Medicine
Amoxicillin and Clavulanic acid 400 mg/57 mg per 5 mL powder for oral suspension
Amoxicillin and Clavulanic acid 400 mg/57 mg per 5 mL powder for oral suspension is a generic prescription medicine for oral use, made by 5 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 20° to 25°C (68° to 77°F). Store reconstituted suspension…
Key facts
- Active ingredient (INN)
- Amoxicillin and Clavulanic acid
- 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 4 more
- Manufacturers
- Hikma PharmaceuticalsA-S Medication SolutionsNuCare Pharmaceuticals,IncPreferred PharmaceuticalsProficient Rx
- Origin register
- US FDA, United States
- Storage
- Store dry powder 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
- 1 December 2007
- Identifiers
- RxCUI 617430, 617423DailyMed set ID 4655e0ea-f7d5-4f7c-bf7b-266337bc05b8, 240bcdcb-31d9-40a0-87e1-bd16264a2e20, 483f6fca-e04e-4086-aa44-a361322b811d +2NDC 63187-826, 0143-9982, 50090-0928 +2Application ANDA065191
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 | 0143-9982-01 | Hikma Pharmaceuticals | 1 December 2007 |
| 50 mL in 1 bottle | 0143-9982-50 | Hikma Pharmaceuticals | 1 December 2007 |
| 75 mL in 1 bottle | 0143-9982-75 | Hikma Pharmaceuticals | 1 December 2007 |
| 50 mL in 1 bottle | 50090-0928-0 | A-S Medication Solutions | 28 November 2014 |
| 100 mL in 1 bottle | 68071-1619-1 | NuCare Pharmaceuticals,Inc | 2 November 2017 |
| 100 mL in 1 bottle | 68788-4179-1 | Preferred Pharmaceuticals | 31 July 2026 |
| 100 mL in 1 bottle | 63187-826-00 | Proficient Rx | 1 March 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 |
| 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 Clavulanic acid
Clinical summary
Amoxicillin and Clavulanic acid 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 Clavulanic acid 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 Clavulanic acidFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Amoxicillin and Clavulanate Potassium prescribing information (Hikma Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Amoxicillin and Clavulanic acid 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.