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SUCCINYLCHOLINE CHLORIDE 20 mg/mL Injection, Solution

by Henry Schein, Inc. · 1 VIAL, MULTI-DOSE in 1 BAG (0404-9983-20) / 10 mL in 1 VIAL, MULTI-DOSE
NDC 00404-9983-20
🏷️ FDA NDC (as labeled) 0404-9983-20 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Succinylcholine Chloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 27, 2025 — Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity. (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0623-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 0404-9983-20
Product NDC 0404-9983
11-digit billing NDC 00404998320
RxCUI 1594589
UNII I9L0DDD30I
Application # ANDA213810
SPL Set ID 7d0f0431-e616-49c2-80d8-0752a45428db
Established class (EPC) Depolarizing Neuromuscular Blocker
Physiologic effect Neuromuscular Depolarizing Blockade
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-07-22
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance SUCCINYLCHOLINE CHLORIDE
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 0404-9983-20 — 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 → 00404-9983-20. 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 Depolarizing Neuromuscular Blocker class.

Pharmacologic class Depolarizing Neuromuscular Blocker
Drug family (ATC) Choline derivatives
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.

🏭 Manufacturer & labeler

LabelerHenry Schein, Inc.
Application holderASPIRO PHARMA LTD
FDA applicationANDA213810 (ANDA)
Labeler code00404
First marketedJul 2022
Product typeHuman Prescription Drug
Portfolio172 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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Succinylcholine temporarily relaxes all your skeletal muscles — including the muscles in your throat and airway — so that the anesthesia team can quickly and safely place a breathi...
  • What exactly does succinylcholine do, and why would I need it?
  • No — succinylcholine only relaxes your muscles. It has no effect on your consciousness or your ability to feel pain. You would always be under general anesthesia when this drug is...
  • Will I be awake or feel anything while succinylcholine is working?
📖 Read our full Succinylcholine 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.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 1.8 mg / 1 mL UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • 0.2 mg / 1 mL UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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.

💲 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Succinylcholine Chloride 20 mg/mL 00143-9338-25 Hikma 25 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mLthis 00404-9983-20 Henry 1 vial — AP FDA listed —
Quelicin 20 mg/mL 00409-6629-02 Hospira, 25 vials — AP FDA listed —
Anectine 20 mg/mL 00781-3411-95 Sandoz 10 vials — AP FDA listed —
Anectine 20 mg/mL 00781-9053-95 Sandoz 10 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 14445-0407-25 Indoco 25 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 31722-0981-31 Camber 25 vials — AP FDA listed —
Succinylcholine Chloride 200 mg/10mL 42571-0371-87 Micro 25 vials — AP FDA listed —
Succinylcholine 20 mg/mL 43598-0666-25 Dr.Reddy's 25 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 51662-1525-01 HF 10 ml — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 55150-0315-25 Eugia 25 vials — — FDA listed —
Succinylcholine Chloride 20 mg/mL 63323-0943-10 Fresenius 25 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 66794-0232-42 Piramal 25 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 68083-0450-25 Gland 25 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 69918-0700-11 Nordic 10 vials — AP Discontinued —
Succinylcholine Chloride 20 mg/mL 70069-0301-25 Somerset 25 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 70069-0783-10 Somerset 10 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 70121-1581-05 Amneal 25 vials — — Discontinued —
Succinylcholine Chloride 20 mg/mL 70518-4409-00 REMEDYREPACK 10 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 70710-1377-02 Zydus 25 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 70756-0613-10 Lifestar 10 vials — — FDA listed —
Succinylcholine Chloride 20 mg/mL 70771-1352-07 Zydus 25 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 71288-0719-11 Meitheal 25 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 71839-0121-25 BE 25 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 71872-7166-01 Medical 1 vial — — FDA listed —
Succinylcholine Chloride 20 mg/mL 71872-7167-01 Medical 1 vial — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 71872-7221-01 Medical 1 vial — AP FDA listed —
Succinylcholine 20 mg/mL 71872-7241-01 Medical 1 vial — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 71872-7272-01 Medical 1 vial — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 71872-7275-01 Medical 1 vial — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 71872-7279-01 Medical 1 vial — AP FDA listed —
Anectine 20 mg/mL 72572-0750-10 Civica, 10 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 73043-0021-01 Devatis, 25 vials — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 84549-0301-25 ProPharma 10 ml — AP FDA listed —
Succinylcholine Chloride 20 mg/mL 82449-0232-02 STERISCIENCE 10 syringes — 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

