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Medicine

Sugammadex 500 mg/5 mL injection

Sugammadex · Intravenous
Available on requestPrescription onlyUS FDAGeneric name

Sugammadex 500 mg/5 mL injection is a generic prescription medicine for intravenous use, made by 19 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

Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F)…

Key facts

Active ingredient (INN)
Sugammadex
Brand
Sold under the generic name
Strength
500 mg/5 mL
Dosage form
Injection
Route
Intravenous
Packs
10 vials of 5 mL, 10 syringes of 5 mL and 17 more
Manufacturers
Zydus LifesciencesIndiaAccord HealthcareIndiaCamber PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaGland PharmaIndiaGlenmark PharmaceuticalsIndiaLupinIndiaNovadoz PharmaceuticalsIndiaSteriscience SpecialtiesIndiaSun Pharmaceutical IndustriesIndia
Origin register
US FDA, United States
Storage
Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light. When not protected from light, the vial should be used within 5 days.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
V03AB35 Sugammadex
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
1 May 2025
Identifiers
RxCUI 1727000, 1726992, 2748156 +1DailyMed set ID c451d4dc-03f8-48d9-a848-6b2905122aa4, 57bf9b96-0550-b8e4-e063-6294a90a317b, 9f2e66d7-a5d2-4593-bb30-6d4a418381aa +17NDC 55579-893, 16729-727, 70748-371 +17Application ANDA215260, ANDA214306, ANDA214338 +11

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, single-dose in 1 carton / 5 mL in 1 vial, single-dose70710-1651-6Zydus LifesciencesIndia2 July 2026
10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose70771-1857-6Zydus LifesciencesIndia2 July 2026
10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose16729-727-03Accord HealthcareIndia4 August 2026
10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose31722-255-10Camber PharmaceuticalsIndia27 July 2026
10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose43598-925-37Dr. Reddy's LaboratoriesIndia28 July 2026
10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose68083-442-10Gland PharmaIndia28 July 2026
10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose68462-696-50Glenmark PharmaceuticalsIndia28 July 2026
10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose70748-371-02LupinIndia28 July 2026
10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose72205-479-02Novadoz PharmaceuticalsIndia28 July 2026
10 syringe in 1 carton / 5 mL in 1 syringe82449-242-02Steriscience SpecialtiesIndia28 July 2026
10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose62756-079-04Sun Pharmaceutical IndustriesIndia28 July 2026
10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose72266-269-10Fosun Pharma29 July 2026
10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose83301-0078-2Mullan Pharmaceutical2 November 2026
10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose67457-970-05Mylan Institutional28 July 2026
10 syringe in 1 carton / 5 mL in 1 syringe42023-935-10Par Health28 July 2026
10 vial in 1 carton / 5 mL in 1 vial25021-619-05Sagent Pharmaceuticals1 July 2026
10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose0781-3469-95Sandoz28 July 2026
10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose42677-312-10Shandong New Time Pharmaceutical1 May 2025
10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose55579-893-10Solupharm Pharmazeutische Erzeugnisse28 July 2026
10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose70069-893-10Somerset Therapeutics28 July 2026

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 15 December 2015Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
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 Sugammadex 500 mg/5 mL injection.

Compare 1

Other strengths and forms of Sugammadex

Clinical summary

Sugammadex is a prescription medicine indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients undergoing surgery. It is available as injection for intravenous use. MedsAcross supplies Sugammadex 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 Sugammadex

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

Data sources

Need Sugammadex 500 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.