Medicine
Amoxicillin and Clavulanate 562.5 mg/437.5 mg/62.5 mg extended-release tablet
Amoxicillin and Clavulanate 562.5 mg/437.5 mg/62.5 mg extended-release tablet is a generic prescription medicine for oral use, made by 3 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 tablets at 20°C to 25°C (68°F to 77°F).
Key facts
- Active ingredient (INN)
- Amoxicillin and Clavulanate
- Brand
- Sold under the generic name
- Strength
- 562.5 mg/437.5 mg/62.5 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 40 tablets, 28 tablets and 2 more
- Manufacturers
- SandozUSAntibioticsSportpharm
- Origin register
- US FDA, United States
- Storage
- Store tablets at 20°C to 25°C (68°F to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.10Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 21 April 2010
- Identifiers
- RxCUI 617995DailyMed set ID cd7d2c0c-bf58-457a-b3d1-bb4c167cd127, 45c60b69-1b65-01ed-e063-6294a90a57be, e41387c8-2c74-4990-831f-64dc921ee138NDC 85766-123, 81964-220, 0781-1943Application ANDA090227, NDA050785
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 |
|---|---|---|---|
| 40 tablet, multilayer, extended release in 1 bottle | 0781-1943-39 | Sandoz | 21 April 2010 |
| 28 tablet, multilayer, extended release in 1 bottle | 0781-1943-82 | Sandoz | 21 April 2010 |
| 28 tablet, film coated, extended release in 1 bottle | 81964-220-28 | USAntibiotics | 15 December 2025 |
| 40 tablet, film coated, extended release in 1 bottle | 81964-220-40 | USAntibiotics | 15 December 2025 |
| 28 tablet, multilayer, extended release in 1 bottle | 85766-123-28 | Sportpharm | 6 November 2025 |
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 6 August 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 Amoxicillin and Clavulanate
Clinical summary
Amoxicillin and Clavulanate is a fixed-dose combination of a penicillin-class antibacterial and a beta lactamase inhibitor indicated for the treatment of infections in adults and pediatric patients, among other approved uses. MedsAcross supplies Amoxicillin and Clavulanate 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 Amoxicillin and ClavulanateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Augmentin prescribing information (Allegis Holdings) · U.S. National Library of Medicine, DailyMed
Need Amoxicillin and Clavulanate 562.5 mg/437.5 mg/62.5 mg extended-release 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.