🏛️
2022
On the market since
Jul 2022
📍
2026
Currently FDA-listed
4 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00404-9983-20 You're viewing this 1 VIAL, MULTI-DOSE in 1 BAG (0404-9983-20) / 10 mL in 1 VIAL, MULTI-DOSE 2022-07-22 Active

🧭 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ 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 FDA registers it as 0404-9983-20, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00404-9983-20, written without dashes as 00404998320. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00404-9983-20, the first segment (00404) is the labeler code FDA assigned to Henry Schein, Inc.; the middle segment (9983) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (20) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Henry Schein, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Henry Schein, 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🚨 Boxed Warning ~1 min read ▾

Boxed Warning WARNING: VENTRICULAR DYSRHYTHMIAS, CARDIAC ARREST, AND DEATH FROM HYPERKALEMIC RHABDOMYOLYSIS IN PEDIATRIC PATIENTS • Acute rhabdomyolysis with hyperkalemia followed by ventricular dysrhythmias, cardiac arrest, and death has occurred after the administration of succinylcholine to apparently healthy pediatric patients who were subsequently found to have undiagnosed skeletal muscle myopathy, most frequently Duchenne muscular dystrophy [see Warnings and Precautions ( 5.1)]. • When a healthy appearing pediatric patient develops cardiac arrest within minutes after administration of succinylcholine chloride injection, not felt to be due to inadequate ventilation, oxygenation or anesthetic overdose, immediate treatment for hyperkalemia should be instituted.

In the presence of signs of malignant hyperthermia, appropriate treatment should be instituted concurrently [see Warnings and Precautions ( 5.1)]. • Reserve the use of succinylcholine chloride injection in pediatric patients for emergency intubation or instances where immediate securing of the airway is necessary, e.g., laryngospasm, difficult airway, full stomach, or for intramuscular use when a suitable vein is inaccessible [see Warnings and Precautions ( 5.1)]. WARNING: VENTRICULAR DYSRHYTHMIAS, CARDIAC ARREST, AND DEATH FROM HYPERKALEMIC RHABDOMYOLYSIS IN PEDIATRIC PATIENTS SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. • ACUTE RHABDOMYOLYSIS WITH HYPERKALEMIA FOLLOWED BY VENTRICULAR DYSRHYTHMIAS, CARDIAC ARREST, AND DEATH HAS OCCURRED AFTER USE IN APPARENTLY HEALTHY PEDIATRIC PATIENTS WHO WERE SUBSEQUENTLY FOUND TO HAVE UNDIAGNOSED SKELETAL MUSCLE MYOPATHY.

( 5.1) • WHEN A HEALTHY-APPEARING PEDIATRIC PATIENT DEVELOPS CARDIAC ARREST SOON AFTER ADMINISTRATION OF SUCCINYLCHOLINE CHLORIDE INJECTION, NOT FELT TO BE DUE TO OTHER CAUSES, IMMEDIATE TREATMENT FOR HYPERKALEMIA SHOULD BE INSTITUTED. IN THE PRESENCE OF SIGNS OF MALIGNANT HYPERTHERMIA, APPROPRIATE TREATMENT SHOULD BE INSTITUTED CONCURRENTLY. ( 5.1) • RESERVE USE OF SUCCINYLCHOLINE CHLORIDE INJECTION IN PEDIATRIC PATIENTS FOR EMERGENCY INTUBATION OR INSTANCES WHERE IMMEDIATE SECURING OF THE AIRWAY IS NECESSARY, OR FOR INTRAMUSCULAR USE WHEN A SUITABLE VEIN IS INACCESSIBLE.

