Medicine
Spironolactone 25 mg/5 mL oral suspension
Spironolactone 25 mg/5 mL oral suspension is a generic prescription medicine for oral use, made by 5 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 between 15° to 30°C…
Key facts
- Active ingredient (INN)
- Spironolactone
- Brand
- Sold under the generic name
- Strength
- 25 mg/5 mL
- Dosage form
- Oral suspension
- Route
- Oral
- Packs
- 118 mL, 473 mL, 10 cup and 16 more
- Manufacturers
- Camber PharmaceuticalsIndiaAtlantic BiologicalsCMP PharmaPadagisAmneal Pharmaceuticals NY
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted between 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
- C03DA01 Spironolactone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 4 August 2017
- Identifiers
- RxCUI 104232DailyMed set ID 1ed9a2cb-d666-43db-b515-f9615fa6da25, c4f70a04-7d89-4b73-8b02-17d43471bf08, 522bd365-ddcc-48f4-8a98-66dc4c3bb314 +3NDC 69238-2027, 46287-020, 0574-1133 +3Application ANDA215572, NDA209478, ANDA218085
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 |
|---|---|---|---|
| 118 mL in 1 bottle | 31722-691-11 | Camber PharmaceuticalsIndia | 21 February 2025 |
| 473 mL in 1 bottle | 31722-691-47 | Camber PharmaceuticalsIndia | 21 February 2025 |
| 473 mL in 1 bottle | 69238-2027-2 | Amneal Pharmaceuticals NY | 8 September 2023 |
| 118 mL in 1 bottle | 69238-2027-8 | Amneal Pharmaceuticals NY | 8 September 2023 |
| 473 mL in 1 bottle | 46287-020-01 | CMP Pharma | 4 August 2017 |
| 118 mL in 1 bottle | 46287-020-04 | CMP Pharma | 4 August 2017 |
| 10 cup, unit-dose in 1 carton / 5 mL in 1 cup, unit-dose | 46287-020-50 | CMP Pharma | 15 July 2021 |
| 118 mL in 1 bottle | 0574-1133-04 | Padagis | 31 October 2023 |
| 10 cup, unit-dose in 1 carton / 5 mL in 1 cup, unit-dose | 0574-1133-10 | Padagis | 31 October 2023 |
| 473 mL in 1 bottle | 0574-1133-16 | Padagis | 31 October 2023 |
| 1 syringe in 1 bag / 2.5 mL in 1 syringe | 17856-1133-1 | Atlantic Biologicals | 3 June 2024 |
| 1 syringe in 1 bag / 2.5 mL in 1 syringe | 17856-1133-4 | Atlantic Biologicals | 26 September 2025 |
| 120 syringe in 1 case / 1 mL in 1 syringe | 17856-1133-5 | Atlantic Biologicals | 30 April 2026 |
| 120 syringe in 1 case / 3 mL in 1 syringe | 17856-1133-6 | Atlantic Biologicals | 30 April 2026 |
| 1 syringe in 1 bag / 1 mL in 1 syringe | 17856-1133-7 | Atlantic Biologicals | 2 July 2026 |
| 1 syringe in 1 bag / 3 mL in 1 syringe | 17856-1133-8 | Atlantic Biologicals | 2 July 2026 |
| 110 syringe in 1 case / 1 mL in 1 syringe | 17856-1233-1 | Atlantic Biologicals | 28 August 2026 |
| 45 syringe in 1 case / 2.5 mL in 1 syringe | 17856-1233-2 | Atlantic Biologicals | 28 August 2026 |
| 110 syringe in 1 case / 3 mL in 1 syringe | 17856-1233-3 | Atlantic Biologicals | 28 August 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.
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 Spironolactone
Clinical summary
Spironolactone is an aldosterone antagonist indicated for the treatment of NYHA Class III–IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure. MedsAcross supplies Spironolactone 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 SpironolactoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Aldactone prescribing information (Pfizer Laboratories) · U.S. National Library of Medicine, DailyMed
- Qaialdo: European public assessment report (EPAR) · European Medicines Agency
Need Spironolactone 25 mg/5 mL 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.