Medicine
Fluconazole 200 mg/100 mL injection
Fluconazole 200 mg/100 mL injection is a generic prescription medicine for intravenous 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 at 5º to 30ºC (41º to 86ºF). Fluconazole…
Key facts
- Active ingredient (INN)
- Fluconazole
- Brand
- Sold under the generic name
- Strength
- 200 mg/100 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 6 containers of 100 mL, 10 containers of 100 mL, 6 vials of 100 mL and 4 more
- Manufacturers
- Hikma PharmaceuticalsSagent PharmaceuticalsBaxter HealthcareHospira
- Origin register
- US FDA, United States
- Storage
- Protect from freezing. Store at 5º to 30ºC (41º to 86ºF). Fluconazole Injections in Plastic Containers: NDC 0143-9669-10 Fluconazole in Sodium Chloride Diluent 200 mg/100 mL Carton of 10 NDC 0143-9668-10 Fluconazole in Sodium Chloride Diluent 400 mg/200 mL Carton of 10 NDC 0143-9667-06 Fluconazole in Dextrose Diluent 200 mg/100 mL Carton of 6 NDC 0143-9666-06 Fluconazole in Dextrose Diluent 400…
- 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
- 29 July 2004
- Identifiers
- RxCUI 1721314, 1721315DailyMed set ID d3ca59bd-ae00-48ab-89aa-87c7f56e9989, cd24a261-9c15-42b4-8040-89d2dbda174e, c041227b-dab6-4c29-ab59-d31993d524b2 +2NDC 0143-9667, 0143-9899, 0338-6046 +3Application ANDA078764, ANDA076736, ANDA076766 +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.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 6 container in 1 carton / 100 mL in 1 container | 0143-9667-06 | Hikma Pharmaceuticals | 30 January 2012 |
| 10 container in 1 carton / 100 mL in 1 container | 0143-9669-10 | Hikma Pharmaceuticals | 30 January 2012 |
| 6 vial in 1 carton / 100 mL in 1 vial | 0143-9899-91 | Hikma Pharmaceuticals | 23 August 2005 |
| 10 pouch in 1 carton / 1 bag in 1 pouch / 100 mL in 1 bag | 25021-184-66 | Sagent Pharmaceuticals | 15 October 2019 |
| 10 pouch in 1 carton / 1 bag in 1 pouch / 100 mL in 1 bag | 25021-184-82 | Sagent Pharmaceuticals | 15 January 2018 |
| 10 bag in 1 carton / 100 mL in 1 bag | 0338-6046-48 | Baxter Healthcare | 29 July 2004 |
| 24 pouch in 1 carton / 1 bag in 1 pouch / 100 mL in 1 bag | 0409-3435-24 | Hospira | 6 January 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.
| 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 200 mg/100 mL 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.