Medicine
Hydrochlorothiazide and Metoprolol 50 mg/100 mg tablet
Hydrochlorothiazide and Metoprolol 50 mg/100 mg tablet is a generic prescription medicine for oral use, made by 3 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 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F)…
Key facts
- Active ingredient (INN)
- Hydrochlorothiazide and Metoprolol
- Brand
- Sold under the generic name
- Strength
- 50 mg/100 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 30 tablets, 500 tablets and 8 more
- Manufacturers
- Alembic PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaMylan Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). Protect from moisture.
- 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
- 20 August 2004
- Identifiers
- RxCUI 866479, 866482, 866491DailyMed set ID 2b77f66f-6891-4977-be8f-7955473d2f92, b6cf0f43-8dc3-4535-b651-daf1f9e0336c, 538ea34a-1ac3-48c8-b841-43be09285e12 +1NDC 62332-117, 0378-0445, 46708-117 +1Application ANDA202870, ANDA076792, ANDA090654
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 | 46708-117-10 | Alembic PharmaceuticalsIndia | 17 September 2013 |
| 30 tablet in 1 bottle | 46708-117-30 | Alembic PharmaceuticalsIndia | 17 September 2013 |
| 500 tablet in 1 bottle | 46708-117-50 | Alembic PharmaceuticalsIndia | 17 September 2013 |
| 30 tablet in 1 bottle | 62332-117-30 | Alembic PharmaceuticalsIndia | 15 October 2015 |
| 100 tablet in 1 bottle | 62332-117-31 | Alembic PharmaceuticalsIndia | 15 October 2015 |
| 500 tablet in 1 bottle | 62332-117-71 | Alembic PharmaceuticalsIndia | 15 October 2015 |
| 100 tablet in 1 bottle | 62756-369-08 | Sun Pharmaceutical IndustriesIndia | 1 April 2022 |
| 1000 tablet in 1 bottle | 62756-369-18 | Sun Pharmaceutical IndustriesIndia | 1 April 2022 |
| 30 tablet in 1 bottle | 62756-369-83 | Sun Pharmaceutical IndustriesIndia | 1 April 2022 |
| 100 tablet in 1 bottle | 62756-369-88 | Sun Pharmaceutical IndustriesIndia | 1 April 2022 |
| 100 tablet in 1 bottle, plastic | 0378-0445-01 | Mylan Pharmaceuticals | 20 August 2004 |
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 31 December 1984 | 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 Hydrochlorothiazide and Metoprolol
Clinical summary
Hydrochlorothiazide and Metoprolol is a fixed-dose combination of a thiazide diuretic and a beta-adrenergic blocker indicated for the treatment of hypertension, to lower blood pressure, among other approved uses. MedsAcross supplies Hydrochlorothiazide and Metoprolol 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 MetoprololFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Metoprolol Tartrate and Hydrochlorothiazide prescribing information (Mylan Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Hydrochlorothiazide and Metoprolol 50 mg/100 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.