( 5.1)

🎯 Indications and Usage 80 words ▾

1 Indications and Usage Succinylcholine chloride injection is indicated in adults and pediatric patients: • as an adjunct to general anesthesia • to facilitate tracheal intubation • to provide skeletal muscle relaxation during surgery or mechanical ventilation. Succinylcholine chloride injection is a depolarizing neuromuscular blocker indicated in adults and pediatric patients: • as an adjunct to general anesthesia ( 1) • to facilitate tracheal intubation ( 1) • to provide skeletal muscle relaxation during surgery or mechanical ventilation.

( 1)

⏱️ Dosage and Administration ~3 min read ▾

2 Dosage and Administration

2.1Important Dosage and Administration Information • Succinylcholine chloride injection is for intravenous or intramuscular use only. • Succinylcholine chloride injection must be titrated to effect by or under supervision of experienced clinicians who are familiar with its actions and with appropriate neuromuscular monitoring techniques. • Succinylcholine chloride injection should be administered only by those skilled in the management of artificial respiration and only when facilities are instantly available for tracheal intubation and for providing adequate ventilation of the patient, including the administration of oxygen under positive pressure and the elimination of CO2.

The clinician must be prepared to assist or control respiration. • The dosage of succinylcholine chloride injection should be individualized and should always be determined by the clinician after careful assessment of the patient. • To avoid distress to the patient, do not administer succinylcholine chloride injection before unconsciousness has been induced [see Warnings and Precautions ( 5.14)]. • The occurrence of bradyarrhythmias with administration of succinylcholine chloride injection may be reduced by pretreatment with anticholinergics (e.g., atropine) [see Warnings and Precautions ( 5.6)]. • Monitor neuromuscular function with a peripheral nerve stimulator when using succinylcholine chloride injection by infusion [see Dosage and Administration ( 2.2), Warnings and Precautions ( 5.8)]. • Visually inspect succinylcholine chloride injection for particulate matter and discoloration prior to administration, whenever solution and container permit.

Do not administer solutions that are not clear and colorless. • Succinylcholine chloride injection supplied in single-dose vials must be diluted before use. Succinylcholine chloride injection supplied in multiple-dose vials does not require dilution before use [see Dosage and Administration ( 2.5)]. Risk of Medication Errors Accidental administration of neuromuscular blocking agents may be fatal.

Store succinylcholine chloride 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)].

2.2Dosage Recommendations for Intravenous Use in Adults For Short Surgical Procedures The average dose required to produce neuromuscular blockade and to facilitate tracheal intubation is 0.6 mg/kg succinylcholine chloride injection given intravenously. The optimum intravenous dose of succinylcholine chloride injection will vary among patients and may be from 0.3 mg/kg to 1.1 mg/kg for adults. Following intravenous administration of doses in this range, neuromuscular blockade develops in about 1 minute; maximum blockade may persist for about 2 minutes, after which recovery takes place within 4 to 6 minutes.

A 5 to 10 mg intravenous test dose of succinylcholine chloride injection may be used to determine the sensitivity of the patient and the individual recovery time [see Warnings and Precautions ( 5.9)]. For Long Surgical Procedures Continuous Intravenous Infusion The dosage of succinylcholine chloride injection administered by continuous intravenous infusion depends upon the duration of the surgical procedure and the need for muscle relaxation. Diluted succinylcholine chloride injection solutions containing from 1 mg/mL to 2 mg/mL succinylcholine have commonly been used for continuous intravenous infusion [see Dosage and Administration ( 2.5)].

The more dilute solution (1 mg/mL) is probably preferable from the standpoint of ease of control of the rate of administration of succinylcholine chloride injection and, hence, of relaxation. This diluted succinylcholine chloride injection solution containing 1 mg/mL succinylcholine may be administered intravenously at a rate of 0.5 mg (0.5 mL) per minute to 10 mg (10 mL) per minute to obtain the required amount of relaxation. The amount required per minute will…

💊 Dosage Forms and Strengths 55 words ▾

3 Dosage Forms and Strenghts Succinylcholine Chloride Injection, USP is supplied as a clear, colorless solution as follows: • 200 mg/10 mL (20 mg/mL) in multiple-dose fliptop vials contains: 20 mg of succinylcholine anhydrous (equivalent to 21.994 mg of succinylcholine chloride dihydrate). Injection: • 200 mg/10 mL (20 mg/mL) in multiple-dose fliptop vials ( 3)

