Medicine
Amoxicillin and Clavulanate 500 mg/125 mg tablet
Amoxicillin and Clavulanate 500 mg/125 mg tablet is a generic prescription medicine for oral use, made by 21 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
- 500 mg/125 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 500 tablets, 20 tablets, 100 tablets and 63 more
- Manufacturers
- Micro LabsIndiaAurobindo PharmaIndiaNuCare Pharmaceuticals,IncPD-Rx PharmaceuticalsBryant Ranch PrepackProficient RxSandozChartwell RXDevatisTeva Pharmaceuticals21 labelers on the register
- 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
- 15 March 2002
- Identifiers
- RxCUI 617296, 562251, 562508 +4DailyMed set ID f748b118-6d50-487a-824d-1c92ab2028c0, a94cfba3-27ed-46a3-81ef-e9b80187c207, af4c2ea8-73bd-429b-8392-fa20fec6fb3f +35NDC 71335-2735, 76420-507, 50090-0820 +35Application ANDA065064, ANDA091569, ANDA209992 +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
A sample of 40 packs from 21 labelers. The register lists 66 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 500 tablet, film coated in 1 bottle | 65862-502-05 | Aurobindo PharmaIndia | 20 January 2012 |
| 20 tablet, film coated in 1 bottle | 65862-502-20 | Aurobindo PharmaIndia | 20 January 2012 |
| 100 tablet, film coated in 1 bottle | 42571-161-01 | Micro LabsIndia | 1 March 2017 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 42571-161-11 | Micro LabsIndia | 1 March 2017 |
| 20 tablet, film coated in 1 bottle | 42571-161-42 | Micro LabsIndia | 1 March 2017 |
| 100 tablet in 1 bottle | 62135-091-01 | Chartwell RX | 9 October 2026 |
| 20 tablet in 1 bottle | 62135-091-20 | Chartwell RX | 21 July 2026 |
| 20 tablet, film coated in 1 bottle | 73043-007-20 | Devatis | 1 November 2024 |
| 100 tablet, film coated in 1 bottle | 0781-1831-01 | Sandoz | 20 September 2022 |
| 100 tablet, film coated in 1 box, unit-dose | 0781-1831-13 | Sandoz | 15 March 2002 |
| 20 tablet, film coated in 1 bottle | 0781-1831-20 | Sandoz | 15 March 2002 |
| 20 tablet, film coated in 1 bottle | 0093-2274-34 | Teva Pharmaceuticals | 31 October 2002 |
| 20 tablet, film coated in 1 bottle | 68071-2896-2 | NuCare Pharmaceuticals,Inc | 6 December 2022 |
| 3 tablet, film coated in 1 bottle | 68071-2933-3 | NuCare Pharmaceuticals,Inc | 8 February 2023 |
| 30 tablet, film coated in 1 bottle | 68071-3947-3 | NuCare Pharmaceuticals,Inc | 12 January 2026 |
| 20 tablet, film coated in 1 bottle | 68071-4275-2 | NuCare Pharmaceuticals,Inc | 7 February 2018 |
| 3 tablet, film coated in 1 bottle | 68071-4284-3 | NuCare Pharmaceuticals,Inc | 15 February 2018 |
| 4 tablet, film coated in 1 bottle | 68071-4284-4 | NuCare Pharmaceuticals,Inc | 15 February 2018 |
| 21 tablet, film coated in 1 bottle | 68071-4300-1 | NuCare Pharmaceuticals,Inc | 27 February 2018 |
| 30 tablet, film coated in 1 bottle | 68071-4300-3 | NuCare Pharmaceuticals,Inc | 27 February 2018 |
| 14 tablet, film coated in 1 bottle | 68071-4300-4 | NuCare Pharmaceuticals,Inc | 27 February 2018 |
| 6 tablet, film coated in 1 bottle | 68071-4300-6 | NuCare Pharmaceuticals,Inc | 27 February 2018 |
| 20 tablet, film coated in 1 bottle | 71335-2735-1 | Bryant Ranch Prepack | 29 July 2025 |
| 20 tablet, film coated in 1 bottle | 71335-2824-1 | Bryant Ranch Prepack | 23 October 2025 |
| 20 tablet, film coated in 1 bottle | 71335-2999-1 | Bryant Ranch Prepack | 5 November 2025 |
| 20 tablet, film coated in 1 bottle | 72162-2210-2 | Bryant Ranch Prepack | 15 March 2002 |
| 100 tablet, film coated in 1 bottle | 72162-2433-1 | Bryant Ranch Prepack | 16 December 2024 |
| 20 tablet, film coated in 1 bottle | 72162-2433-2 | Bryant Ranch Prepack | 16 December 2024 |
| 6 tablet, film coated in 1 bottle, plastic | 55289-845-06 | PD-Rx Pharmaceuticals | 6 December 2012 |
| 20 tablet, film coated in 1 bottle, plastic | 55289-845-20 | PD-Rx Pharmaceuticals | 6 December 2012 |
| 21 tablet, film coated in 1 bottle, plastic | 55289-845-21 | PD-Rx Pharmaceuticals | 6 December 2012 |
| 28 tablet, film coated in 1 bottle, plastic | 55289-845-28 | PD-Rx Pharmaceuticals | 6 December 2012 |
| 30 tablet, film coated in 1 bottle, plastic | 55289-845-30 | PD-Rx Pharmaceuticals | 6 December 2012 |
| 14 tablet, film coated in 1 bottle, plastic | 72789-418-14 | PD-Rx Pharmaceuticals | 3 July 2024 |
| 21 tablet, film coated in 1 bottle, plastic | 72789-533-21 | PD-Rx Pharmaceuticals | 15 October 2025 |
| 30 tablet, film coated in 1 bottle, plastic | 72789-533-30 | PD-Rx Pharmaceuticals | 20 November 2025 |
| 6 tablet, film coated in 1 bottle | 63187-032-06 | Proficient Rx | 28 December 2020 |
| 20 tablet, film coated in 1 bottle | 63187-032-20 | Proficient Rx | 1 May 2014 |
| 21 tablet, film coated in 1 bottle | 63187-032-21 | Proficient Rx | 28 December 2020 |
| 20 tablet, film coated in 1 bottle | 63187-803-20 | Proficient Rx | 2 January 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 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 500 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.