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Bupivacaine Hydrochloride 7.5 mg/mL Injection, Solution

by ONESOURCE SPECIALTY PHARMA LIMITED · 1 VIAL in 1 CARTON (83270-167-01) / 30 mL in 1 VIAL

NDC 83270-0167-01

🏷️ FDA NDC (as labeled) 83270-167-01 billing pads the product 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 Dr. Brian Staiger, PharmD

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

⚠️

Other active recalls for Bupivacaine Hydrochloride (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 · Apr 2, 2026 — Lack of Assurance of Sterility (Huons Co., Ltd.) · FDA recall D-0530-2026

Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 83270-167-01

Product NDC 83270-167

11-digit billing NDC 83270016701

RxCUI 1724786, 1724787, 1724880, 1724884, 1725078, 1725082

UNII 7TQO7W3VT8

UPC 0383270165014, 0383270167018, 0383270164017, 0383270162013 +2 more

Application # ANDA091487

SPL Set ID 5c10e3a1-7806-40c7-afd2-4c420e141823

Established class (EPC) Amide Local Anesthetic

Physiologic effect Local Anesthesia

Chemical class Amides

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2026-01-29

Route EPIDURAL, RETROBULBAR

Dosage form INJECTION, SOLUTION

Substance BUPIVACAINE HYDROCHLORIDE

TE code (Orange Book) AP · RLD · RS

Why two NDCs? The FDA registers this code as 83270-167-01 — 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 → 83270-0167-01. 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 Amide Local Anesthetic class.

Pharmacologic class Amide Local Anesthetic

Drug family (ATC) Amides

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

LabelerONESOURCE SPECIALTY PHARMA LIMITED

Application holderONESOURCE SPECIALTY PTE LTD

FDA applicationANDA091487 (ANDA)

Labeler code83270

First marketedJan 2026

Product typeHuman Prescription Drug

Portfolio53 products on file

🔎 All NDCs from ONESOURCE SPECIALTY PHARMA LIMITED

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

📖 What it is MedlinePlus · NLM

Bupivacaine liposomal injection is used to manage pain after surgery. Bupivacaine is in a class of medications called local anesthetics. It works by blocking nerves from sending pain signals.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

Bupivacaine is a local anesthetic — it numbs a specific area of your body so you don't feel pain during a procedure. Your doctor or anesthesiologist injects it near the nerves that...
What exactly is bupivacaine and why is my doctor using it?
The most common ones are nausea, vomiting, constipation, dizziness, and headache. You might also notice your heart beating a little faster or your blood pressure dropping temporari...
What side effects should I expect after getting bupivacaine?

📖 Read our full Bupivacaine guide →

Patient education

📘 MedlinePlus patient leaflet ↗

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.
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.

3 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 system	Per mL	Per 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Bupivacaine Hydrochloride 7.5 mg/mL 00143-9335-10	Hikma	10 vials	—	AP	FDA listed	—
Bupivacaine Hydrochloride 7.5 mg/mL 00409-1165-01	Hospira,	25 vials	—	AP	FDA listed	—
Marcaine 7.5 mg/mL 00409-1582-10	Hospira,	10 vials	—	AP	FDA listed	—
Marcaine 225 mg/30mL 00409-2253-25	Hospira,	25 vials	—	AP	FDA listed	—
Bupivacaine Hydrochloride 7.5 mg/mL 31722-0277-31	Camber	10 vials	—	AP	FDA listed	—
Bupivacaine Hydrochloride 7.5 mg/mL 55150-0172-30	Eugia	25 vials	—	AP	FDA listed	—
Sensorcaine Mpf 7.5 mg/mL 63323-0472-17	Fresenius	25 vials	—	AP	Discontinued	—
Bupivacine HCl 7.5 mg/mL 70594-0121-01	Xellia	30 ml	—	AP	FDA listed	—
Bupivacaine Hydrochloride 7.5 mg/mL 72603-0800-25	NorthStar	25 vials	—	AP	FDA listed	—
Bupivacaine Hydrochloride 7.5 mg/mLthis 83270-0167-01	ONESOURCE	1 vial	—	AP	FDA listed	—
Bupivacaine Hydrochloride 7.5 mg/mL 83854-0005-10	Anthea	10 vials	—	AP	FDA listed	—
Bupivacaine Hydrochloride 7.5 mg/mL 83270-0164-10	ONESOURCE	10 vials	—	AP	FDA listed	—
Bupivacaine Hydrochloride 7.5 mg/mL 00143-9332-10	Hikma	10 vials	—	AP	FDA listed	—
Bupivacaine Hydrochloride 7.5 mg/mL 55150-0171-10	Eugia	25 vials	—	AP	FDA listed	—
Bupivacaine Hydrochloride 7.5 mg/mL 72603-0700-10	NorthStar	10 vials	—	AP	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2026

