 0.6 mg/kg was dosed according to ABW (n=12) or IBW (n=11).

Obese patients dosed according to IBW had a longer time to maximum block, a shorter median (range) clinical duration of 25 (14-29) minutes, and did not achieve intubating conditions comparable to those dosed based on ABW. These results support the recommendation that obese patients be dosed based on actual body weight [see Dosage and Administration ( 2.6 )] . Obstetric Patients Rocuronium bromide inje… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 50 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Studies in animals have not been performed with rocuronium bromide to evaluate carcinogenic potential or impairment of fertility. Mutagenicity studies (Ames test, analysis of chromosomal aberrations in mammalian cells, and micronucleus test) conducted with rocuronium bromide did not suggest mutagenic potential.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 47 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Studies in animals have not been performed with rocuronium bromide to evaluate carcinogenic potential or impairment of fertility. Mutagenicity studies (Ames test, analysis of chromosomal aberrations in mammalian cells, and micronucleus test) conducted with rocuronium bromide did not suggest mutagenic potential.

📄 Package Label / Principal Display Panel ~2 min read ▾

PACKAGE LABEL - PRINCIPAL DISPLAY - Rocuronium 5 mL Single-Dose Vial Label NDC 65219-442-02 5 mL Single-Dose Vial. Discard Unused Portion Rocuronium Bromide Injection 50 mg per 5 mL (10 mg per mL) WARNING: Paralyzing Agent For intravenous use only Rx only vial

PACKAGE LABEL - PRINCIPAL DISPLAY - Rocuronium 5 mL Single-Dose Vial Tray Label NDC 65219-442-05 Rocuronium Bromide Injection 50 mg per 5 mL (10 mg per mL) WARNING: Paralyzing Agent For intravenous use only 10 x 5 mL Single-Dose Vials. Discard Unused Portion Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Rocuronium 5 mL Single-Dose Vial Tray

PACKAGE LABEL - PRINCIPAL DISPLAY - Rocuronium 10 mL Single-Dose Vial Label NDC 65219-444-04 10 mL Single-Dose Vial. Discard Unused Portion Rocuronium Bromide Injection 100 mg per 10 mL (10 mg per mL) WARNING: Paralyzing Agent For intravenous use only Rx only 100vial

PACKAGE LABEL - PRINCIPAL DISPLAY - Rocuronium 10 mL Single-Dose Vial Tray Label NDC 65219-444-10 Rocuronium Bromide Injection 100 mg per 10 mL (10 mg per mL) WARNING: Paralyzing Agent For intravenous use only 10 x 10 mL Single-Dose Vials. Discard Unused Portion Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Rocuronium 10 mL Single-Dose Vial

PACKAGE LABEL - PRINCIPAL DISPLAY - Rocuronium 5 mL Single-Dose Vial Label NDC 65219-695-01 5 mL Single-Dose Vial. Discard Unused Portion Rocuronium Bromide Injection 50 mg per 5 mL (10 mg per mL) WARNING: Paralyzing Agent For intravenous use only Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Rocuronium 5 mL Single-Dose Vial Label

PACKAGE LABEL - PRINCIPAL DISPLAY - Rocuronium 5 mL Single-Dose Vial Tray Label NDC 65219-695-05 Rocuronium Bromide Injection 50 mg per 5 mL (10 mg per mL) WARNING: Paralyzing Agent For intravenous use only 10 x 5 mL Single-Dose Vials. Discard Unused Portion PACKAGE LABEL - PRINCIPAL DISPLAY - Rocuronium 5 mL Single-Dose Vial Tray Label

PACKAGE LABEL - PRINCIPAL DISPLAY - Rocuronium 10 mL Single-Dose Vial Label NDC 65219-697-01 10 mL Single-Dose Vial. Discard Unused Portion Rocuronium Bromide Injection 100 mg per 10 mL (10 mg per mL) WARNING: Paralyzing Agent For intravenous use only Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Rocuronium 10 mL Single-Dose Vial Label

PACKAGE LABEL - PRINCIPAL DISPLAY - Rocuronium 10 mL Single-Dose Vial Tray Label NDC 65219-697-10 Rocuronium Bromide Injection 100 mg per 10 mL (10 mg per mL) WARNING: Paralyzing Agent For intravenous use only 10 x 10 mL Single-Dose Vials. Discard Unused Portion PACKAGE LABEL - PRINCIPAL DISPLAY - Rocuronium 10 mL Single-Dose Vial Tray Label

PACKAGE LABEL - PRINCIPAL DISPLAY - Sticker Label PARALYZING AGENT Rocuronium Bromide Injection __ mg per __mL (10 mg per mL) For intravenous use only Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Sticker Label

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

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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 Fresenius Kabi USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Fresenius Kabi USA, LLC 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.
← 65219-0695-05 · Fresenius 65219-0800-10 · Fresenius →
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.