Medicine
Amiloride 5 mg tablet
Amiloride 5 mg tablet is a generic prescription medicine for oral use, made by 4 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 controlled room temperature 15° to 30°C (59° to 86°F).
Key facts
- Active ingredient (INN)
- Amiloride
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 1000 tablets, 10 blister pack and 2 more
- Manufacturers
- Par HealthKesin PharmaPadagisSigmapharm Laboratories
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature 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
- C03DB01 Amiloride
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 22 January 1986
- Identifiers
- RxCUI 977880DailyMed set ID e0cc2d44-436a-47e8-a890-589882fff4c4, 5eedadbd-9be9-b920-e063-6394a90afa68, 2b70cf0c-45be-428f-b396-5001ed4e30fc +1NDC 49884-117, 81033-043, 0574-0292 +1Application ANDA070346, NDA018200, ANDA079133
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 | 0574-0292-01 | Padagis | 6 April 2009 |
| 100 tablet in 1 bottle | 49884-117-01 | Par Health | 12 May 1986 |
| 1000 tablet in 1 bottle | 49884-117-10 | Par Health | 12 May 1986 |
| 100 tablet in 1 bottle | 42794-005-02 | Sigmapharm Laboratories | 14 June 2021 |
| 10 blister pack in 1 carton / 100 tablet in 1 blister pack | 81033-043-11 | Kesin Pharma | 11 November 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 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 is a potassium-sparing diuretic indicated as adjunctive treatment with thiazide diuretics or other kaliuretic-diuretic agents in congestive heart failure or hypertension to a. It is available as tablets for oral use. MedsAcross supplies Amiloride 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 AmilorideFor 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 prescribing information (Padagis) · U.S. National Library of Medicine, DailyMed
Need Amiloride 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.