Medicine
Amoxicillin 500 mg tablet
Amoxicillin 500 mg tablet is a generic prescription medicine for oral use, made by 10 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 at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Amoxicillin
- Brand
- Sold under the generic name
- Strength
- 500 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 20 tablets and 17 more
- Manufacturers
- Aurobindo PharmaIndiaNuCare Pharmaceuticals,IncA-S Medication SolutionsAsclemedChartwell RXRemedyrepackRising Pharma HoldingsAmerican Health PackagingSandozTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store 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
- 21 November 2000
- Identifiers
- RxCUI 308192, 308194, 239191 +7DailyMed set ID a18751fa-6202-4ae2-950a-a3f1dc9a8afd, 20eb4ade-f3b8-db66-e063-6294a90ae846, 3e4f0f03-438b-ddfb-e063-6294a90adb38 +11NDC 76420-838, 68071-3675, 68071-3890 +11Application ANDA065256, ANDA065228, ANDA065056
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 tablet, film coated in 1 bottle | 65862-014-01 | Aurobindo PharmaIndia | 9 November 2005 |
| 500 tablet, film coated in 1 bottle | 65862-014-05 | Aurobindo PharmaIndia | 9 November 2005 |
| 20 tablet, film coated in 1 bottle | 65862-014-20 | Aurobindo PharmaIndia | 9 November 2005 |
| 100 tablet, film coated in 1 bottle | 62135-084-01 | Chartwell RX | 16 July 2026 |
| 60 tablet, film coated in 1 bottle | 62135-084-60 | Chartwell RX | 16 July 2026 |
| 100 tablet, film coated in 1 bottle | 57237-028-01 | Rising Pharma Holdings | 9 November 2005 |
| 20 tablet, film coated in 1 bottle | 57237-028-20 | Rising Pharma Holdings | 9 November 2005 |
| 100 tablet, film coated in 1 bottle | 0781-5060-01 | Sandoz | 13 July 2005 |
| 100 tablet, film coated in 1 bottle | 0093-2263-01 | Teva Pharmaceuticals | 21 November 2000 |
| 100 tablet, film coated in 1 bottle | 68071-2911-1 | NuCare Pharmaceuticals,Inc | 10 January 2023 |
| 20 tablet, film coated in 1 bottle | 68071-3675-2 | NuCare Pharmaceuticals | 30 August 2024 |
| 20 tablet, film coated in 1 bottle | 68071-3872-2 | NuCare Pharmaceuticals,Inc | 26 June 2025 |
| 100 tablet, film coated in 1 bottle | 68071-3890-1 | NuCare Pharmaceuticals,Inc | 8 September 2025 |
| 20 tablet, film coated in 1 bottle | 50090-0709-0 | A-S Medication Solutions | 28 November 2014 |
| 20 tablet, film coated in 1 bottle | 50090-1825-0 | A-S Medication Solutions | 13 May 2015 |
| 30 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack | 60687-798-25 | American Health Packaging | 25 March 2025 |
| 100 tablet, film coated in 1 bottle | 76420-838-01 | Asclemed | 21 August 2024 |
| 20 tablet, film coated in 1 bottle | 76420-838-20 | Asclemed | 21 August 2024 |
| 100 pouch in 1 box / 1 tablet, film coated in 1 pouch | 70518-3886-0 | Remedyrepack | 5 October 2023 |
| 21 tablet, film coated in 1 bottle, plastic | 70518-3886-2 | Remedyrepack | 2 September 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 500 mg tablet 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.