Medicine
Diflucan 1400 mg/35 mL powder for oral suspension
Diflucan 1400 mg/35 mL powder for oral suspension is a prescription medicine containing Fluconazole for oral use, marketed by Roerig, 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 tablets below 30°C (86°F). DIFLUCAN for Oral…
Key facts
- Active ingredient (INN)
- Fluconazole
- Brand
- Diflucan
- Strength
- 1400 mg/35 mL
- Dosage form
- Powder for oral suspension
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Roerig
- Manufacturer
- Roerig
- Origin register
- US FDA, United States
- Storage
- Protect from freezing. Store tablets below 30°C (86°F). DIFLUCAN for Oral Suspension: DIFLUCAN for Oral Suspension is supplied as an orange-flavored powder to provide 35 mL per bottle as follows: NDC 0049-3440-19 Fluconazole 350 mg per bottle NDC 0049-3450-19 Fluconazole 1400 mg per bottle Storage: Store dry powder below 30°C (86°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 197698, 197699, 197700 +7DailyMed set ID f694c617-3383-416c-91b6-b94fda371204NDC 0049-3450Application 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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 35 mL in 1 bottle | 0049-3450-19 | Roerig | 23 December 1993 |
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 Diflucan 1400 mg/35 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.