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Medicine

Ropivacaine 40 mg/20 mL injection

Ropivacaine · Epidural, infiltration
Available on requestPrescription onlyUS FDAGeneric name

Ropivacaine 40 mg/20 mL injection is a generic prescription medicine for epidural, infiltration use, made by 3 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Solutions should be stored at 20ºC to 25°C (68 ºF to 77 °F), excursions…

Key facts

Active ingredient (INN)
Ropivacaine
Brand
Sold under the generic name
Strength
40 mg/20 mL
Dosage form
Injection
Route
Epidural, infiltration
Packs
10 vials of 20 mL, 25 vials of 20 mL and 2 more
Manufacturers
Anthea PharmaIndiaGlenmark PharmaceuticalsIndiaHikma Pharmaceuticals
Origin register
US FDA, United States
Storage
Solutions should be stored at 20ºC to 25°C (68 ºF to 77 °F), excursions permitted to 15°C to 30°C (59°F to 86°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
21 March 2025
Identifiers
RxCUI 1734084, 1734207, 1734475 +3DailyMed set ID f2b54355-a596-4f97-aeaa-d93e3984c42d, 35743510-728d-407b-b501-cf019665cd35, 043b28cc-ce5c-4351-a646-704c381decb9NDC 83854-013, 0143-9263, 68462-793Application ANDA219883, ANDA214074

Record updated 12 November 2026

Documents available

Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.

No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.

Packs

Packs from every labeler of this generic presentation.

PackCodeLabelerMarketed since
10 vial in 1 carton / 20 mL in 1 vial83854-013-10Anthea PharmaIndia21 March 2025
25 vial in 1 carton / 20 mL in 1 vial83854-013-25Anthea PharmaIndia21 March 2025
25 vial in 1 carton / 20 mL in 1 vial68462-793-55Glenmark PharmaceuticalsIndia7 August 2025
10 vial in 1 carton / 20 mL in 1 vial68462-793-74Glenmark PharmaceuticalsIndia7 August 2025
10 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose0143-9263-10Hikma Pharmaceuticals18 November 2025
10 vial in 1 carton / 20 mL in 1 vial65145-107-10—24 June 2025
25 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose55150-195-20—15 September 2016
10 vial in 1 carton / 20 mL in 1 vial43066-015-10—9 April 2020
25 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose71288-733-21—30 July 2024
10 vial in 1 carton / 20 mL in 1 vial70069-062-10—2 March 2022
25 vial in 1 carton / 20 mL in 1 vial70069-062-25—15 June 2018

Status by register

Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 24 September 1996Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Import route

Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.

Import guides are available for 25 countries. Pick one to see its route summary.

BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides

Alternatives

Other makers and brands of Ropivacaine 40 mg/20 mL injection.

Compare all 2

Other strengths and forms of Ropivacaine

Clinical summary

Ropivacaine is an amide local anesthetic indicated for the production of local or regional anesthesia for surgery and for acute pain management. It is available as injection for epidural, infiltration and perineural use. MedsAcross supplies Ropivacaine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Read about Ropivacaine

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Ropivacaine 40 mg/20 mL injection for your hospital or patient?

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