Medicine
Acebutolol 400 mg capsule
Acebutolol 400 mg capsule 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 20° to 25°C (68° to 77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Acebutolol
- Brand
- Sold under the generic name
- Strength
- 400 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 30 capsules, 100 capsules, 500 capsules and 5 more
- Manufacturers
- Amneal PharmaceuticalsAmneal Pharmaceuticals of New YorkANI PharmaceuticalsGolden State Medical Supply
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C07AB04 Acebutolol
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 18 October 1995
- Identifiers
- RxCUI 998685, 998689DailyMed set ID 28f8c26c-a1e1-4485-a45f-05c82f7a34b5, f037a079-fde6-3588-e053-2995a90a6621, fe2cd5c0-ee16-4bcb-ad92-3755881dbe79 +1NDC 65162-670, 51407-667, 53746-670 +1Application ANDA075047, ANDA074007
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 |
|---|---|---|---|
| 30 capsule in 1 bottle | 65162-670-03 | Amneal Pharmaceuticals | 1 December 2009 |
| 100 capsule in 1 bottle | 65162-670-10 | Amneal Pharmaceuticals | 1 December 2009 |
| 500 capsule in 1 bottle | 65162-670-50 | Amneal Pharmaceuticals | 1 December 2009 |
| 100 capsule in 1 bottle | 53746-670-01 | Amneal Pharmaceuticals of New York | 1 December 2009 |
| 500 capsule in 1 bottle | 53746-670-05 | Amneal Pharmaceuticals of New York | 1 December 2009 |
| 30 capsule in 1 bottle | 53746-670-30 | Amneal Pharmaceuticals of New York | 1 December 2009 |
| 100 capsule in 1 bottle | 62559-256-01 | ANI Pharmaceuticals | 25 July 2022 |
| 100 capsule in 1 bottle | 51407-667-01 | Golden State Medical Supply | 1 August 2022 |
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 28 December 1984 | 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 Acebutolol
Clinical summary
Acebutolol is a beta-adrenergic blocker indicated for the management of hypertension in adults. It is available as capsules for oral use. MedsAcross supplies Acebutolol 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 AcebutololFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Acebutolol Hydrochloride prescribing information (ANI Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Acebutolol 400 mg capsule 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.