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Medicine

Aztreonam 2 g powder for injection

Aztreonam · Intramuscular, intravenous
Available on requestPrescription onlyUS FDAGeneric name

Aztreonam 2 g powder for injection is a generic prescription medicine for intramuscular, intravenous use, made by 2 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 in original package at 20°C to 25°C (68°F to 77°F)., avoid excessive heat.

Key facts

Active ingredient (INN)
Aztreonam
Brand
Sold under the generic name
Strength
2 g
Dosage form
Powder for injection
Route
Intramuscular, intravenous
Packs
10 vials and 1 more
Manufacturers
Fresenius KabiHospira
Origin register
US FDA, United States
Storage
Store in original package at 20°C to 25°C (68°F to 77°F)., avoid excessive heat.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
J01DF01 Aztreonam
HS code (indicative)
3004.20Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
5 November 2009
Identifiers
RxCUI 1664981, 1664986DailyMed set ID d4500795-3b07-4a7d-b432-73cafbb3dbc6, 302fd27d-0a22-44ea-91fb-1b1ffcf17a1f, 5f5ebb63-6ac5-4fb4-bcc1-d069c123eb18 +1NDC 0409-0830, 63323-402Application ANDA206517, ANDA065439

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 in 1 tray / 1 injection, powder, lyophilized, for solution in 1 vial63323-402-20Fresenius Kabi5 November 2009
10 vial in 1 tray / 1 injection, powder, lyophilized, for solution in 1 vial63323-402-24Fresenius Kabi5 November 2009
10 vial in 1 tray / 1 injection, powder, lyophilized, for solution in 1 vial63323-402-30Fresenius Kabi5 November 2009
10 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose0409-0830-01Hospira24 January 2022

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 31 December 1986Drugs@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 Aztreonam 2 g powder for injection.

Compare 1

Other strengths and forms of Aztreonam

Clinical summary

Aztreonam is a monobactam antibacterial indicated for the treatment of infections caused by susceptible Gram-negative microorganisms. It is available as powder for injection and kits for intramuscular and intravenous use. MedsAcross supplies Aztreonam 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 Aztreonam

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

Data sources

Need Aztreonam 2 g powder for 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.