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Medicine

Linezolid 600 mg/300 mL injection

Linezolid · Intravenous
Available on requestPrescription onlyUS FDAGeneric name

Linezolid 600 mg/300 mL injection is a generic prescription medicine for intravenous use, made by 9 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

Protect containers from freezing. Store at 20 to 25°C (68 to 77°F), excursions…

Key facts

Active ingredient (INN)
Linezolid
Brand
Sold under the generic name
Strength
600 mg/300 mL
Dosage form
Injection
Route
Intravenous
Packs
10 bags of 300 mL, 10 pouches of 300 mL, 300 mL and 7 more
Manufacturers
Piramal Critical CareIndiaCaplin SterilesIndiaEugiaIndiaSun Pharmaceutical IndustriesIndiaFresenius KabiHikma PharmaceuticalsHospiraHp Halden PharmaSandoz
Origin register
US FDA, United States
Storage
Protect containers from freezing. Store at 20 to 25°C (68 to 77°F), excursions permitted to 15 to 30°C (59 to 86°F). Protect from light.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
J01XX08 Linezolid
HS code (indicative)
3004.20Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
18 June 2015
Identifiers
RxCUI 1662285, 1662278DailyMed set ID c401f1a8-cc37-461b-bfef-f2e156629bf8, 2220c753-e0e8-4797-bce2-34b3c63bd631, 870c9600-04d5-4b44-a5b5-02252a310f22 +7NDC 0409-4883, 65145-181, 57664-683 +7Application NDA206473, ANDA219558, ANDA207354 +5

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 bag in 1 carton / 300 mL in 1 bag66794-219-43Piramal Critical CareIndia8 March 2024
10 bag in 1 carton / 300 mL in 1 bag66794-236-43Piramal Critical CareIndia8 March 2024
10 pouch in 1 case / 1 bag in 1 pouch / 300 mL in 1 bag65145-181-10Caplin SterilesIndia23 December 2025
10 pouch in 1 carton / 1 bag in 1 pouch / 300 mL in 1 bag55150-242-51EugiaIndia4 August 2016
10 bag in 1 box / 300 mL in 1 bag57664-683-57Sun Pharmaceutical IndustriesIndia1 February 2017
10 bag in 1 case / 300 mL in 1 bag63323-713-13Fresenius Kabi22 June 2015
10 pouch in 1 box / 1 bag in 1 pouch / 300 mL in 1 bag0143-9534-10Hikma Pharmaceuticals27 December 2022
10 pouch in 1 case / 1 bag in 1 pouch / 300 mL in 1 bag0409-4883-10Hospira19 June 2023
300 mL in 1 bag66298-7131-3Hp Halden Pharma27 July 2017
10 bag in 1 carton / 300 mL in 1 bag0781-3433-95Sandoz15 June 2016

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 18 April 2000Drugs@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 Linezolid 600 mg/300 mL injection.

Compare 1

Other strengths and forms of Linezolid

Clinical summary

Linezolid is an oxazolidinone antibacterial indicated in adults and children for the treatment of infections caused by susceptible Gram-positive bacteria, among other approved uses. It is available as tablets, injection and oral suspension for intravenous use. MedsAcross supplies Linezolid 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 Linezolid

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

Data sources

Need Linezolid 600 mg/300 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.