On the market since

Jan 2026

📍

2026

Currently FDA-listed

listed with the FDA

🔓

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 NDC	Description	Marketing start	Status
83270-0167-01 You're viewing this	1 VIAL in 1 CARTON (83270-167-01) / 30 mL in 1 VIAL	2026-01-29	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	✓ Available
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 83270-167-01, 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: 83270-0167-01, written without dashes as 83270016701. 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 83270-0167-01, the first segment (83270) is the labeler code FDA assigned to ONESOURCE SPECIALTY PHARMA LIMITED; the middle segment (0167) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 ONESOURCE SPECIALTY PHARMA LIMITED. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

ONESOURCE SPECIALTY PHARMA LIMITED 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 ▾

WARNING: RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE INJECTION IN OBSTETRICAL ANESTHESIA WARNING: RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE INJECTION IN OBSTETRICAL ANESTHESIA There have been reports of cardiac arrest with difficult resuscitation or death during use of bupivacaine hydrochloride injection for epidural anesthesia in obstetrical patients. In most cases, this has followed use of the 0.75% (7.5 mg/mL) concentration. Resuscitation has been difficult or impossible despite apparently adequate preparation and appropriate management.

Cardiac arrest has occurred after convulsions resulting from systemic toxicity, presumably following unintentional intravascular injection. The 0.75% (7.5 mg/mL) concentration of bupivacaine hydrochloride injection is not recommended for obstetrical anesthesia and should be reserved for surgical procedures where a high degree of muscle relaxation and prolonged effect are necessary [ see Warnings and Precautions (5.1) ]. WARNING: RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE INJECTION IN OBSTETRICAL ANESTHESIA See Full prescribing information for complete boxed warning.

There have been reports of cardiac arrest with difficult resuscitation or death during use of bupivacaine hydrochloride injection for epidural anesthesia in obstetrical patients. In most cases, this has followed use of the 0.75% (7.5 mg/mL) concentration. Resuscitation has been difficult or impossible despite apparently adequate preparation and appropriate management.

🎯 Indications and Usage 215 words ▾

1 INDICATIONS AND USAGE Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of bupivacaine hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [ see Dosage and Administration (2.2) ]. Limitations of Use Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use [ see Dosage and Administration (2.2) , Contraindications (4) , Warnings and Precautions ( 5.1 , 5.4 , 5.5 , 5.7 , 5.9 ) ].

Bupivacaine hydrochloride injection contains bupivacaine, an amide local anesthetic. Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. For each type of block indicated to produce local or regional anesthesia or analgesia, specific concentrations and presentations are recommended.

( 1 , 2.2 ) Limitations of Use Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use. ( 1 , 2.2 , 4 , 5.1 , 5.4 , 5.5 , 5.7 , 5.9 )

⏱️ Dosage and Administration 68 words ▾

2 DOSAGE AND ADMINISTRATION • Not for intrathecal use. (2.1) • Avoid use of solutions containing antimicrobial preservatives (i.e., multiple-dose vials) for epidural or caudal anesthesia. (2.1, 5.4) • See full prescribing information for: -Recommended concentrations and dosages of bupivacaine hydrochloride injection according to type of block.