⛔ Contraindications 148 words ▾

4 Contraindications Succinylcholine chloride is contraindicated: • in patients with skeletal muscle myopathies [see Warnings and Precautions ( 5.1)] • in patients with known hypersensitivity to succinylcholine. Severe anaphylactic reactions to succinylcholine have been reported [see Warnings and Precautions ( 5.2)] • after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, which may result in severe hyperkalemia and cardiac arrest [see Warnings and Precautions ( 5.4)] • in patients with known or suspected genetic susceptibility to malignant hyperthermia [see Warnings and Precautions ( 5.5), Clinical Pharmacology ( 12.5)] • Skeletal muscle myopathies ( 4) • Known hypersensitivity to succinylcholine ( 4) • After the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury ( 4) • Known or suspected genetic susceptibility to malignant hyperthermia ( 4)

⚠️ Warnings and Cautions ~3 min read ▾

5 Warnings and Precautions

5.1Ventricular Dysrhythmias, Cardiac Arrest, and Death From Hyperkalemic Rhabdomyolysis in Pediatric Patients There have been reports of ventricular dysrhythmias, cardiac arrest, and death secondary to acute rhabdomyolysis with hyperkalemia in apparently healthy pediatric patients who received succinylcholine. Many of these pediatric patients were subsequently found to have a skeletal muscle myopathy such as Duchenne muscular dystrophy whose clinical signs were not obvious. The syndrome often presented as sudden cardiac arrest within minutes after the administration of succinylcholine.

These pediatric patients were usually, but not exclusively, males, and most frequently 8 years of age or younger. There have also been reports in adolescents. There may be no signs or symptoms to alert the practitioner to which patients are at risk.

A careful history and physical may identify developmental delays suggestive of a myopathy. A preoperative creatine kinase could identify some but not all patients at risk. When a healthy-appearing pediatric patient develops cardiac arrest within minutes after administration of succinylcholine chloride injection, not felt to be due to inadequate ventilation, oxygenation or anesthetic overdose, immediate treatment for hyperkalemia should be instituted.

Due to the abrupt onset of this syndrome, routine resuscitative measures are likely to be unsuccessful. Careful monitoring of the electrocardiogram may alert the practitioner to peaked T-waves (an early sign). Administration of intravenous calcium, bicarbonate, and glucose with insulin, with hyperventilation have resulted in successful resuscitation in some of the reported cases.

Extraordinary and prolonged resuscitative efforts have been effective in some cases. In addition, in the presence of signs of malignant hyperthermia, appropriate treatment should be initiated concurrently [see Warnings and Precautions ( 5.5)]. Because it is difficult to identify which patients are at risk, reserve the use of succinylcholine chloride injection in pediatric patients for emergency intubation or instances where immediate securing of the airway is necessary, e.g., laryngospasm, difficult airway, full stomach, or for intramuscular use when a suitable vein is inaccessible.

5.2Anaphylaxis Severe anaphylactic reactions to neuromuscular blocking agents, including succinylcholine, have been reported. These reactions have, in some cases, 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.

Allergic cross-reactivity between neuromuscular blocking agents, both depolarizing and non-depolarizing, has been reported in this class of drugs. Therefore, assess patients for previous anaphylactic reactions to other neuromuscular blocking agents before administering succinylcholine chloride injection.

5.3Risk of Death due to Medication Errors Administration of succinylcholine chloride injection results in paralysis, which may lead to respiratory arrest and death; this progression 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 the product, ensure that the intended dose is clearly labeled and communicated.

