Medicine
Hydrochlorothiazide and Spironolactone 25 mg/25 mg tablet
Hydrochlorothiazide and Spironolactone 25 mg/25 mg tablet is a generic prescription medicine for oral use, made by 7 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)
- Hydrochlorothiazide and Spironolactone
- Brand
- Sold under the generic name
- Strength
- 25 mg/25 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 1000 tablets and 23 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaBryant Ranch PrepackAdvagen PharmaMylan PharmaceuticalsMylan InstitutionalPrasco LaboratoriesSafecor Health
- 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
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 3 August 1979
- Identifiers
- RxCUI 198224DailyMed set ID c5258ea3-3aac-48fd-be5a-f8e4a47ca94a, f2a4fbc0-650b-440d-9555-c1720fe0fe35, 905568ae-ce27-4978-90c7-b5c93279ecd1 +9NDC 71335-2202, 42292-017, 63629-1069 +9Application ANDA089534, ANDA086513, NDA012616 +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, plastic | 53489-144-01 | Sun Pharmaceutical IndustriesIndia | 2 July 1987 |
| 500 tablet in 1 bottle, plastic | 53489-144-05 | Sun Pharmaceutical IndustriesIndia | 2 July 1987 |
| 1000 tablet in 1 bottle, plastic | 53489-144-10 | Sun Pharmaceutical IndustriesIndia | 2 July 1987 |
| 30 tablet in 1 bottle | 72888-040-01 | Advagen Pharma | 10 September 2026 |
| 100 tablet in 1 bottle | 72888-040-02 | Advagen Pharma | 10 September 2026 |
| 1000 tablet in 1 bottle | 72888-040-03 | Advagen Pharma | 10 September 2026 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 42292-017-20 | Mylan Institutional | 12 May 2017 |
| 100 tablet in 1 bottle, plastic | 0378-0403-01 | Mylan Pharmaceuticals | 3 August 1979 |
| 500 tablet in 1 bottle, plastic | 0378-0403-05 | Mylan Pharmaceuticals | 3 August 1979 |
| 100 tablet in 1 bottle, plastic | 63629-1068-1 | Bryant Ranch Prepack | 2 July 1987 |
| 500 tablet in 1 bottle, plastic | 63629-1069-1 | Bryant Ranch Prepack | 2 July 1987 |
| 30 tablet in 1 bottle, plastic | 63629-1071-1 | Bryant Ranch Prepack | 15 September 2020 |
| 60 tablet in 1 bottle, plastic | 63629-1071-2 | Bryant Ranch Prepack | 24 September 2020 |
| 1000 tablet in 1 bottle, plastic | 63629-1071-3 | Bryant Ranch Prepack | 21 September 2020 |
| 100 tablet in 1 bottle, plastic | 71335-2202-1 | Bryant Ranch Prepack | 4 August 2023 |
| 100 tablet in 1 bottle | 71335-2674-1 | Bryant Ranch Prepack | 26 June 2025 |
| 30 tablet in 1 bottle | 71335-2674-2 | Bryant Ranch Prepack | 26 June 2025 |
| 60 tablet in 1 bottle | 71335-2674-3 | Bryant Ranch Prepack | 26 June 2025 |
| 1000 tablet in 1 bottle, plastic | 72162-1625-0 | Bryant Ranch Prepack | 5 August 2024 |
| 100 tablet in 1 bottle, plastic | 72162-1625-1 | Bryant Ranch Prepack | 5 August 2024 |
| 30 tablet in 1 bottle, plastic | 72162-1625-3 | Bryant Ranch Prepack | 5 August 2024 |
| 1000 tablet in 1 bottle, plastic | 72162-1625-4 | Bryant Ranch Prepack | 5 August 2024 |
| 500 tablet in 1 bottle, plastic | 72162-1625-5 | Bryant Ranch Prepack | 5 August 2024 |
| 60 tablet in 1 bottle, plastic | 72162-1625-6 | Bryant Ranch Prepack | 5 August 2024 |
| 100 tablet, film coated in 1 bottle | 66993-188-02 | Prasco Laboratories | 29 November 2021 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 48433-090-20 | Safecor Health | 5 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 27 January 1961 | 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
Hydrochlorothiazide and Spironolactone is a fixed-dose combination of an aldosterone antagonist and a thiazide diuretic indicated for edematous conditions for patients with, among other approved uses. It is available as tablets for oral use. MedsAcross supplies Hydrochlorothiazide and 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 Hydrochlorothiazide and 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
- Spironolactone and Hydrochlorothiazide prescribing information (Prasco Laboratories) · U.S. National Library of Medicine, DailyMed
Need Hydrochlorothiazide and Spironolactone 25 mg/25 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.