(2.2) -Additional dosage and administration information pertaining to use in epidural anesthesia and use in ophthalmic surgery. (2.3, 2.4, 2.5, 2.6)

💊 Dosage Forms and Strengths 94 words ▾

3 DOSAGE FORMS AND STRENGTHS Bupivacaine hydrochloride injection is a clear, colorless solution available as: • 0.25% (25 mg/10 mL) (2.5 mg/mL) in single-dose vials. • 0.25% (75 mg/30 mL) (2.5 mg/mL) in single-dose vials. • 0.5% (50 mg/10 mL) (5 mg/mL) in single-dose vials. • 0.5% (150 mg/30 mL) (5 mg/mL) in single-dose vials. • 0.75% (75 mg/10 mL) (7.5 mg/mL) in single-dose vials. • 0.75% (225 mg/30 mL) (7.5 mg/mL) in single-dose vials. Bupivacaine hydrochloride injection is available in multiple concentrations. See full prescribing information for detailed description of each formulation.

(3)

⛔ Contraindications 111 words ▾

4 CONTRAINDICATIONS Bupivacaine hydrochloride injection is contraindicated in: • obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death. • intravenous regional anesthesia (Bier Block) [ see Warnings and Precautions (5.7) ]. • patients with a known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of bupivacaine hydrochloride injection. • Obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death.

(4) • Intravenous regional anesthesia (Bier Block). (4) • Known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of bupivacaine hydrochloride injection. (4)

⚠️ Warnings and Cautions 167 words ▾

5 WARNINGS AND PRECAUTIONS Dose-Related Toxicity : Monitor cardiovascular andrespiratory vital signs and patient’s state ofconsciousness after injection of bupivacaine hydrochloride injection. (5.2) Methemoglobinemia : Cases of methemoglobinemia have been reported in association with local anesthetic use. See full prescribing information for more detail on managing these risks.

(5.3) Chondrolysis with Intra-Articular Infusion : Intra-articular infusions of local anesthetics including bupivacaine hydrochloride injection following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions. (5.5) Risk of Cardiac Arrest with Intravenous Regional Anesthesia Use (Bier Block) : There have been reports of cardiac arrest and death during the use of bupivacaine for intravenous regional anesthesia (Bier Block).

(5.7) Risk of Systemic Toxicities with Unintended Intravascular or Intrathecal Injection : Unintended intravascular or intrathecal injection may be associated with systemic toxicities, including CNS or cardiorespiratory depression and coma, progressing ultimately to respiratory arrest. Aspirate for blood or cerebrospinal fluid (where applicable) prior to each dose. (5.9)

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions have been reported and described in the Warnings and Precautions section of the labeling: • Cardiac Arrest in Obstetrical Anesthesia [see Warnings and Precautions (5.1)] • Dose-Related Toxicity [see Warnings and Precautions (5.2)] • Methemoglobinemia [see Warnings and Precautions (5.3)] • Chondrolysis with Intra-Articular Infusion [see Warnings and Precautions (5.5)] • Cardiac Arrest with Intravenous Regional Anesthesia Use [see Contraindications (4), Warnings and Precautions (5.7)] • Systemic Toxicities with Unintended Intravascular or Intrathecal Injection [see Warnings and Precautions (5.9)] • Respiratory Arrest Following Retrobulbar Block [see Warnings and Precautions (5.15)] The following adverse reactions from voluntary reports or clinical studies have been reported with bupivacaine.

Because many 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. Adverse reactions to bupivacaine hydrochloride injection are characteristic of those associated with other amide-type local anesthetics. A major cause of adverse reactions to this group of drugs is excessive plasma levels, which may be due to overdosage, unintentional intravascular injection, or slow metabolic degradation.

The most commonly encountered acute adverse reactions that demand immediate counter-measures were related to the CNS and the cardiovascular system. These adverse reactions were generally dose-related and due to high plasma levels which may have resulted from overdosage, rapid absorption from the injection site, diminished tolerance, or from unintentional intravascular injection of the local anesthetic solution. In addition to systemic dose-related toxicity, unintentional intrathecal injection of drug during the intended performance of caudal or lumbar epidural block or nerve blocks near the vertebral column (especially in the head and neck region) has resulted in underventilation or apnea (“Total or High Spinal”).

