Medicine
Rocuronium 50 mg/5 mL injection
Rocuronium 50 mg/5 mL injection is a generic prescription medicine for intravenous use, made by 25 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Rocuronium bromide injection is a sterile, nonpyrogenic, isotonic solution…
Key facts
- Active ingredient (INN)
- Rocuronium
- Brand
- Sold under the generic name
- Strength
- 50 mg/5 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 10 vials of 5 mL, 1 vial of 5 mL, 10 syringes of 5 mL and 42 more
- Manufacturers
- Lifestar PharmaIndiaCaplin SterilesIndiaEugiaIndiaGland PharmaIndiaPiramal Critical CareIndiaSteriscience SpecialtiesIndiaFresenius KabiMedical Purchasing SolutionsHospiraHealthFirst25 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Rocuronium bromide injection is a sterile, nonpyrogenic, isotonic solution, clear colorless to yellow or orange solution, free from visible particles and is supplied as follows: 50 mg/5 mL (10 mg/mL) NDC 71839-141-10 Multiple-dose vials of 5 mL in boxes of 10 100 mg/10 mL (10 mg/mL) NDC 71839-142-10 Multiple-dose vials of 10 mL in boxes of 10 Rocuronium bromide should be stored in a refrigerator…
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- M03AC09 Rocuronium
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 December 2008
- Identifiers
- RxCUI 1234995, 2720024, 2720026 +2DailyMed set ID 1543ea2b-54ab-4088-a72a-5d71854a2dce, 6045ed5a-5d2c-4f17-aaba-458fbf87e85c, cb28d869-6510-4402-9462-f6bb25fa0fa8 +37NDC 71839-141, 72162-2263, 0781-3220 +37Application ANDA216234, ANDA210437, ANDA079195 +15
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
A sample of 40 packs from 25 labelers. The register lists 45 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 10 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 65145-130-10 | Caplin SterilesIndia | 3 October 2024 |
| 10 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 55150-225-05 | EugiaIndia | 12 April 2017 |
| 10 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 68083-364-10 | Gland PharmaIndia | 18 May 2018 |
| 10 vial in 1 carton / 5 mL in 1 vial | 70756-669-10 | Lifestar PharmaIndia | 29 May 2025 |
| 1 vial in 1 carton / 5 mL in 1 vial | 70756-669-85 | Lifestar PharmaIndia | 29 May 2025 |
| 10 vial in 1 carton / 5 mL in 1 vial | 66794-228-41 | Piramal Critical CareIndia | 20 July 2020 |
| 10 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 82449-001-02 | Steriscience SpecialtiesIndia | 30 November 2024 |
| 10 vial in 1 tray / 5 mL in 1 vial | 63323-426-05 | Fresenius Kabi | 13 December 2009 |
| 10 vial in 1 tray / 5 mL in 1 vial | 63323-426-15 | Fresenius Kabi | 13 December 2009 |
| 10 vial in 1 tray / 5 mL in 1 vial | 65219-065-05 | Fresenius Kabi | 7 March 2022 |
| 10 vial in 1 tray / 5 mL in 1 vial | 65219-442-05 | Fresenius Kabi | 11 October 2023 |
| 10 vial in 1 tray / 5 mL in 1 vial | 65219-695-05 | Fresenius Kabi | 11 October 2023 |
| 10 syringe in 1 carton / 5 mL in 1 syringe | 76045-220-50 | Fresenius Kabi | 6 July 2026 |
| 10 syringe in 1 carton / 5 mL in 1 syringe | 76045-221-50 | Fresenius Kabi | 6 July 2026 |
| 10 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 0409-1403-10 | Hospira | 28 August 2023 |
| 10 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 0409-3189-10 | Hospira | 17 July 2023 |
| 10 vial, multi-dose in 1 box / 5 mL in 1 vial, multi-dose | 0409-9558-05 | Hospira | 1 December 2008 |
| 10 vial, multi-dose in 1 box / 5 mL in 1 vial, multi-dose | 0409-9558-49 | Hospira | 15 December 2008 |
| 10 vial in 1 carton / 5 mL in 1 vial | 43066-007-10 | Baxter Healthcare | 15 July 2019 |
| 5 carton in 1 carton / 1 syringe, plastic in 1 carton / 5 mL in 1 syringe, plastic | 43066-507-05 | Baxter Healthcare | 18 September 2026 |
| 10 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 71288-700-06 | Meitheal Pharmaceuticals | 8 May 2023 |
| 10 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 71288-700-92 | Meitheal Pharmaceuticals | 8 May 2023 |
| 30 box in 1 case / 10 syringe in 1 box / 5 mL in 1 syringe | 0264-5711-10 | B. Braun Medical | 21 May 2026 |
| 10 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 71839-141-10 | BE Pharmaceuticals | 12 July 2023 |
| 10 vial in 1 box / 5 mL in 1 vial | 0143-9250-10 | Hikma Pharmaceuticals | 30 April 2017 |
| 10 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 67457-228-05 | Mylan Institutional | 6 February 2012 |
| 10 vial in 1 tray / 5 mL in 1 vial | 81565-204-02 | Phlow | 8 February 2022 |
| 10 vial in 1 carton / 5 mL in 1 vial | 25021-687-05 | Sagent Pharmaceuticals | 15 October 2023 |
| 10 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 0781-3220-95 | Sandoz | 5 December 2008 |
| 10 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 42677-309-10 | Shandong New Time Pharmaceutical | 12 July 2024 |
| 10 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 43547-530-10 | Solco Healthcare | 25 July 2021 |
| 10 vial in 1 carton / 5 mL in 1 vial | 39822-4200-2 | XGen Pharmaceuticals DJB | 1 December 2012 |
| 1 vial in 1 bag / 5 mL in 1 vial | 71872-7036-1 | Medical Purchasing Solutions | 28 February 2018 |
| 1 vial, multi-dose in 1 bag / 5 mL in 1 vial, multi-dose | 71872-7207-1 | Medical Purchasing Solutions | 19 February 2020 |
| 1 vial in 1 bag / 5 mL in 1 vial | 71872-7262-1 | Medical Purchasing Solutions | 2 August 2021 |
| 1 vial in 1 bag / 5 mL in 1 vial | 71872-7317-1 | Medical Purchasing Solutions | 1 January 2024 |
| 1 vial, multi-dose in 1 bag / 5 mL in 1 vial, multi-dose | 71872-7344-1 | Medical Purchasing Solutions | 6 March 2025 |
| 5 mL in 1 vial, multi-dose | 51662-1354-1 | HealthFirst | 8 February 2019 |
| 5 mL in 1 vial, multi-dose | 51662-1546-1 | HealthFirst | 18 July 2021 |
| 5 mL in 1 vial, multi-dose | 51662-1640-1 | HealthFirst | 17 July 2023 |
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 17 March 1994 | 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
Other strengths and forms of Rocuronium
Clinical summary
Rocuronium is a nondepolarizing neuromuscular blocker indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. MedsAcross supplies Rocuronium 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 RocuroniumFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Rocuronium prescribing information (Fresenius Kabi) · U.S. National Library of Medicine, DailyMed
Need Rocuronium 50 mg/5 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.