5.4Hyperkalemia Succinylcholine chloride may induce serious cardiac arrhythmias or cardiac arrest due to hyperkalemia in patients with electrolyte abnormalities and those who may have digitalis toxicity. Succinylcholine chloride is contraindicated after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury [see Contraindications ( 4)]. The risk of hyperkalemia in these patients increases over time and usu…

🤒 Adverse Reactions ~1 min read ▾

6 Adverse Reactions The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: • Ventricular Dysrhythmias, Cardiac Arrest, and Death from Hyperkalemic Rhabdomyolysis in Pediatric Patients [see Warnings and Precautions ( 5.1)] • Anaphylaxis [see Warnings and Precautions ( 5.2)] • Hyperkalemia [see Warnings and Precautions ( 5.4)] • Malignant Hyperthermia [see Warnings and Precautions ( 5.5)] • Bradycardia [see Warnings and Precautions ( 5.6)] • Increase in Intraocular Pressure [see Warnings and Precautions ( 5.7)] • Prolonged Neuromuscular Block due to Phase II Block and Tachyphylaxis [see Warnings and Precautions ( 5.8)] The following adverse reactions associated with the use of succinylcholine were identified in clinical studies or postmarketing reports.

Because some of these reactions were 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: Cardiovascular disorders: Cardiac arrest, arrhythmias, bradycardia, tachycardia, hypertension, hypotension Electrolyte disorders : Hyperkalemia Eye disorders: Increased intraocular pressure Gastrointestinal disorders: Excessive salivation Immune system disorders: Hypersensitivity reactions including anaphylaxis (in some cases life-threatening and fatal) Musculoskeletal disorders: Malignant hyperthermia, rhabdomyolysis with possible myoglobinuric acute renal failure, muscle fasciculation, jaw rigidity, postoperative muscle pain Respiratory disorders: Prolonged respiratory depression or apnea Skin disorders: Rash Adverse reactions reported with succinylcholine are cardiac arrest, malignant hyperthermia, arrhythmias, bradycardia, tachycardia, hypertension, hypotension, hyperkalemia, prolonged respiratory depression or apnea.

( 6) To report SUSPECTED ADVERSE REACTIONS, contact Aspiro Pharma Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions 162 words ▾

7 Drug Interactions

7.1Drugs that May Affect the Neuromuscular Blocking Action of Succinylcholine Chloride injection Drugs that may enhance the neuromuscular blocking action of succinylcholine include: promazine, oxytocin, aprotinin, certain non-penicillin antibiotics, quinidine, β-adrenergic blockers, procainamide, lidocaine, trimethaphan, lithium carbonate, magnesium salts, quinine, chloroquine, isoflurane, desflurane, metoclopramide, and terbutaline. The neuromuscular blocking effect of succinylcholine may be enhanced by drugs that reduce plasma cholinesterase activity (e.g., chronically administered oral contraceptives, glucocorticoids, or certain monoamine oxidase inhibitors) or by drugs that irreversibly inhibit plasma cholinesterase [see Warnings and Precautions ( 5.9)].

If other neuromuscular blocking agents are to be used during the same procedure, consider the possibility of a synergistic or antagonistic effect. Drugs that May Enhance the Neuromuscular Blocking Action of Succinylcholine: promazine, oxytocin, aprotinin, certain non-penicillin antibiotics, quinidine, β-adrenergic blockers, procainamide, lidocaine, trimethaphan, lithium carbonate, magnesium salts, quinine, chloroquine, isoflurane, desflurane, metoclopramide, terbutaline, and drugs that reduce plasma cholinesterase activity.

( 7.1) See 17 for PATIENT COUNSELING INFORMATION. Revised: 01/2023

👥 Use in Specific Populations ~3 min read ▾

8 Use In Specific Populations

8.1Pregnancy Risk Summary Available data from published literature from case reports and case series over decades of use with succinylcholine during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Succinylcholine is used commonly during delivery by caesarean section to provide muscle relaxation. If succinylcholine is used during labor and delivery, there is a risk for prolonged apnea in some pregnant women (see Clinical Considerations).

Animal reproduction studies have not been conducted with succinylcholine chloride. The estimated 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 Maternal Adverse Reactions Plasma cholinesterase levels are decreased by approximately 24% during pregnancy and for several days postpartum which can prolong the effect of succinylcholine. Therefore, some pregnant patients may experience prolonged apnea.

