Medicine
Amoxicillin and Clavulanate 250 mg/125 mg tablet
Amoxicillin and Clavulanate 250 mg/125 mg tablet is a generic prescription medicine for oral use, made by 8 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).
Key facts
- Active ingredient (INN)
- Amoxicillin and Clavulanate
- Brand
- Sold under the generic name
- Strength
- 250 mg/125 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 500 tablets, 30 tablets, 100 tablets and 9 more
- Manufacturers
- Micro LabsIndiaAurobindo PharmaIndiaBryant Ranch PrepackAmerican Health PackagingAsclemedNorthStar RxSandozSportpharm
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° 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
- 23 August 2005
- Identifiers
- RxCUI 562251, 562508, 617296 +2DailyMed set ID b9bcd4a4-d4ae-4460-9eff-e80439fafd6f, 4966a3f2-eed2-4081-ba88-310a3d1964b4, ffb158a1-83ba-4100-9221-175aa986dc3e +6NDC 72162-2435, 60687-781, 65862-501 +6Application ANDA205707, ANDA091569, ANDA065189
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 |
|---|---|---|---|
| 500 tablet, film coated in 1 bottle | 65862-501-05 | Aurobindo PharmaIndia | 20 January 2012 |
| 30 tablet, film coated in 1 bottle | 65862-501-30 | Aurobindo PharmaIndia | 20 January 2012 |
| 100 tablet, film coated in 1 bottle | 42571-160-01 | Micro LabsIndia | 1 March 2017 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 42571-160-11 | Micro LabsIndia | 1 March 2017 |
| 30 tablet, film coated in 1 bottle | 42571-160-30 | Micro LabsIndia | 1 March 2017 |
| 30 tablet, film coated in 1 bottle | 0781-1874-31 | Sandoz | 23 August 2005 |
| 30 tablet, film coated in 1 bottle | 71335-2896-1 | Bryant Ranch Prepack | 23 October 2025 |
| 30 tablet, film coated in 1 bottle | 72162-2435-3 | Bryant Ranch Prepack | 16 December 2024 |
| 20 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack | 60687-781-94 | American Health Packaging | 26 July 2024 |
| 30 tablet, film coated in 1 bottle | 76420-503-30 | Asclemed | 15 October 2019 |
| 30 tablet, film coated in 1 bottle | 16714-295-01 | NorthStar Rx | 20 January 2012 |
| 30 tablet, film coated in 1 bottle | 85766-080-30 | Sportpharm | 15 October 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 250 mg/125 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.