Medicine
Fluconazole 50 mg tablet
Fluconazole 50 mg tablet is a generic prescription medicine for oral use, made by 16 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 at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Fluconazole
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 30 tablets, 10 blister pack and 48 more
- Manufacturers
- Zydus LifesciencesIndiaDr. Reddy's LaboratoriesIndiaGlenmark PharmaceuticalsIndiaAurobindo PharmaIndiaSportpharmAsclemedBryant Ranch PrepackANI PharmaceuticalsChartwell RXRadha Pharmaceuticals16 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 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
- 29 July 2004
- Identifiers
- RxCUI 197698, 197699, 197700 +1DailyMed set ID 6ebf24fd-41cd-4b3c-8176-a1436253ba2d, 3da5f41d-5200-45ac-b89d-00881237ec85, 2c9abaee-461f-437d-adda-e96d7ae3dd01 +15NDC 65862-058, 68462-101, 72162-1776 +16Application ANDA077731, ANDA077253, ANDA078423 +3
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
A sample of 40 packs from 16 labelers. The register lists 51 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 70710-1137-1 | Zydus LifesciencesIndia | 6 April 2017 |
| 30 tablet in 1 bottle | 70710-1137-3 | Zydus LifesciencesIndia | 6 April 2017 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 70710-1137-4 | Zydus LifesciencesIndia | 6 April 2017 |
| 500 tablet in 1 bottle | 70710-1137-5 | Zydus LifesciencesIndia | 6 April 2017 |
| 100 tablet in 1 bottle | 70771-1063-1 | Zydus LifesciencesIndia | 6 April 2017 |
| 30 tablet in 1 bottle | 70771-1063-3 | Zydus LifesciencesIndia | 6 April 2017 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 70771-1063-4 | Zydus LifesciencesIndia | 6 April 2017 |
| 500 tablet in 1 bottle | 70771-1063-5 | Zydus LifesciencesIndia | 6 April 2017 |
| 30 tablet in 1 bottle | 65862-058-30 | Aurobindo PharmaIndia | 7 October 2008 |
| 100 tablet in 1 bottle | 55111-143-01 | Dr. Reddy's LaboratoriesIndia | 20 June 2014 |
| 500 tablet in 1 bottle | 55111-143-05 | Dr. Reddy's LaboratoriesIndia | 20 June 2014 |
| 30 tablet in 1 bottle | 55111-143-30 | Dr. Reddy's LaboratoriesIndia | 20 June 2014 |
| 10 dose pack in 1 carton / 10 tablet in 1 dose pack | 55111-143-78 | Dr. Reddy's LaboratoriesIndia | 20 June 2014 |
| 1000 tablet in 1 bottle | 68462-101-10 | Glenmark PharmaceuticalsIndia | 25 January 2006 |
| 30 tablet in 1 bottle | 68462-101-30 | Glenmark PharmaceuticalsIndia | 25 January 2006 |
| 30 tablet in 1 bottle | 62559-990-30 | ANI Pharmaceuticals | 22 April 2021 |
| 30 tablet in 1 bottle | 62135-130-30 | Chartwell RX | 8 December 2022 |
| 30 tablet in 1 bottle | 77771-396-30 | Radha Pharmaceuticals | 10 December 2025 |
| 30 tablet in 1 bottle | 57237-003-30 | Rising Pharma Holdings | 7 October 2008 |
| 30 tablet in 1 bottle | 63629-8970-1 | Bryant Ranch Prepack | 8 October 2024 |
| 30 tablet in 1 bottle | 72162-1776-2 | Bryant Ranch Prepack | 23 January 2026 |
| 10 dose pack in 1 carton / 10 tablet in 1 dose pack | 85766-101-00 | Sportpharm | 10 October 2025 |
| 100 tablet in 1 bottle | 85766-101-01 | Sportpharm | 10 October 2025 |
| 500 tablet in 1 bottle | 85766-101-05 | Sportpharm | 10 October 2025 |
| 10 tablet in 1 bottle | 85766-101-10 | Sportpharm | 10 October 2025 |
| 12 tablet in 1 bottle | 85766-101-12 | Sportpharm | 10 October 2025 |
| 20 tablet in 1 bottle | 85766-101-20 | Sportpharm | 10 October 2025 |
| 30 tablet in 1 bottle | 85766-101-30 | Sportpharm | 10 October 2025 |
| 60 tablet in 1 bottle | 85766-101-60 | Sportpharm | 10 October 2025 |
| 90 tablet in 1 bottle | 85766-101-90 | Sportpharm | 10 October 2025 |
| 1 tablet in 1 bottle | 85766-156-01 | Sportpharm | 9 February 2026 |
| 7 tablet in 1 bottle | 85766-156-07 | Sportpharm | 9 February 2026 |
| 10 tablet in 1 bottle | 85766-156-10 | Sportpharm | 9 February 2026 |
| 14 tablet in 1 bottle | 85766-156-14 | Sportpharm | 9 February 2026 |
| 20 tablet in 1 bottle | 85766-156-20 | Sportpharm | 9 February 2026 |
| 30 tablet in 1 bottle | 85766-156-30 | Sportpharm | 9 February 2026 |
| 60 tablet in 1 bottle | 85766-156-60 | Sportpharm | 9 February 2026 |
| 90 tablet in 1 bottle | 85766-156-90 | Sportpharm | 9 February 2026 |
| 1 tablet in 1 bottle | 87063-203-01 | Asclemed | 13 May 2026 |
| 7 tablet in 1 bottle | 87063-203-07 | Asclemed | 13 May 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.
| 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 50 mg tablet 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.