Medicine
Edarbyclor 40 mg/12.5 mg tablet
Edarbyclor 40 mg/12.5 mg tablet is a prescription medicine containing Azilsartan and Chlorthalidone for oral use, marketed by Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals), 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°-30°C (59°-86°F). Protect…
Key facts
- Active ingredient (INN)
- Azilsartan and Chlorthalidone
- Brand
- Edarbyclor
- Strength
- 40 mg/12.5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets
- Marketing authorisation holder
- Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)
- Manufacturer
- Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15°-30°C (59°-86°F). Protect from moisture and light. Do not repackage, dispense and store in original container.
- 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 February 2013
- Identifiers
- RxCUI 1235144, 1235150, 1235151 +1DailyMed set ID e60f795b-fce3-4361-aa03-f143451689d1NDC 60631-412Application NDA202331
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 |
|---|---|---|---|
| 30 tablet in 1 bottle | 60631-412-30 | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 1 February 2013 |
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 20 December 2011 | 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 Azilsartan and Chlorthalidone
Clinical summary
Azilsartan and Chlorthalidone is a fixed-dose combination of an angiotensin 2 receptor blocker and a thiazide-like diuretic indicated for the treatment of hypertension, to lower blood pressure. It is available as tablets for oral use. MedsAcross supplies Azilsartan and Chlorthalidone 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 Azilsartan and ChlorthalidoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Edarbyclor prescribing information (Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)) · U.S. National Library of Medicine, DailyMed
Need Edarbyclor 40 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.