Medicine
Metolazone 5 mg tablet
Metolazone 5 mg tablet is a generic prescription medicine for oral use, made by 17 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). Protect from light.
Key facts
- Active ingredient (INN)
- Metolazone
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 1000 tablets, 100 blister pack and 30 more
- Manufacturers
- Alembic PharmaceuticalsIndiaUnichem LaboratoriesIndiaBryant Ranch PrepackMethod PharmaceuticalsAarkish Pharmaceuticals NJAmici PharmaMarlex PharmaceuticalsSandozAdvagen PharmaAmerican Health Packaging
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C03BA08 Metolazone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 19 December 2003
- Identifiers
- RxCUI 311671, 197978, 197979DailyMed set ID 08cb093a-b8ec-40d9-b292-2513b488d14c, 0f189f26-be06-4030-aebc-d0557b6475fb, efa8795e-2c89-4519-b49f-13146fb9ded1 +20NDC 72162-1050, 46708-533, 48433-069 +21Application ANDA076466, ANDA213251, ANDA076698 +5
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 | 46708-533-31 | Alembic PharmaceuticalsIndia | 2 December 2020 |
| 1000 tablet in 1 bottle | 46708-533-91 | Alembic PharmaceuticalsIndia | 2 December 2020 |
| 100 tablet in 1 bottle | 62332-533-31 | Alembic PharmaceuticalsIndia | 2 December 2020 |
| 1000 tablet in 1 bottle | 62332-533-91 | Alembic PharmaceuticalsIndia | 2 December 2020 |
| 100 tablet in 1 bottle | 76385-137-01 | Unichem LaboratoriesIndia | 30 March 2021 |
| 100 tablet in 1 bottle | 58657-741-01 | Method Pharmaceuticals | 15 June 2024 |
| 1000 tablet in 1 bottle | 58657-741-10 | Method Pharmaceuticals | 15 June 2024 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 58657-941-01 | Method Pharmaceuticals | 28 January 2026 |
| 100 tablet in 1 bottle | 81005-125-01 | Aarkish Pharmaceuticals NJ | 15 August 2023 |
| 1000 tablet in 1 bottle | 81005-125-10 | Aarkish Pharmaceuticals NJ | 15 August 2023 |
| 100 tablet in 1 bottle | 72888-053-01 | Advagen Pharma | 20 August 2021 |
| 100 tablet in 1 bottle | 69292-564-01 | Amici Pharma | 15 May 2021 |
| 1000 tablet in 1 bottle | 69292-564-10 | Amici Pharma | 15 May 2021 |
| 100 tablet in 1 bottle | 50742-350-01 | Ingenus Pharmaceuticals | 24 January 2023 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 51079-024-20 | Mylan Institutional | 1 February 2005 |
| 100 tablet in 1 bottle, plastic | 0378-6173-01 | Mylan Pharmaceuticals | 19 October 2004 |
| 100 tablet in 1 bottle | 0185-0055-01 | Sandoz | 19 December 2003 |
| 1000 tablet in 1 bottle | 0185-0055-10 | Sandoz | 19 December 2003 |
| 30 tablet in 1 bottle | 63629-7875-1 | Bryant Ranch Prepack | 18 December 2018 |
| 90 tablet in 1 bottle | 63629-7875-2 | Bryant Ranch Prepack | 29 April 2022 |
| 100 tablet in 1 bottle | 63629-8733-1 | Bryant Ranch Prepack | 19 August 2021 |
| 30 tablet in 1 bottle | 71335-1944-1 | Bryant Ranch Prepack | 21 September 2021 |
| 90 tablet in 1 bottle | 71335-1944-2 | Bryant Ranch Prepack | 21 September 2021 |
| 100 tablet in 1 bottle | 71335-2850-1 | Bryant Ranch Prepack | 21 October 2025 |
| 100 tablet in 1 bottle | 72162-1050-1 | Bryant Ranch Prepack | 1 August 2024 |
| 100 tablet in 1 bottle | 72162-2390-1 | Bryant Ranch Prepack | 20 July 2026 |
| 100 blister pack in 1 box, unit-dose / 1 tablet in 1 blister pack | 60687-635-01 | American Health Packaging | 16 February 2022 |
| 9000 tablet in 1 bottle, plastic | 43353-931-09 | Aphena Pharma Solutions - Tennessee | 24 April 2014 |
| 100 tablet in 1 bottle | 51407-432-01 | Golden State Medical Supply | 29 June 2021 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 0904-7521-61 | Major Pharmaceuticals | 20 November 2025 |
| 100 tablet in 1 bottle | 10135-766-01 | Marlex Pharmaceuticals | 1 December 2022 |
| 1000 tablet in 1 bottle | 10135-766-10 | Marlex Pharmaceuticals | 1 December 2022 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 48433-069-20 | Safecor Health | 19 February 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 November 1973 | 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 Metolazone
Clinical summary
Metolazone is a thiazide-like diuretic indicated for the treatment of salt and water retention including · edema accompanying congestive heart failure, · edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. MedsAcross supplies Metolazone 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 MetolazoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Metolazone prescribing information (Amici Pharma) · U.S. National Library of Medicine, DailyMed
Need Metolazone 5 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.