Medicine
Ropivacaine 400 mg/200 mL injection
Ropivacaine 400 mg/200 mL injection is a generic prescription medicine for epidural, infiltration, perineural use, made by 5 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
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 20 °C to 25 °C (68 °F to 77 °F).
Key facts
- Active ingredient (INN)
- Ropivacaine
- Brand
- Sold under the generic name
- Strength
- 400 mg/200 mL
- Dosage form
- Injection
- Route
- Epidural, infiltration, perineural
- Packs
- 12 pouches of 200 mL, 24 pouches of 200 mL, 24 bags of 200 mL and 3 more
- Manufacturers
- Amneal PharmaceuticalsFresenius KabiHikma PharmaceuticalsMylan InstitutionalSOLA Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Solutions should be stored at 20 °C to 25 °C (68 °F to 77 °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
- 17 March 2023
- Identifiers
- RxCUI 1734347, 1734355, 1734479 +1DailyMed set ID da4a7675-97bf-4d2a-9fdc-c1b4b2999126, 3d465e02-fd09-41b8-847f-bfe99cb4a712, da1ce22b-6a8e-40a2-afbb-011fa3ed3a8b +2NDC 65219-632, 0143-9196, 70121-1733 +2Application ANDA212808, ANDA211907, ANDA216605 +1
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.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 12 pouch in 1 carton / 1 bag in 1 pouch / 200 mL in 1 bag | 70121-1733-3 | Amneal Pharmaceuticals | 4 December 2023 |
| 24 pouch in 1 carton / 1 bag in 1 pouch / 200 mL in 1 bag | 70121-1733-9 | Amneal Pharmaceuticals | 17 March 2023 |
| 24 bag in 1 case / 200 mL in 1 bag | 65219-632-20 | Fresenius Kabi | 3 February 2025 |
| 12 bag in 1 case / 200 mL in 1 bag | 0143-9196-12 | Hikma Pharmaceuticals | 7 November 2025 |
| 10 pouch in 1 carton / 1 bag in 1 pouch / 200 mL in 1 bag | 67457-799-99 | Mylan Institutional | 18 March 2024 |
| 24 bag in 1 carton / 200 mL in 1 bag | 70512-798-24 | SOLA Pharmaceuticals | 1 March 2025 |
| 10 pouch in 1 case / 1 bag in 1 pouch / 200 mL in 1 bag | 65145-166-10 | — | 24 June 2025 |
| 1 bag in 1 pouch / 200 mL in 1 bag | 68083-263-01 | — | 18 August 2022 |
| 10 bag in 1 carton / 200 mL in 1 bag | 25021-671-67 | — | 1 January 2020 |
| 10 bag in 1 carton / 200 mL in 1 bag | 25021-671-87 | — | 15 December 2018 |
| 10 bag in 1 carton / 200 mL in 1 bag | 43066-154-10 | — | 1 January 2024 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 24 September 1996 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US 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 400 mg/200 mL injection.
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 RopivacaineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Naropin prescribing information (Fresenius Kabi) · U.S. National Library of Medicine, DailyMed
Need Ropivacaine 400 mg/200 mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.