Medicine
Fosinopril and Hydrochlorothiazide 10 mg/12.5 mg tablet
Fosinopril and Hydrochlorothiazide 10 mg/12.5 mg tablet is a generic prescription medicine for oral use, made by 2 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 moisture by keeping bottle…
Key facts
- Active ingredient (INN)
- Fosinopril and Hydrochlorothiazide
- Brand
- Sold under the generic name
- Strength
- 10 mg/12.5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 30 tablets, 1000 tablets and 1 more
- Manufacturers
- Aurobindo PharmaIndiaCiplaIndia
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from moisture by keeping bottle tightly closed.
- 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
- 9 July 2009
- Identifiers
- RxCUI 857166, 857174DailyMed set ID 4e1ed7da-029e-48d6-a5e4-fc7ac11192fb, 35019655-9a30-4305-a262-936ad0e73071NDC 69097-972, 65862-308Application ANDA090228, ANDA079245
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 | 65862-308-01 | Aurobindo PharmaIndia | 9 July 2009 |
| 30 tablet in 1 bottle | 65862-308-30 | Aurobindo PharmaIndia | 9 July 2009 |
| 1000 tablet in 1 bottle | 65862-308-99 | Aurobindo PharmaIndia | 9 July 2009 |
| 100 tablet in 1 bottle | 69097-972-07 | CiplaIndia | 24 July 2020 |
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 30 November 1994 | 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 Fosinopril and Hydrochlorothiazide
Clinical summary
Fosinopril and Hydrochlorothiazide is a fixed-dose combination of an angiotensin converting enzyme inhibitor and a thiazide diuretic indicated for the treatment of hypertension. It is available as tablets for oral use. MedsAcross supplies Fosinopril 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 Fosinopril 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
- Fosinopril Sodium and Hydrochlorothiazide prescribing information (Aurobindo Pharma) · U.S. National Library of Medicine, DailyMed
Need Fosinopril and Hydrochlorothiazide 10 mg/12.5 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.