Fetal/Neonatal Adverse Reactions Apnea and flaccidity may occur in the newborn after repeated high doses to, or in the presence of atypical plasma cholinesterase in, the mother. Labor or Delivery Succinylcholine is commonly used to provide muscle relaxation during delivery by caesarean section. Succinylcholine is known to cross the placental barrier in an amount that is dependent on the concentration gradient between the maternal and fetal circulation.

8.2Lactation Risk Summary There are no data on the presence of succinylcholine or its metabolite in either human or animal 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 succinylcholine chloride and any potential adverse effects on the breastfed infant from succinylcholine chloride or from the underlying maternal condition.

8.4Pediatric Use Safety and effectiveness of succinylcholine chloride have been established in pediatric patient age groups, neonate to adolescent. Because of a risk of ventricular dysrhythmias, cardiac arrest, and death from hyperkalemic rhabdomyolysis in pediatric patients, reserve the use of succinylcholine chloride in pediatric patients for emergency intubation or instances where immediate securing of the airway is necessary, e.g., laryngospasm, difficult airway, full stomach, or for intramuscular use when a suitable vein is inaccessible [see Warnings and Precautions ( 5.1)].

Intravenous bolus administration of succinylcholine chloride in pediatric patients (including infants) may result in profound bradycardia or, rarely, asystole. The incidence and severity of bradycardia is higher in pediatric patients than adults [see Warnings and Precautions ( 5.6)]. The effective dose of succinylcholine chloride in pediatric patients may be higher than that predicted by body weight dosing alone [see Dosage and Administration ( 2.3)].

8.5Geriatric Use Clinical studies of s uccinylcholine chloride did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, 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.

🆘 Overdosage 91 words ▾

10 Overdosage Overdosage with succinylcholine chloride may result in neuromuscular block beyond the time needed for surgery and anesthesia. This may be manifested by skeletal muscle weakness, decreased respiratory reserve, low tidal volume, or apnea. The primary treatment is maintenance of a patent airway and respiratory support until recovery of normal respiration is assured.

Depending on the dose and duration of succinylcholine chloride administration, the characteristic depolarizing neuromuscular block (Phase I) may change to a block with characteristics superficially resembling a non-depolarizing block (Phase II) [see Warnings and Precautions ( 5.8)].

🧬 Clinical Pharmacology ~3 min read ▾

12 Clinical Pharmacology

12.1Mechanism of Action Succinylcholine is a depolarizing neuromuscular blocker. As does acetylcholine, it combines with the cholinergic receptors of the motor end plate to produce depolarization. This depolarization may be observed as fasciculations.

Subsequent neuromuscular transmission is inhibited so long as adequate concentration of succinylcholine remains at the receptor site. Onset of flaccid paralysis is rapid (less than one minute after intravenous administration), and with single administration lasts approximately 4 to 6 minutes. The paralysis following administration of succinylcholine is progressive, with differing sensitivities of different muscles.

This initially involves consecutively the levator muscles of the face, muscles of the glottis and finally the intercostals and the diaphragm and all other skeletal muscles.

12.2Pharmacodynamics Depending on the dose and duration of succinylcholine administration, the characteristic depolarizing neuromuscular block (Phase I block) may change to a block with characteristics superficially resembling a non-depolarizing block (Phase II block). This may be associated with prolonged respiratory muscle paralysis or weakness in patients who manifest the transition to Phase II block. Tachyphylaxis occurs with repeated administration [see Warnings and Precautions ( 5.8)].

The transition from Phase I to Phase II block has been reported in 7 of 7 patients studied under halothane anesthesia after an accumulated dose of 2 to 4 mg/kg succinylcholine (administered in repeated, divided doses). The onset of Phase II block coincided with the onset of tachyphylaxis and prolongation of spontaneous recovery. In another study, using balanced anesthesia (N 2 O/O 2 /narcotic-thiopental) and succinylcholine infusion, the transition was less abrupt, with great individual variability in the dose of succinylcholine required to produce Phase II block.

Of 32 patients studied, 24 developed Phase II block. Tachyphylaxis was not associated with the transition to Phase II block, and 50% of the patients who developed Phase II block experienced prolonged recovery [see Warnings and Precautions ( 5.8)]. Succinylcholine has no direct effect on the myocardium.

