Medicine
Amoxicillin and Clavulanate 400 mg/57 mg per 5 mL powder for oral suspension
Amoxicillin and Clavulanate 400 mg/57 mg per 5 mL powder for oral suspension is a generic prescription medicine for oral use, made by 13 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). Store reconstituted suspension under…
Key facts
- Active ingredient (INN)
- Amoxicillin and Clavulanate
- Brand
- Sold under the generic name
- Strength
- 400 mg/57 mg per 5 mL
- Dosage form
- Powder for oral suspension
- Route
- Oral
- Packs
- 100 mL, 50 mL, 75 mL and 31 more
- Manufacturers
- Aurobindo PharmaIndiaA-S Medication SolutionsProficient RxAsclemedChartwell RXDevatisHawaii RepackNorthStar RxSandozNuCare Pharmaceuticals,Inc
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Store reconstituted suspension under refrigeration.
- 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
- 22 October 1990
- Identifiers
- RxCUI 562508, 617296, 617309 +4DailyMed set ID f10634cb-6505-43f1-9b70-314c58673016, 963e7bea-ff5d-420a-9cb2-e4aefb534b33, 2718248d-d948-466e-959b-1a972519f108 +16NDC 62135-094, 0093-2279, 50090-5873 +16Application ANDA065089, ANDA201090, ANDA065098 +3
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 |
|---|---|---|---|
| 100 mL in 1 bottle | 65862-534-01 | Aurobindo PharmaIndia | 20 December 2011 |
| 50 mL in 1 bottle | 65862-534-50 | Aurobindo PharmaIndia | 20 December 2011 |
| 75 mL in 1 bottle | 65862-534-75 | Aurobindo PharmaIndia | 20 December 2011 |
| 100 mL in 1 bottle | 62135-094-01 | Chartwell RX | 21 July 2026 |
| 50 mL in 1 bottle | 62135-094-50 | Chartwell RX | 21 July 2026 |
| 75 mL in 1 bottle | 62135-094-75 | Chartwell RX | 21 July 2026 |
| 50 mL in 1 bottle | 73043-009-01 | Devatis | 1 November 2024 |
| 75 mL in 1 bottle | 73043-009-02 | Devatis | 1 November 2024 |
| 100 mL in 1 bottle | 73043-009-03 | Devatis | 1 November 2024 |
| 100 mL in 1 bottle | 0781-6104-46 | Sandoz | 5 June 2002 |
| 50 mL in 1 bottle | 0781-6104-52 | Sandoz | 18 December 2023 |
| 75 mL in 1 bottle | 0781-6104-57 | Sandoz | 18 December 2023 |
| 100 mL in 1 bottle | 0093-2279-73 | Teva Pharmaceuticals | 13 January 2005 |
| 100 mL in 1 bottle | 50090-3309-0 | A-S Medication Solutions | 20 December 2017 |
| 100 mL in 1 bottle | 50090-5873-0 | A-S Medication Solutions | 10 December 2021 |
| 50 mL in 1 bottle | 50090-6381-0 | A-S Medication Solutions | 27 February 2023 |
| 50 mL in 1 bottle | 50090-6694-0 | A-S Medication Solutions | 18 September 2023 |
| 100 mL in 1 bottle | 63187-320-00 | Proficient Rx | 2 February 2015 |
| 100 mL in 1 bottle | 63187-770-00 | Proficient Rx | 1 November 2016 |
| 100 mL in 1 bottle | 71205-462-00 | Proficient Rx | 7 July 2020 |
| 50 mL in 1 bottle | 71205-462-50 | Proficient Rx | 4 September 2024 |
| 100 mL in 1 bottle | 68071-2227-1 | NuCare Pharmaceuticals,Inc | 31 July 2020 |
| 100 mL in 1 bottle | 68071-2518-1 | NuCare Pharmaceuticals,Inc | 25 August 2021 |
| 100 mL in 1 bottle | 76420-864-01 | Asclemed | 24 October 2024 |
| 50 mL in 1 bottle | 76420-864-50 | Asclemed | 24 October 2024 |
| 75 mL in 1 bottle | 76420-864-75 | Asclemed | 24 October 2024 |
| 5 mL in 1 bottle | 72189-367-32 | Direct_Rx | 8 August 2022 |
| 50 mL in 1 bottle | 85534-0041-0 | Hawaii Repack | 13 July 2026 |
| 75 mL in 1 bottle | 85534-0041-1 | Hawaii Repack | 13 July 2026 |
| 100 mL in 1 bottle | 85534-0041-2 | Hawaii Repack | 13 July 2026 |
| 50 mL in 1 bottle | 16714-293-01 | NorthStar Rx | 20 December 2011 |
| 75 mL in 1 bottle | 16714-293-02 | NorthStar Rx | 20 December 2011 |
| 100 mL in 1 bottle | 16714-293-03 | NorthStar Rx | 20 December 2011 |
| 100 mL in 1 bottle | 68788-8318-1 | Preferred Pharmaceuticals | 23 December 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 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 400 mg/57 mg per 5 mL powder for oral suspension 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.