Also, hypotension due to loss of sympathetic tone and respiratory paralysis or underventilation due to cephalad extension of the motor level of anesthesia have occurred. This has led to secondary cardiac arrest when untreated. Nervous System Disorders : Adverse reactions were characterized by excitation and/or depression of the central nervous system and included restlessness, anxiety, dizziness, tinnitus, blurred vision, tremors, convulsions, drowsiness, unconsciousness, respiratory arrest, nausea, vomiting, chills, pupillary constriction.

In the practice of caudal or lumbar epidural block, unintentional penetration of the subarachnoid space by the catheter or needle has occurred. Subsequent adverse effects may have depended partially on the amount of drug administered intrathecally and the physiological and physical effects of a dural puncture. A high spinal has been characterized by paralysis of the legs, loss of consciousness, respiratory paralysis, and bradycardia.

Neurologic effects following epidural or caudal anesthesia have included spinal block of varying magnitude (including high or total spinal block); hypotension secondary to spinal block; urinary retention; fecal and urinary incontinence; loss of perineal sensation and sexual function; persistent anesthesia, paresthesia, weakness, paralysis of the lower extremities and loss of sphincter control, all of which had slow, incomplete, or no recovery; headache; backache; septic meningitis; meningismus; slowing of labor; increased incidence of forceps delivery; and cranial nerve palsies due to traction on nerves from loss of cerebrospinal fluid.

Neurologic effects following other procedures or routes of administration have included persistent anesthesia, paresthesia, weakness, paralysis, all with slow, incomplete, or no recovery. Convulsions : Incidence varied with the proced…

🔄 Drug Interactions 59 words ▾

7 DRUG INTERACTIONS • Local Anesthetics : The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects when additional local anesthetics are administered. (7.1) • Drugs Associated with Methemoglobinemia : Patients are at increased risk of developing methemoglobinemia when concurrently exposed to nitrates, nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants, and other drugs.

(7.5)

👥 Use in Specific Populations 69 words ▾

8 USE IN SPECIFIC POPULATIONS • Pediatric Use : Administration of bupivacaine hydrochloride injection in pediatric patients younger than 12 years is not recommended. (8.4) • Geriatric Use : Patients 65 years and over, particularly those with hypertension, may be at increased risk for developing hypotension while undergoing anesthesia with bupivacaine hydrochloride injection. (8.5) • Moderate to Severe Hepatic Impairment : Consider increased monitoring for bupivacaine systemic toxicity.

(8.6)

🆘 Overdosage ~1 min read ▾

10 OVERDOSAGE Clinical Presentation Acute emergencies from use of bupivacaine hydrochloride injection are generally related to high plasma levels encountered during therapeutic use or to unintended intrathecal injection [ see Warnings and Precautions (5.2, 5.9), Adverse Reactions (6) ]. If not treated immediately, convulsions with simultaneous hypoxia, hypercarbia, and acidosis plus myocardial depression from the direct effects of bupivacaine may result in cardiac arrhythmias, bradycardia, asystole, ventricular fibrillation, or cardiac arrest.

Respiratory abnormalities, including apnea, may occur. Hypoventilation or apnea due to unintentional intrathecal injection of bupivacaine hydrochloride injection may produce these same signs and also lead to cardiac arrest if ventilatory support is not instituted. If cardiac arrest should occur, successful outcome may require prolonged resuscitative efforts.

Management The first step in the management of systemic toxic reactions, as well as hypoventilation or apnea due to unintentional intrathecal injection of bupivacaine hydrochloride injection, consists of immediate attention to the establishment and maintenance of a patent airway and effective assisted or controlled ventilation with 100% oxygen with a delivery system capable of permitting immediate positive airway pressure by mask. Endotracheal intubation, using drugs and techniques familiar to the clinician, may be indicated after initial administration of oxygen by mask if difficulty is encountered in the maintenance of a patent airway, or if prolonged ventilatory support (assisted or controlled) is indicated.

