Medicine
Amoxil 400 mg/5 mL powder for oral suspension
Amoxil 400 mg/5 mL powder for oral suspension is a prescription medicine containing Amoxicillin for oral use, marketed by DirectRx, 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 ) Dispense in a tight, light-resistant…
Key facts
- Active ingredient (INN)
- Amoxicillin
- Brand
- Amoxil
- Strength
- 400 mg/5 mL
- Dosage form
- Powder for oral suspension
- Route
- Oral
- Packs
- 100 mL
- Marketing authorisation holder
- DirectRx
- Manufacturer
- DirectRx
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F ) Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
- 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
- 21 October 2022
- Identifiers
- DailyMed set ID ec7dd735-dc92-3d29-e053-2a95a90af549NDC 72189-385Application ANDA065325
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 mL in 1 bottle | 72189-385-32 | DirectRx | 21 October 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 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 Amoxil 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.