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Medicine

Rocuronium 100 mg/10 mL injection

Rocuronium · Intravenous
Available on requestPrescription onlyUS FDA Cold chainGeneric name

Rocuronium 100 mg/10 mL injection is a generic prescription medicine for intravenous use, made by 21 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

Available on request

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 available in the following: 50 mg/5 mL (10…

Key facts

Active ingredient (INN)
Rocuronium
Brand
Sold under the generic name
Strength
100 mg/10 mL
Dosage form
Injection
Route
Intravenous
Packs
10 vials of 10 mL, 1 vial of 10 mL, 5 cartons of 10 mL and 32 more
Manufacturers
Lifestar PharmaIndiaCaplin SterilesIndiaEugiaIndiaGland PharmaIndiaPiramal Critical CareIndiaHealthFirstHospiraMedical Purchasing SolutionsFresenius KabiBaxter Healthcare
Origin register
US FDA, United States
Storage
Rocuronium bromide injection is available in the following: 50 mg/5 mL (10 mg/mL) NDC 0781-3220-95 multiple-dose vials of 5 mL in boxes of 10 100 mg/10 mL (10 mg/mL) NDC 0781-3220-92 multiple-dose vials of 10 mL in boxes of 10 Rocuronium bromide should be stored in a refrigerator, 2° to 8°C (36° to 46°F). DO NOT FREEZE.
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, 2740933, 2754335 +2DailyMed set ID cb28d869-6510-4402-9462-f6bb25fa0fa8, 42da65ee-2402-7b51-e063-6394a90a46b7, a18fce42-0f3d-4354-845e-57c37ac3a147 +30NDC 0781-3220, 84549-131, 43066-509 +29Application ANDA079195, ANDA216234, ANDA219260 +13

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, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose65145-131-10Caplin SterilesIndia3 October 2024
10 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose55150-226-10EugiaIndia12 April 2017
10 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose68083-365-10Gland PharmaIndia18 May 2018
10 vial in 1 carton / 10 mL in 1 vial70756-670-10Lifestar PharmaIndia29 May 2025
1 vial in 1 carton / 10 mL in 1 vial70756-670-86Lifestar PharmaIndia29 May 2025
10 vial in 1 carton / 10 mL in 1 vial66794-229-41Piramal Critical CareIndia20 July 2020
10 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose0409-5160-10Hospira28 August 2023
10 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose0409-7037-10Hospira17 July 2023
10 vial, multi-dose in 1 box / 10 mL in 1 vial, multi-dose0409-9558-10Hospira1 December 2008
10 vial, multi-dose in 1 box / 10 mL in 1 vial, multi-dose0409-9558-50Hospira15 December 2008
10 vial in 1 tray / 10 mL in 1 vial63323-426-10Fresenius Kabi13 December 2009
10 vial in 1 tray / 10 mL in 1 vial65219-444-10Fresenius Kabi11 October 2023
10 vial in 1 tray / 10 mL in 1 vial65219-697-10Fresenius Kabi11 October 2023
10 vial in 1 carton / 10 mL in 1 vial43066-013-10Baxter Healthcare15 July 2019
5 carton in 1 carton / 1 syringe, plastic in 1 carton / 10 mL in 1 syringe, plastic43066-509-05Baxter Healthcare18 September 2026
10 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose71288-718-11Meitheal Pharmaceuticals8 May 2023
10 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose71288-718-92Meitheal Pharmaceuticals8 May 2023
10 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose71839-142-10BE Pharmaceuticals12 July 2023
10 vial in 1 box / 10 mL in 1 vial0143-9251-10Hikma Pharmaceuticals30 April 2017
10 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose67457-228-10Mylan Institutional6 February 2012
10 vial in 1 carton / 10 mL in 1 vial25021-687-10Sagent Pharmaceuticals15 October 2023
10 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose0781-3220-92Sandoz5 December 2008
10 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose42677-310-10Shandong New Time Pharmaceutical12 July 2024
10 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose43547-531-10Solco Healthcare25 July 2021
10 vial in 1 carton / 10 mL in 1 vial39822-4200-6XGen Pharmaceuticals DJB1 December 2012
10 mL in 1 vial, multi-dose51662-1355-1HealthFirst10 February 2019
10 mL in 1 vial, multi-dose51662-1545-1HealthFirst9 April 2022
10 mL in 1 vial, multi-dose51662-1641-1HealthFirst17 July 2023
10 mL in 1 vial51662-1710-1HealthFirst30 April 2017
1 vial in 1 bag / 10 mL in 1 vial71872-7309-1Medical Purchasing Solutions8 September 2023
1 vial in 1 bag / 10 mL in 1 vial71872-7349-1Medical Purchasing Solutions21 April 2025
1 vial, multi-dose in 1 bag / 10 mL in 1 vial, multi-dose71872-7372-1Medical Purchasing Solutions16 April 2026
1 vial, multi-dose in 1 bag / 10 mL in 1 vial, multi-dose71872-7379-1Medical Purchasing Solutions29 September 2026
10 vial in 1 carton / 10 mL in 1 vial72572-651-10Civica16 December 2020
10 mL in 1 vial, multi-dose84549-131-10ProPharma Distribution10 October 2025

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 17 March 1994Drugs@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

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 Rocuronium

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

Data sources

Need Rocuronium 100 mg/10 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.