Prescription medicine
Bupivacaine Brand names: Marcaine, Sensorcaine, Exparel
Bupivacaine (Exparel) is a prescription medicine with an FDA approval on record since 1978. FDA's NDC Directory lists it from 26 generic labelers, and pharmacies paid $0.086 per mL (Bupivacaine 0.5% vial) in the October 7, 2026 NADAC survey.
- Generic listed
- In shortage
- Boxed warning
Check it at the source: the bupivacaine FDA label on DailyMed (effective April 14, 2026, Hospira, Inc.); the NDA 18053 record on Drugs@FDA; every bupivacaine label on DailyMed.
Highlights of the record
FDA label of April 14, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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. […]
Used for
From the label: indications and usageBupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures.
Forms and strengths
- 2.5 mg/ml
- 5 mg/ml
- 7.5 mg/ml
- 13.3 mg/ml
- 25 mg/10ml
- 50 mg/10ml
- 75 mg/30ml
- 150 mg/30ml
- 225 mg/30ml
- 250 mg/50ml
Injection (solution); injection (suspension) (liposomal); injection.
On the market
- Earliest approval on file
- April 17, 1978 Bupivacaine Hydrochloride, Hospira; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 30 first May 21, 1986; 21 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 27 of which 26 under generic applications, 5 under brand applications, repackagers included
- Last listed patent
- July 2, 2044 Exparel injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.086 per mL Bupivacaine 0.5% vial
- Shortage (FDA)
- 8 of 35 presentations limited or unavailable updated October 2, 2026
- Recalls by its makers (FDA)
- 17 since 2013 8 Class I among all firms' recalls; latest April 2, 2026; 11 more by firms not listed as its makers
- FAERS reports
- 16,179 through July 30, 2026
What is bupivacaine used for?
From the label: indications and usageBupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2) ]. […]
FDA pharmacologic class: Amide Local Anesthetic.
Source: FDA drug label (BUPIVACAINE HYDROCHLORIDE), Hospira, Inc., effective April 14, 2026 (SPL set bb44c7e1-d911-4788-908f-09b7b271969b), via openFDA; the full label on DailyMed
Is there a generic for bupivacaine (Exparel)?
The FDA approved the first generic bupivacaine on May 21, 1986. 30 generic applications are approved; 21 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists bupivacaine from 26 labelers under a generic (ANDA) application and from 5 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 21 patents for Exparel injection, the last expiring on July 2, 2044. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1978 earliest approval on file
- 1986 first generic approved
- 2044 last listed patent
- 2018 to now in shortage
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for bupivacaine (Exparel)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.086 per mL (Bupivacaine 0.5% vial), up 4% from $0.0831 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Bupivacaine 0.25% vial (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Bupivacaine 0.25% vial | Generic | $0.0479 per mL | n/a | +3% |
| Bupivacaine 0.5% vial | Generic | $0.086 per mL | n/a | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is bupivacaine in shortage?
The FDA Drug Shortage Database lists 8 of 35 bupivacaine presentations as limited or unavailable (updated October 2, 2026); the first entry was posted on February 20, 2018. 22 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Bupivacaine Hydrochloride PRESERVATIVE FREE, Injection, 2.5 mg/1 mL 5mg / 1mL (NDC 72266-263-10) | ONESOURCE SPECIALTY PTE LTD | Current | September 18, 2026 |
| Bupivacaine Hydrochloride, Injection, 2.5 mg/1 mL (NDC 31722-275-32) | Aspiro Pharma Limited | Current | July 17, 2026 |
| Bupivacaine Hydrochloride, Injection, 2.5 mg/1 mL (NDC 31722-275-34) | Aspiro Pharma Limited | Current | July 17, 2026 |
| Bupivacaine Hydrochloride, Injection, 2.5 mg/1 mL (NDC 55150-167-10) | Eugia US LLC | Current | October 2, 2026 |
| Bupivacaine Hydrochloride, Injection, 2.5 mg/1 mL (NDC 55150-168-30) | Eugia US LLC | Current | October 2, 2026 |
| Bupivacaine Hydrochloride, Injection, 2.5 mg/1 mL (NDC 55150-249-50) | Eugia US LLC | Current | October 2, 2026 |
| Bupivacaine Hydrochloride, Injection, 2.5 mg/1 mL (NDC 70069-752-01) | Somerset Therapeutics, LLC | Current | September 11, 2026 |
| Bupivacaine Hydrochloride, Injection, 2.5 mg/1 mL (NDC 70069-752-10) | Somerset Therapeutics, LLC | Current | September 11, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has bupivacaine been recalled?
