Medicine
Amoxicillin 125 mg/5 mL powder for oral suspension
Amoxicillin 125 mg/5 mL powder for oral suspension is a generic prescription medicine for oral use, made by 9 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 unreconstituted powder for oral suspension at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Amoxicillin
- Brand
- Sold under the generic name
- Strength
- 125 mg/5 mL
- Dosage form
- Powder for oral suspension
- Route
- Oral
- Packs
- 100 mL, 150 mL, 80 mL and 26 more
- Manufacturers
- Aurobindo PharmaIndiaChartwell RXA-S Medication SolutionsHawaii RepackHikma PharmaceuticalsNuCare Pharmaceuticals,IncSandozPreferred PharmaceuticalsProficient Rx
- Origin register
- US FDA, United States
- Storage
- Store unreconstituted powder for oral suspension 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
- ATC code
- J01CA04 Amoxicillin
- HS code (indicative)
- 3004.10Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 8 December 1978
- Identifiers
- RxCUI 313797, 239191, 308189 +7DailyMed set ID 5f8b3c58-ed9f-84a2-e053-2a91aa0ac8cf, 669a243e-249d-4ccb-9693-66de073e53bb, b07b5ac4-253e-4c83-91c3-3fdc46e91a0f +14NDC 68071-1760, 85534-0070, 62135-109 +14Application ANDA065322, ANDA065387, ANDA061931 +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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 mL in 1 bottle | 65862-706-01 | Aurobindo PharmaIndia | 15 September 2014 |
| 150 mL in 1 bottle | 65862-706-55 | Aurobindo PharmaIndia | 15 September 2014 |
| 80 mL in 1 bottle | 65862-706-80 | Aurobindo PharmaIndia | 15 September 2014 |
| 100 mL in 1 bottle | 62135-109-01 | Chartwell RX | 2 September 2026 |
| 150 mL in 1 bottle | 62135-109-51 | Chartwell RX | 2 September 2026 |
| 80 mL in 1 bottle | 62135-109-80 | Chartwell RX | 2 September 2026 |
| 150 mL in 1 bottle | 62135-776-38 | Chartwell RX | 15 December 2023 |
| 100 mL in 1 bottle | 62135-776-42 | Chartwell RX | 15 December 2023 |
| 80 mL in 1 bottle | 62135-776-68 | Chartwell RX | 15 December 2023 |
| 100 mL in 1 bottle | 0143-9888-01 | Hikma Pharmaceuticals | 19 June 2006 |
| 150 mL in 1 bottle | 0143-9888-15 | Hikma Pharmaceuticals | 19 June 2006 |
| 80 mL in 1 bottle | 0143-9888-80 | Hikma Pharmaceuticals | 19 June 2006 |
| 100 mL in 1 bottle | 0781-6039-46 | Sandoz | 26 March 2007 |
| 150 mL in 1 bottle | 0781-6039-55 | Sandoz | 26 March 2007 |
| 80 mL in 1 bottle | 0781-6039-58 | Sandoz | 26 March 2007 |
| 100 mL in 1 bottle | 50090-0404-0 | A-S Medication Solutions | 29 June 2016 |
| 150 mL in 1 bottle | 50090-0406-0 | A-S Medication Solutions | 29 June 2016 |
| 150 mL in 1 bottle | 50090-6056-0 | A-S Medication Solutions | 25 August 2022 |
| 150 mL in 1 bottle | 50090-6791-0 | A-S Medication Solutions | 1 November 2023 |
| 100 mL in 1 bottle | 68071-1760-1 | NuCare Pharmaceuticals,Inc | 4 December 2017 |
| 150 mL in 1 bottle | 68071-1761-5 | NuCare Pharmaceuticals,Inc | 25 October 2017 |
| 150 mL in 1 bottle | 68071-4969-5 | NuCare Pharmaceuticals,Inc | 15 July 2019 |
| 100 mL in 1 bottle | 68788-4024-1 | Preferred Pharmaceuticals | 5 September 2025 |
| 150 mL in 1 bottle | 68788-9949-1 | Preferred Pharmaceuticals | 12 January 2012 |
| 150 mL in 1 bottle | 63187-295-15 | Proficient Rx | 2 February 2015 |
| 150 mL in 1 bottle | 71205-266-15 | Proficient Rx | 1 May 2019 |
| 80 mL in 1 bottle | 85534-0070-0 | Hawaii Repack | 3 July 2026 |
| 100 mL in 1 bottle | 85534-0070-1 | Hawaii Repack | 3 July 2026 |
| 150 mL in 1 bottle | 85534-0070-2 | Hawaii Repack | 3 July 2026 |
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
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 125 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.