Medicine
Fluconazole 10 mg/mL powder for oral suspension
Fluconazole 10 mg/mL powder for oral suspension is a generic prescription medicine for oral use, made by 4 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
Protect from freezing. Store dry powder at 20° to 25°C (68° to 77°F). After…
Key facts
- Active ingredient (INN)
- Fluconazole
- Brand
- Sold under the generic name
- Strength
- 10 mg/mL
- Dosage form
- Powder for oral suspension
- Route
- Oral
- Packs
- 1 bottle and 1 more
- Manufacturers
- Aurobindo PharmaIndiaMylan PharmaceuticalsNorthStar RxRising Pharma Holdings
- Origin register
- US FDA, United States
- Storage
- Protect from freezing. Store dry powder at 20° to 25°C (68° to 77°F). After Reconstitution: Store reconstituted suspension between 5°C (41°F) and 25°C (77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D01AC15 Fluconazole
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 December 1993
- Identifiers
- RxCUI 310352, 310353, 197698 +3DailyMed set ID ccbe0991-27a1-4ddb-bfc7-1b3422e53390, bf588f7e-89de-4b4e-8d33-c1ff2be1b34e, afde17e7-b95b-4cd5-97eb-e361724014bd +1NDC 57237-149, 65862-299, 16714-695 +1Application ANDA079150, NDA020090
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 |
|---|---|---|---|
| 1 bottle in 1 carton / 35 mL in 1 bottle | 65862-299-35 | Aurobindo PharmaIndia | 18 September 2009 |
| 1 bottle in 1 carton / 35 mL in 1 bottle | 59762-5029-1 | Mylan Pharmaceuticals | 23 December 1993 |
| 1 bottle in 1 carton / 35 mL in 1 bottle | 57237-149-35 | Rising Pharma Holdings | 18 September 2009 |
| 1 bottle in 1 carton / 35 mL in 1 bottle | 16714-695-01 | NorthStar Rx | 18 September 2009 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 29 January 1990 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US 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 Fluconazole
Clinical summary
Fluconazole is an azole antifungal indicated for the treatment of 1. It is available as tablets, injection and powder for oral suspension for intravenous use. MedsAcross supplies Fluconazole 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 FluconazoleFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Fluconazole prescribing information (Mylan Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Fluconazole 10 mg/mL powder for oral suspension 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.