The FDA's Enforcement Report lists 28 recalls naming bupivacaine since 2013: 8 Class I (the most serious), 20 Class II, 0 Class III; 3 still ongoing. 11 of them are by firms that FDA's NDC Directory does not list as a maker of bupivacaine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 2, 2026 | Class II | Huons Co., Ltd. | Lack of Assurance of Sterility |
| June 2, 2025 | Class II | Tailstorm Health INC not a listed maker | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. |
| June 30, 2022 | Class II | Nephron Sterile Compounding Center LLC not a listed maker | Lack of Assurance of Sterility |
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| May 3, 2021 | Class I | PFIZER, INC | Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials … |
| November 21, 2019 | Class II | Pacira Pharmaceuticals, Inc. | Sub Potent Drug: Out of Specification (OOS) |
| September 16, 2016 | Class II | Hospira Inc., A Pfizer Company | Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product … |
| August 4, 2016 | Class I | Hospira Inc., A Pfizer Company | Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the bupivacaine label say about other medicines?
The bupivacaine label names 26 other medicines in its interaction, contraindication or warning sections. The labels of 9 other medicines name bupivacaine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | drug interactions | Class: Other drugs; Examples: acetaminophen, metoclopramide, quinine, sulfasalazine |
| Benzocaine | drug interactions | Class: Local anesthetics; Examples: articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine |
| Chloroquine | drug interactions | Class: Antimalarials; Examples: chloroquine, primaquine |
| Cyclophosphamide | drug interactions | Class: Antineoplastic agents; Examples: cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase |
| Dapsone | drug interactions | Class: Antibiotics; Examples: dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides |
| Epinephrine | contraindications | CONTRAINDICATIONS Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is contraindicated in: |
| Flutamide | drug interactions | Class: Antineoplastic agents; Examples: cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase |
| Hydroxyurea | drug interactions | Class: Antineoplastic agents; Examples: cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase |
| Ifosfamide | drug interactions | Class: Antineoplastic agents; Examples: cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase |
| Lidocaine | drug interactions | Class: Local anesthetics; Examples: articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine |
| Mepivacaine | drug interactions | Class: Local anesthetics; Examples: articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine |
| Methylene blue | warnings and precautions | A more severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen. |
| Metoclopramide | drug interactions | Class: Other drugs; Examples: acetaminophen, metoclopramide, quinine, sulfasalazine |
| Nitric oxide | drug interactions | Class: Nitrates/Nitrites; Examples: nitric oxide, nitroglycerin, nitroprusside, nitrous oxide |
Every other medicine the bupivacaine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Nitrofurantoin | drug interactions | Class: Antibiotics; Examples: dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides |
| Nitroglycerin | drug interactions | Class: Nitrates/Nitrites; Examples: nitric oxide, nitroglycerin, nitroprusside, nitrous oxide |
| Nitrous oxide | drug interactions | Class: Nitrates/Nitrites; Examples: nitric oxide, nitroglycerin, nitroprusside, nitrous oxide |
| Phenobarbital | drug interactions | Class: Anticonvulsants; Examples: phenobarbital, phenytoin, sodium valproate |
| Phenytoin | drug interactions | Class: Anticonvulsants; Examples: phenobarbital, phenytoin, sodium valproate |
| Prilocaine | drug interactions | Class: Local anesthetics; Examples: articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine |
| Primaquine | drug interactions | Class: Antimalarials; Examples: chloroquine, primaquine |
| Quinine | drug interactions | Class: Other drugs; Examples: acetaminophen, metoclopramide, quinine, sulfasalazine |
| Rasburicase | drug interactions | Class: Antineoplastic agents; Examples: cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase |
| Ropivacaine | drug interactions | Class: Local anesthetics; Examples: articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine |
| Sulfasalazine | drug interactions | Class: Other drugs; Examples: acetaminophen, metoclopramide, quinine, sulfasalazine |
| Tetracaine | drug interactions | Class: Local anesthetics; Examples: articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine |
Source: FDA drug label (BUPIVACAINE HYDROCHLORIDE), Hospira, Inc., effective April 14, 2026 (SPL set bb44c7e1-d911-4788-908f-09b7b271969b), via openFDA; the full label on DailyMed
What do FAERS reports show for bupivacaine?
The FDA Adverse Event Reporting System holds 16,179 reports that list bupivacaine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 974 are coded as a death and 4,086 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other amide local anesthetics
- the pharmacologic class, with prices and generics
- Bupivacaine side effects
- the label's list beside FAERS reports
- Bupivacaine shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other