Prescription medicine
Ropivacaine Brand names: Naropin
Ropivacaine (Naropin) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 18 generic labelers.
- Generic listed
- In shortage
Check it at the source: the ropivacaine FDA label on DailyMed (effective August 6, 2024, Fresenius Kabi USA, LLC); the NDA 20533 record on Drugs@FDA; every ropivacaine label on DailyMed.
Highlights of the record
FDA label of August 6, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageNAROPIN is indicated for the production of local or regional anesthesia for surgery and for acute pain management.
Forms and strengths
- 2 mg/ml
- 5 mg/ml
- 7.5 mg/ml
- 10 mg/ml
- 150 mg/30ml
Injection (solution); injection.
On the market
- Earliest approval on file
- September 24, 1996 Naropin, Fresenius Kabi Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 16 first July 17, 2014; 14 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 19 of which 18 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- November 28, 2026 Naropin injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- 15 of 49 presentations limited or unavailable updated October 6, 2026
- Recalls by its makers (FDA)
- 4 since 2017 1 Class I among all firms' recalls; latest July 16, 2026; 5 more by firms not listed as its makers
- FAERS reports
- 2,349 through July 30, 2026
What is ropivacaine used for?
From the label: indications and usageNAROPIN is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration NAROPIN is an amide local anesthetic indicated in adults for the production of local or regional anesthesia for surgery and for acute pain management. […]
Conditions named in the indications of ropivacaine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Amide Local Anesthetic.
Source: FDA drug label (Naropin), Fresenius Kabi USA, LLC, effective August 6, 2024 (SPL set 23d2d448-a744-4877-9f2d-7e57c198da89), via openFDA; the full label on DailyMed
Is there a generic for ropivacaine (Naropin)?
The FDA approved the first generic ropivacaine on July 17, 2014. 16 generic applications are approved; 14 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 ropivacaine from 18 labelers under a generic (ANDA) application and from 2 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 1 patent for Naropin injection, the last expiring on November 28, 2026. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1996 earliest approval on file
- 2014 first generic approved
- 2026 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)
Is ropivacaine in shortage?
The FDA Drug Shortage Database lists 15 of 49 ropivacaine presentations as limited or unavailable (updated October 6, 2026); the first entry was posted on March 23, 2018. 34 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Naropin, Injection, 10 mg/1 mL (NDC 63323-288-10) | Fresenius Kabi USA, LLC | Current | October 6, 2026 |
| Naropin, Injection, 10 mg/1 mL (NDC 63323-288-11) | Fresenius Kabi USA, LLC | Current | October 6, 2026 |
| Naropin, Injection, 10 mg/1 mL (NDC 63323-288-20) | Fresenius Kabi USA, LLC | Current | October 6, 2026 |
| Naropin, Injection, 10 mg/1 mL (NDC 63323-288-21) | Fresenius Kabi USA, LLC | Current | October 6, 2026 |
| Naropin, Injection, 2 mg/1 mL (NDC 63323-285-10) | Fresenius Kabi USA, LLC | Current | October 6, 2026 |
| Naropin, Injection, 2 mg/1 mL (NDC 63323-285-13) | Fresenius Kabi USA, LLC | Current | October 6, 2026 |
| Naropin, Injection, 2 mg/1 mL (NDC 63323-285-20) | Fresenius Kabi USA, LLC | Current | October 6, 2026 |
| Naropin, Injection, 2 mg/1 mL (NDC 63323-285-23) | Fresenius Kabi USA, LLC | Current | October 6, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has ropivacaine been recalled?
The FDA's Enforcement Report lists 9 recalls naming ropivacaine since 2017: 1 Class I (the most serious), 8 Class II, 0 Class III; 3 still ongoing. 5 of them are by firms that FDA's NDC Directory does not list as a maker of ropivacaine 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 |
|---|---|---|---|
| July 16, 2026 | Class II | Fresenius Kabi USA, LLC | Presence of Particulate Matter: Hair was found in products |
| April 17, 2025 | Class I | Amneal Pharmaceuticals, LLC | Presence of Particulate Matter |
| April 26, 2023 | Class II | Akorn, Inc. | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| June 30, 2022 | Class II | Nephron Sterile Compounding Center LLC not a listed maker | Lack of Assurance of Sterility |
| May 17, 2018 | Class II | Guardian Pharmacy Services not a listed maker | Lack of sterility assurance. |
| October 10, 2017 | Class II | Banner Pharmacy Services, LLC not a listed maker | Lack of Assurance of Sterility. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ropivacaine label say about other medicines?
The ropivacaine label names 31 other medicines in its interaction, contraindication or warning sections. The labels of 11 other medicines name ropivacaine. 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 |
| Amiodarone | drug interactions | Specific trials studying the interaction between ropivacaine and class III antiarrhythmic drugs (e.g., amiodarone) have not been performed, but caution is advised [see Warnings and Precautions ( 5.13 )]. |
| Benzocaine | drug interactions | Class: Local anesthetics; Examples: articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine |
| Bupivacaine | 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 | warnings and precautions | When clinical conditions permit, consideration should be given to employing local anesthetic solutions, which contain epinephrine for the test dose because circulatory changes compatible with epinephrine may also serve as a warning sign of unintended intravascular injection. |
| Flutamide | drug interactions | Class: Antineoplastic agents; Examples: cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase |
| Fluvoxamine | drug interactions | In vivo, the plasma clearance of ropivacaine was reduced by 70% during coadministration of fluvoxamine (25 mg bid for 2 days), a selective and potent CYP1A2 inhibitor. |
| Hydroxyurea | drug interactions | Class: Antineoplastic agents; Examples: cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase |
| Ifosfamide | drug interactions | Class: Antineoplastic agents; Examples: cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase |
| Imipramine | drug interactions | Possible interactions with drugs known to be metabolized by CYP1A2 via competitive inhibition such as theophylline and imipramine may also occur. |
| Ketoconazole | drug interactions | Coadministration of a selective and potent inhibitor of CYP3A4, ketoconazole (100 mg bid for 2 days with ropivacaine infusion administered 1 hour after ketoconazole) caused a 15% reduction in in vivo plasma clearance of ropivacaine. |
Every other medicine the ropivacaine label names
| Medicine named | Section | What the label says |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Theophylline | drug interactions | Possible interactions with drugs known to be metabolized by CYP1A2 via competitive inhibition such as theophylline and imipramine may also occur. |
Source: FDA drug label (Naropin), Fresenius Kabi USA, LLC, effective August 6, 2024 (SPL set 23d2d448-a744-4877-9f2d-7e57c198da89), via openFDA; the full label on DailyMed
What do FAERS reports show for ropivacaine?
The FDA Adverse Event Reporting System holds 2,349 reports that list ropivacaine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 118 are coded as a death and 642 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
- Ropivacaine side effects
- the label's list beside FAERS reports
- Ropivacaine shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other