Medicine
Amoxicillin and Clavulanate 125 mg/31.25 mg per 5 mL powder for oral suspension
Amoxicillin and Clavulanate 125 mg/31.25 mg per 5 mL powder for oral suspension is a generic prescription medicine for oral use, made by 2 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 dry powder at 20º to 25ºC (68º to 77ºF). Reconstituted Oral Suspension…
Key facts
- Active ingredient (INN)
- Amoxicillin and Clavulanate
- Brand
- Sold under the generic name
- Strength
- 125 mg/31.25 mg per 5 mL
- Dosage form
- Powder for oral suspension
- Route
- Oral
- Packs
- 100 mL, 150 mL, 75 mL and 3 more
- Manufacturers
- Aurobindo PharmaIndiaUSAntibiotics
- Origin register
- US FDA, United States
- Storage
- Store dry powder at 20º to 25ºC (68º to 77ºF). Reconstituted Oral Suspension Store reconstituted amoxicillin and clavulanate potassium for oral suspension in the original container under refrigeration. A slight color change during storage is normal.
- 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
- 19 April 2019
- Identifiers
- RxCUI 617302, 617322, 562508DailyMed set ID 3ae0c95f-7ffa-4317-9fea-4d07b86bee72, c4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f3NDC 59651-025, 81964-212Application ANDA209371, NDA050575
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 | 59651-025-01 | Aurobindo PharmaIndia | 19 April 2019 |
| 150 mL in 1 bottle | 59651-025-55 | Aurobindo PharmaIndia | 19 April 2019 |
| 75 mL in 1 bottle | 59651-025-75 | Aurobindo PharmaIndia | 19 April 2019 |
| 75 mL in 1 bottle | 81964-212-01 | USAntibiotics | 5 December 2022 |
| 100 mL in 1 bottle | 81964-212-03 | USAntibiotics | 5 December 2022 |
| 150 mL in 1 bottle | 81964-212-05 | USAntibiotics | 5 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
Alternatives
Other makers and brands of Amoxicillin and Clavulanate 125 mg/31.25 mg per 5 mL powder for oral suspension.
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 125 mg/31.25 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.