Medicine
Fludrocortisone 0.1 mg tablet
Fludrocortisone 0.1 mg tablet is a generic prescription medicine for oral use, made by 15 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).
Key facts
- Active ingredient (INN)
- Fludrocortisone
- Brand
- Sold under the generic name
- Strength
- 0.1 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 1000 tablets and 23 more
- Manufacturers
- Viona PharmaceuticalsIndiaZydus LifesciencesIndiaAmneal Pharmaceuticals of New YorkNovitium PharmaAmerican Health PackagingAmneal Pharmaceuticals NYCardinal HealthEywa PharmaMajor PharmaceuticalsAvKARE
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- H02AA02 Fludrocortisone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 18 March 2002
- Identifiers
- RxCUI 313979DailyMed set ID 3d6f1a89-ea11-474d-aaca-64fea02a3beb, eff2eae8-94ce-46ca-a027-6b1d08e7b96b, bc92f5c6-3a65-4fab-85b3-fd5b84f917c1 +13NDC 71335-2454, 71930-088, 72578-164 +13Application ANDA215279, ANDA220308, ANDA219251 +1
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 |
|---|---|---|---|
| 100 tablet in 1 bottle | 72578-164-01 | Viona PharmaceuticalsIndia | 2 December 2024 |
| 500 tablet in 1 bottle | 72578-164-05 | Viona PharmaceuticalsIndia | 2 December 2024 |
| 100 tablet in 1 bottle | 70771-1893-1 | Zydus LifesciencesIndia | 2 December 2024 |
| 500 tablet in 1 bottle | 70771-1893-5 | Zydus LifesciencesIndia | 2 December 2024 |
| 100 tablet in 1 bottle | 69238-7033-1 | Amneal Pharmaceuticals NY | 18 March 2002 |
| 500 tablet in 1 bottle | 69238-7033-5 | Amneal Pharmaceuticals NY | 18 March 2002 |
| 100 tablet in 1 bottle | 0115-7033-01 | Amneal Pharmaceuticals of New York | 18 March 2002 |
| 500 tablet in 1 bottle | 0115-7033-02 | Amneal Pharmaceuticals of New York | 18 March 2002 |
| 1000 tablet in 1 bottle | 0115-7033-03 | Amneal Pharmaceuticals of New York | 18 March 2002 |
| 100 tablet in 1 bottle | 71930-088-12 | Eywa Pharma | 2 June 2025 |
| 500 tablet in 1 bottle | 71930-088-52 | Eywa Pharma | 2 June 2025 |
| 30 tablet in 1 bottle | 70954-252-10 | Novitium Pharma | 2 June 2022 |
| 100 tablet in 1 bottle | 70954-252-20 | Novitium Pharma | 2 June 2022 |
| 500 tablet in 1 bottle | 70954-252-30 | Novitium Pharma | 2 June 2022 |
| 10 blister pack in 1 bag / 1 tablet in 1 blister pack | 55154-2644-0 | Cardinal Health | 25 February 2025 |
| 10 blister pack in 1 bag / 1 tablet in 1 blister pack | 55154-6645-0 | Cardinal Health | 9 May 2008 |
| 100 blister pack in 1 box, unit-dose / 1 tablet in 1 blister pack | 68084-288-01 | American Health Packaging | 5 September 2008 |
| 50 blister pack in 1 carton / 1 tablet in 1 blister pack | 68084-288-65 | American Health Packaging | 9 February 2023 |
| 100 tablet in 1 bottle | 42291-764-01 | AvKARE | 13 January 2021 |
| 50 blister pack in 1 box, unit-dose / 1 tablet in 1 blister pack | 50268-330-15 | AvPAK | 1 August 2011 |
| 100 tablet in 1 bottle | 71335-2454-1 | Bryant Ranch Prepack | 30 July 2024 |
| 100 tablet in 1 bottle | 51407-705-01 | Golden State Medical Supply | 10 June 2025 |
| 50 blister pack in 1 carton / 1 tablet in 1 blister pack | 0904-7317-06 | Major Pharmaceuticals | 4 September 2024 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 0904-7317-61 | Major Pharmaceuticals | 4 September 2024 |
| 100 tablet in 1 bottle | 72603-170-01 | NorthStar Rx | 7 September 2023 |
| 30 tablet in 1 blister pack | 0615-6562-39 | Vangard Labs | 7 October 2020 |
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 18 August 1955 | 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
Clinical summary
Fludrocortisone is a prescription medicine indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison’s disease and for the treatment of salt-losing adrenogenital syndrome. It is available as tablets for oral use. MedsAcross supplies Fludrocortisone 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 FludrocortisoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- fludrocortisone acetate prescribing information (Eywa Pharma) · U.S. National Library of Medicine, DailyMed
Need Fludrocortisone 0.1 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.