Medicine
Amiloride and Hydrochlorothiazide 5 mg/50 mg tablet
Amiloride and Hydrochlorothiazide 5 mg/50 mg tablet is a generic prescription medicine for oral use, 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 20º to 25ºC (68º to 77ºF).
Key facts
- Active ingredient (INN)
- Amiloride and Hydrochlorothiazide
- Brand
- Sold under the generic name
- Strength
- 5 mg/50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 1000 tablets
- Manufacturer
- Teva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20º to 25ºC (68º to 77ºF).
- 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
- 1 December 1989
- Identifiers
- RxCUI 977883DailyMed set ID 8b2c581a-f955-4a8e-bf85-e768e903fd10NDC 0555-0483Application ANDA071111
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 0555-0483-02 | Teva Pharmaceuticals | 1 December 1989 |
| 1000 tablet in 1 bottle | 0555-0483-05 | Teva Pharmaceuticals | 1 December 1989 |
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 5 October 1981 | 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
Amiloride and Hydrochlorothiazide is a fixed-dose combination of a potassium-sparing diuretic and a thiazide diuretic indicated in those patients with hypertension or with congestive heart failure, among other approved uses. MedsAcross supplies Amiloride and Hydrochlorothiazide 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 Amiloride and HydrochlorothiazideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Amiloride Hydrochloride and Hydrochlorothiazide prescribing information (Teva Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Amiloride and Hydrochlorothiazide 5 mg/50 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.