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Medicine

Micafungin 20 mg/mL powder for injection

Micafungin · Intravenous
Available on requestPrescription onlyUS FDAGeneric name

Micafungin 20 mg/mL powder for injection is a generic prescription medicine for intravenous use, made by 6 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 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C…

Key facts

Active ingredient (INN)
Micafungin
Brand
Sold under the generic name
Strength
20 mg/mL
Dosage form
Powder for injection
Route
Intravenous
Packs
1 vial, 10 vials, 20 vials and 11 more
Manufacturers
Zydus LifesciencesIndiaGlenmark PharmaceuticalsIndiaBioconIndiaSagent PharmaceuticalsMeitheal PharmaceuticalsQilu Pharmaceutical
Origin register
US FDA, United States
Storage
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store the reconstituted product at 25°C (77°F) Store the diluted solution at 25°C (77°F) Protect from light.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
J02AX05 Micafungin
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
15 June 2021
Identifiers
RxCUI 861379, 861383DailyMed set ID 653f8c75-b5b8-41ea-8b33-5baad1680bda, 29f17423-5787-47d0-a83b-bbdc0198fbfa, 72bc5dd6-6052-4483-9b13-afdeaaa8cc69 +4NDC 67184-0590, 70710-1725, 70771-1684 +4Application ANDA219273, ANDA215241, ANDA215381 +2

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
1 vial in 1 carton / 5 mL in 1 vial70710-1725-1Zydus LifesciencesIndia20 August 2024
10 vial in 1 carton / 5 mL in 1 vial70710-1725-6Zydus LifesciencesIndia10 April 2023
1 vial in 1 carton / 5 mL in 1 vial70771-1684-1Zydus LifesciencesIndia20 August 2024
10 vial in 1 carton / 5 mL in 1 vial70771-1684-6Zydus LifesciencesIndia10 April 2023
10 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose70377-076-91BioconIndia1 June 2025
1 vial in 1 carton / 5 mL in 1 vial68462-772-01Glenmark PharmaceuticalsIndia30 June 2025
10 vial in 1 carton / 5 mL in 1 vial68462-772-10Glenmark PharmaceuticalsIndia30 June 2025
10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose71288-029-11Meitheal Pharmaceuticals28 September 2022
1 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose71288-029-12Meitheal Pharmaceuticals1 November 2024
1 vial in 1 carton / 5 mL in 1 vial67184-0590-1Qilu Pharmaceutical3 April 2025
10 vial in 1 carton / 5 mL in 1 vial67184-0590-2Qilu Pharmaceutical3 April 2025
1 vial in 1 carton / 5 mL in 1 vial25021-191-10Sagent Pharmaceuticals15 June 2021
10 vial in 1 carton / 5 mL in 1 vial25021-191-11Sagent Pharmaceuticals15 September 2022
20 vial in 1 carton / 5 mL in 1 vial25021-191-12Sagent Pharmaceuticals1 November 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 16 March 2005Drugs@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

Other strengths and forms of Micafungin

Clinical summary

Micafungin is an echinocandin antifungal indicated for treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult, among other approved uses. It is available as powder for injection and injection for intravenous use. MedsAcross supplies Micafungin 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 Micafungin

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

Data sources

Need Micafungin 20 mg/mL 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.