Succinylcholine stimulates both autonomic ganglia and muscarinic receptors which may cause changes in cardiac rhythm, including cardiac arrest. Changes in rhythm, including cardiac arrest, may also result from vagal stimulation, which may occur during surgical procedures, or from hyperkalemia, particularly in pediatric patients [see Warnings and Precautions ( 5.1, 5.4, 5.6), Use in Specific Populations ( 8.4)]. These effects are enhanced by halogenated anesthetics.

Succinylcholine causes an increase in intraocular pressure immediately after its injection and during the fasciculation phase, and increases which may persist after onset of complete paralysis [see Warnings and Precautions ( 5.7)]. Succinylcholine may cause increases in intracranial pressure immediately after its injection and during the fasciculation phase [see Warnings and Precautions ( 5.11)]. As with other neuromuscular blocking agents, the potential for releasing histamine is present following succinylcholine administration.

Signs and symptoms of histamine-mediated release such as flushing, hypotension and bronchoconstriction are, however, uncommon with normal clinical usage. Succinylcholine has no effect on consciousness, pain threshold or cerebration [see Warnings and Precautions ( 5.14)]. Succinylcholine has no direct action on the uterus or other smooth muscle structures.

12.3Pharmacokinetics Elimination Succinylcholine levels were reported to be below the detection limit of 2 mcg/mL after 2.5 minutes of an intravenous bolus dose of 1 or 2 mg/kg in 14 anesthetized patients. Metabolism Succinylcholine is rapidly hydrolyzed by plasma cholinesterase to succinylmonocholine (which possesses clinically insignificant depolarizing muscle relaxant properties) and th…

📦 How Supplied / Storage and Handling 181 words ▾

16 How Supplied/Storage And Handling Succinylcholine Chloride Injection, USP is supplied as a clear, colorless solution in the following concentration and package: 200 mg/10 mL (20 mg/mL) 10 mL Multiple-dose Fliptop Vial: NDC 31722-981-10 25 Vials in a Carton: NDC 31722-981-31 Refrigeration of undiluted Succinylcholine Chloride Injection, USP will assure full potency until expiration date. Store in refrigerator 2° to 8°C (36° to 46°F). The multiple-dose vials are stable for up to 14 days at room temperature without significant loss of potency.

For more information, call 1-866-495-1995. Product repackaged by: Henry Schein, Inc., Bastian, VA 24314 From Original Manufacturer/Distributor's NDC and Unit of Sale To Henry Schein Repackaged Product NDC and Unit of Sale Total Strength/Total Volume (Concentration) per unit NDC 31722-981-31 25 10 mL Multiple-dose Fliptop Vials in a Carton NDC 0404-9983-20 1 10 mL Multiple-dose fliptop vial in a bag (Vial bears NDC 31722-981-10) 200 mg 200 mg/10 mL (20 mg/mL) Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854 Manufactured by: Aspiro Pharma Limited Survey No.

321, Biotech Park, Phase-III Karkapatla Village, Markook (Mandal) Siddipet, Telangana-502281, India. Revised: 01/2023

📋 Description 200 words ▾

11 Description Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine Chloride Injection, USP contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated C 14H 30Cl 2N 2O 4.2H 2O and its molecular weight is 397.34.

The chemical name of succinylcholine chloride is 2,2'-[(1,4-dioxo-1,4-butanediyl)bis(oxy)]bis[N,N,N-trimethyl-ethanaminium],dichloride. Succinylcholine chloride is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white or almost white, odourless, crystalline powder, freely soluble in water.

It has the following structural formula: Succinylcholine chloride injection USP, 200 mg/10 mL (20 mg/mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of succinylcholine chloride injection USP, 200 mg/10 mL (20 mg/mL) multiple-dose fliptop vials contains: 20 mg of succinylcholine chloride anhydrous (equivalent to 21.994 mg of succinylcholine chloride dihydrate), 1.8 mg of methylparaben and 0.2 mg of propylparaben as preservatives, 4.8 mg of sodium chloride as iso-osmotic agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection.

The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.). Formula1.jpg

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