Medicine
Candesartan cilexetil and Hydrochlorothiazide 16 mg/12.5 mg tablet
Candesartan cilexetil and Hydrochlorothiazide 16 mg/12.5 mg tablet is a generic prescription medicine for oral use, made by 5 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), excursions permitted at 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Candesartan cilexetil and Hydrochlorothiazide
- Brand
- Sold under the generic name
- Strength
- 16 mg/12.5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 90 tablets, 10 blister pack, 500 tablets and 10 more
- Manufacturers
- Zydus LifesciencesIndiaMacleods PharmaceuticalsIndiaSolco HealthcareANI PharmaceuticalsMylan Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted at 15° to 30°C (59° to 86°F).
- 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
- 4 December 2012
- Identifiers
- RxCUI 578325, 578330, 802749DailyMed set ID bd8d318d-167a-4b26-935d-265dde3193de, 543b9806-ccfa-4144-a2a2-d0e35eaceeee, cb328bc1-5738-4620-b2b3-442e98388a86 +2NDC 62559-660, 43547-459, 70771-1325 +2Application NDA021093, ANDA207455, ANDA203466 +2
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 |
|---|---|---|---|
| 90 tablet in 1 bottle | 33342-131-10 | Macleods PharmaceuticalsIndia | 7 March 2015 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 33342-131-12 | Macleods PharmaceuticalsIndia | 7 March 2015 |
| 500 tablet in 1 bottle | 33342-131-15 | Macleods PharmaceuticalsIndia | 7 March 2015 |
| 300 tablet in 1 bottle | 33342-131-51 | Macleods PharmaceuticalsIndia | 7 March 2015 |
| 1000 tablet in 1 bottle | 70771-1325-0 | Zydus LifesciencesIndia | 14 April 2018 |
| 100 tablet in 1 bottle | 70771-1325-1 | Zydus LifesciencesIndia | 14 April 2018 |
| 30 tablet in 1 bottle | 70771-1325-3 | Zydus LifesciencesIndia | 14 April 2018 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 70771-1325-4 | Zydus LifesciencesIndia | 14 April 2018 |
| 90 tablet in 1 bottle | 70771-1325-9 | Zydus LifesciencesIndia | 14 April 2018 |
| 90 tablet in 1 bottle | 62559-660-90 | ANI Pharmaceuticals | 26 September 2018 |
| 90 tablet in 1 bottle, plastic | 0378-3001-77 | Mylan Pharmaceuticals | 4 December 2012 |
| 90 tablet in 1 bottle | 43547-459-09 | Solco Healthcare | 20 November 2017 |
| 500 tablet in 1 bottle | 43547-459-50 | Solco Healthcare | 20 November 2017 |
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 September 2000 | 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
Alternatives
Other makers and brands of Candesartan cilexetil and Hydrochlorothiazide 16 mg/12.5 mg tablet.
Other strengths and forms of Candesartan cilexetil and Hydrochlorothiazide
Clinical summary
Candesartan cilexetil and Hydrochlorothiazide is a fixed-dose combination of an angiotensin 2 receptor blocker and a thiazide diuretic indicated for the treatment of hypertension, to lower blood pressure. MedsAcross supplies Candesartan cilexetil 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 Candesartan cilexetil 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
- Candesartan Cilexetil and Hydrochlorothiazide prescribing information (ANI Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Candesartan cilexetil and Hydrochlorothiazide 16 mg/12.5 mg tablet for your hospital or patient?
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