Medicine
Micafungin 100 mg powder for injection
Micafungin 100 mg powder for injection is a generic prescription medicine for intravenous use, made by 3 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
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store the reconstituted product at 25°C (77°F). Store the diluted solution at…
Key facts
- Active ingredient (INN)
- Micafungin
- Brand
- Sold under the generic name
- Strength
- 100 mg
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 10 cartons, 1 vial, 10 boxes and 2 more
- Manufacturers
- Fresenius KabiHisun PharmaceuticalsHikma Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- 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
- 8 May 2020
- Identifiers
- RxCUI 861383, 861379DailyMed set ID f8198836-4011-40b9-af25-466ae08727f8, 8ba6f80c-05f0-4d75-930c-c8458db2e1c1, dc5241be-4b85-4f04-8553-9819603373b8 +1NDC 63323-729, 0143-9362, 42658-023Application ANDA207344, ANDA213261, ANDA219712
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.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 10 carton in 1 carton / 1 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose | 63323-729-10 | Fresenius Kabi | 8 May 2020 |
| 10 carton in 1 carton / 1 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose | 63323-729-12 | Fresenius Kabi | 8 May 2020 |
| 1 vial in 1 carton / 5 injection, powder, lyophilized, for solution in 1 vial | 0143-9362-01 | Hikma Pharmaceuticals | 9 July 2021 |
| 1 vial in 1 box, unit-dose / 1 injection, powder, for solution in 1 vial | 42658-023-01 | Hisun Pharmaceuticals | 1 April 2026 |
| 10 box in 1 carton / 1 vial in 1 box / 1 injection, powder, for solution in 1 vial | 42658-023-02 | Hisun Pharmaceuticals | 1 April 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.
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 MicafunginFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Micafungin in Sodium Chloride prescribing information (Baxter Healthcare) · U.S. National Library of Medicine, DailyMed
- Mycamine: European public assessment report (EPAR) · European Medicines Agency
Need Micafungin 100 mg 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.