Medicine
Amoxicillin 400 mg/5 mL powder for oral suspension
Amoxicillin 400 mg/5 mL powder for oral suspension is a generic prescription medicine for oral use, made by 16 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), excursions permitted to 15° to…
Key facts
- Active ingredient (INN)
- Amoxicillin
- Brand
- Sold under the generic name
- Strength
- 400 mg/5 mL
- Dosage form
- Powder for oral suspension
- Route
- Oral
- Packs
- 100 mL, 50 mL, 75 mL and 53 more
- Manufacturers
- Aurobindo PharmaIndiaA-S Medication SolutionsProficient RxNuCare Pharmaceuticals,IncChartwell RXHikma PharmaceuticalsRising Pharma HoldingsSandozTeva PharmaceuticalsUSAntibiotics16 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store dry powder at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J01CA04 Amoxicillin
- HS code (indicative)
- 3004.10Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 26 February 2003
- Identifiers
- RxCUI 308189, 617296, 239191 +7DailyMed set ID cedde8f5-aadd-53de-e053-2995a90aab16, 06e5c07d-d95c-4955-8d35-a4703ca2359e, e40f3e20-facf-46f4-89c7-3593bc27d0fc +32NDC 72189-285, 81964-207, 63187-335 +32Application ANDA065334, NDA050760, ANDA065325 +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
A sample of 40 packs from 16 labelers. The register lists 56 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 mL in 1 bottle | 65862-071-01 | Aurobindo PharmaIndia | 28 December 2006 |
| 50 mL in 1 bottle | 65862-071-50 | Aurobindo PharmaIndia | 28 December 2006 |
| 75 mL in 1 bottle | 65862-071-75 | Aurobindo PharmaIndia | 28 December 2006 |
| 100 mL in 1 bottle | 62135-090-01 | Chartwell RX | 16 July 2026 |
| 50 mL in 1 bottle | 62135-090-50 | Chartwell RX | 16 July 2026 |
| 75 mL in 1 bottle | 62135-090-75 | Chartwell RX | 16 July 2026 |
| 100 mL in 1 bottle | 62135-815-42 | Chartwell RX | 25 June 2024 |
| 100 mL in 1 bottle | 0143-9887-01 | Hikma Pharmaceuticals | 19 June 2006 |
| 50 mL in 1 bottle | 0143-9887-50 | Hikma Pharmaceuticals | 19 June 2006 |
| 75 mL in 1 bottle | 0143-9887-75 | Hikma Pharmaceuticals | 19 June 2006 |
| 100 mL in 1 bottle | 57237-033-01 | Rising Pharma Holdings | 28 December 2006 |
| 50 mL in 1 bottle | 57237-033-50 | Rising Pharma Holdings | 28 December 2006 |
| 75 mL in 1 bottle | 57237-033-75 | Rising Pharma Holdings | 28 December 2006 |
| 100 mL in 1 bottle | 0781-6157-46 | Sandoz | 26 March 2007 |
| 50 mL in 1 bottle | 0781-6157-52 | Sandoz | 26 March 2007 |
| 75 mL in 1 bottle | 0781-6157-57 | Sandoz | 26 March 2007 |
| 100 mL in 1 bottle | 0093-4161-73 | Teva Pharmaceuticals | 26 February 2003 |
| 50 mL in 1 bottle | 0093-4161-76 | Teva Pharmaceuticals | 1 July 2003 |
| 75 mL in 1 bottle | 0093-4161-78 | Teva Pharmaceuticals | 1 July 2003 |
| 50 mL in 1 bottle | 81964-207-50 | USAntibiotics | 1 April 2024 |
| 75 mL in 1 bottle | 81964-207-51 | USAntibiotics | 1 April 2024 |
| 100 mL in 1 bottle | 81964-207-52 | USAntibiotics | 1 April 2024 |
| 100 mL in 1 bottle | 50090-0858-0 | A-S Medication Solutions | 28 November 2014 |
| 75 mL in 1 bottle | 50090-1086-0 | A-S Medication Solutions | 28 November 2014 |
| 50 mL in 1 bottle | 50090-1347-0 | A-S Medication Solutions | 28 November 2014 |
| 100 mL in 1 bottle | 50090-6323-0 | A-S Medication Solutions | 12 January 2023 |
| 75 mL in 1 bottle | 50090-6355-0 | A-S Medication Solutions | 2 February 2023 |
| 50 mL in 1 bottle | 50090-6680-0 | A-S Medication Solutions | 8 September 2023 |
| 100 mL in 1 bottle | 68071-1675-1 | NuCare Pharmaceuticals,Inc | 20 September 2017 |
| 100 mL in 1 bottle | 68071-3925-1 | NuCare Pharmaceuticals | 4 December 2025 |
| 75 mL in 1 bottle | 68071-4796-5 | NuCare Pharmaceuticals,Inc | 8 March 2019 |
| 100 mL in 1 bottle | 68071-5109-1 | NuCare Pharmaceuticals,Inc | 18 November 2019 |
| 75 mL in 1 bottle | 68071-5127-5 | NuCare Pharmaceuticals,Inc | 11 December 2019 |
| 100 mL in 1 bottle | 63187-262-00 | Proficient Rx | 2 February 2015 |
| 50 mL in 1 bottle | 63187-262-50 | Proficient Rx | 11 January 2024 |
| 100 mL in 1 bottle | 63187-335-00 | Proficient Rx | 1 January 2019 |
| 100 mL in 1 bottle | 71205-177-00 | Proficient Rx | 1 December 2018 |
| 100 mL in 1 bottle | 71205-422-00 | Proficient Rx | 12 March 2020 |
| 100 mL in 1 bottle | 71205-436-00 | Proficient Rx | 3 September 2020 |
| 100 mL in 1 bottle | 68788-8325-1 | Preferred Pharmaceuticals | 19 January 2023 |
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 18 January 1974 | 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 400 mg/5 mL powder for oral suspension.
Other strengths and forms of Amoxicillin
Clinical summary
Amoxicillin is a penicillin-class antibacterial indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species, among other approved uses. It is available as capsules, powder for oral suspension and tablets. MedsAcross supplies Amoxicillin 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 AmoxicillinFor 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 prescribing information (USAntibiotics) · U.S. National Library of Medicine, DailyMed
Need Amoxicillin 400 mg/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.