If necessary, use drugs to manage the convulsions. A bolus intravenous dose of a benzodiazepine will counteract CNS stimulation related to bupivacaine hydrochloride injection. Immediately after the institution of ventilatory measures, evaluate the adequacy of the circulation.

Supportive treatment of circulatory depression may require Advance Cardiac Life Support measures.

🧬 Clinical Pharmacology 90 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Bupivacaine blocks the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential. In general, the progression of anesthesia is related to the diameter, myelination, and conduction velocity of affected nerve fibers. Clinically, the order of loss of nerve function is as follows: (1) pain, (2) temperature, (3) touch, (4) proprioception, and (5) skeletal muscle tone.

📦 How Supplied / Storage and Handling 179 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C to 30 °C (59 ° F to 86 °F). [See USP Controlled Room Temperature.] Protect from light. This product is clear and colorless. Do not use the solution if it is discolored or if it contains a precipitate.

Unit of Sale Concentration Each 0.25% Contains 2.5 mg bupivacaine hydrochloride per mL. NDC 83270-162-10 Carton of 10 25 mg/10 mL (2.5 mg/mL) NDC 83270-162-01 single-dose vial NDC 83270-165-01 Carton of 1 75 mg/30 mL (2.5 mg/mL) NDC 83270-165-01 single-dose vial 0.5% Contains 5 mg bupivacaine hydrochloride per mL. NDC 83270-163-10 Carton of 10 50 mg/10 mL (5 mg/mL) NDC 83270-163-01 single-dose vial NDC 83270-166-01 Carton of 1 150 mg/30 mL (5 mg/mL) NDC 83270-166-01 single-dose vial 0.75% Contains 7.5 mg bupivacaine hydrochloride per mL.

NDC 83270-164-10 Carton of 10 75 mg/10 mL (7.5 mg/mL) NDC 83270-164-01 single-dose vial NDC 83270-167-01 Carton of 1 225 mg/30 mL (7.5 mg/mL) NDC 83270-167-01 single-dose vial For single-dose vials: Discard unused portion.

📋 Description 153 words ▾

11 DESCRIPTION Bupivacaine hydrochloride injection contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for bupivacaine hydrochloride injection is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use.[ see Warnings and Precautions (5.4) ]. Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate.

It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula: Bupivacaine hydrochloride injection is a clear and colorless sterile isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection.

For the Multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. Structure

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

apnea: A pause or temporary stop in breathing.

bolus: A single dose given all at once, often as a quick push into a vein.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

cardiac arrest: A sudden stop of the heart's pumping that cuts off blood flow to the body, which is a medical emergency.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

depression: A lasting low mood with loss of interest that affects everyday life.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

hypoxia: A condition in which the body's tissues do not get enough oxygen.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

infusion: Slowly delivering fluid or medicine into a vein over a period of time, usually through a drip.

intrathecal: Injected into the fluid that surrounds the spinal cord.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

methemoglobinemia: A condition where the blood carries less oxygen than normal because of a change in its oxygen-carrying protein.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

paresthesia: A tingling, prickling, or "pins and needles" feeling in the skin, often in the hands or feet.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

restlessness: An inability to stay calm or still, with a constant feeling of needing to move.

single-dose vial: A small container holding one dose of medicine, meant to be used once and then thrown away.

tinnitus: Ringing, buzzing, or other noise in the ears that is not coming from an outside sound.

tolerance: When the body gets used to a medicine over time, so a larger dose is needed to get the same effect.

Unapproved use: Giving a medicine for a purpose the FDA has not reviewed or approved.

urinary retention: Being unable to empty the bladder fully or at all.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

ventricular fibrillation: A life-threatening, chaotic rhythm in the heart's lower chambers that stops the heart from pumping blood effectively.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

← 83270-0166-01 · ONESOURCE 83270-0168-01 · ONESOURCE →

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.

Bupivacaine Hydrochloride 7.5 mg/mL Injection, Solution

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