Medicine
Cefadroxil 500 mg capsule
Cefadroxil 500 mg capsule 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 at 25°C (77°F), excursions permitted to 15° to 30° C (59° to 86° F).
Key facts
- Active ingredient (INN)
- Cefadroxil
- Brand
- Sold under the generic name
- Strength
- 500 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 50 capsules, 6 capsules and 59 more
- Manufacturers
- Aurobindo PharmaIndiaLupinIndiaRedpharm DrugAdvanced Rx Pharmacy of TennesseeDirect_RxNuCare Pharmaceuticals,IncBryant Ranch PrepackPD-Rx PharmaceuticalsRising Pharma HoldingsTeva Pharmaceuticals16 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (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
- J01DB05 Cefadroxil
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 January 2007
- Identifiers
- RxCUI 309049DailyMed set ID 205cb17b-6fbf-e147-e063-6294a90a608e, 8cdaac56-b84a-4b6b-b94d-cab15d5961c5, 7bb90096-14d3-400e-94d3-048bff6b1292 +28NDC 80425-0432, 63629-7987, 65862-085 +28Application ANDA065392, ANDA065352, ANDA065282
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 62 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 capsule in 1 bottle | 65862-085-01 | Aurobindo PharmaIndia | 25 January 2007 |
| 50 capsule in 1 bottle | 65862-085-50 | Aurobindo PharmaIndia | 25 January 2007 |
| 100 capsule in 1 bottle | 68180-180-01 | LupinIndia | 23 April 2008 |
| 50 capsule in 1 bottle | 68180-180-08 | LupinIndia | 23 April 2008 |
| 100 capsule in 1 bottle | 57237-096-01 | Rising Pharma Holdings | 25 January 2007 |
| 50 capsule in 1 bottle | 57237-096-50 | Rising Pharma Holdings | 25 January 2007 |
| 100 capsule in 1 bottle | 0093-3196-01 | Teva Pharmaceuticals | 31 January 2007 |
| 50 capsule in 1 bottle | 0093-3196-53 | Teva Pharmaceuticals | 31 January 2007 |
| 6 capsule in 1 bottle | 68071-3597-6 | NuCare Pharmaceuticals,Inc | 25 April 2024 |
| 10 capsule in 1 bottle | 68071-4515-1 | NuCare Pharmaceuticals,Inc | 2 August 2018 |
| 20 capsule in 1 bottle | 68071-4515-2 | NuCare Pharmaceuticals,Inc | 2 August 2018 |
| 6 capsule in 1 bottle | 68071-4690-6 | NuCare Pharmaceuticals,Inc | 3 January 2019 |
| 10 capsule in 1 bottle | 68071-4938-1 | NuCare Pharmaceuticals,Inc | 21 June 2019 |
| 6 capsule in 1 bottle | 68071-5234-6 | NuCare Pharmaceuticals,Inc | 30 March 2020 |
| 20 capsule in 1 bottle | 63629-7987-1 | Bryant Ranch Prepack | 3 April 2024 |
| 30 capsule in 1 bottle | 63629-7988-1 | Bryant Ranch Prepack | 3 April 2024 |
| 14 capsule in 1 bottle | 63629-8253-1 | Bryant Ranch Prepack | 3 April 2024 |
| 20 capsule in 1 bottle | 63629-9456-1 | Bryant Ranch Prepack | 20 June 2025 |
| 20 capsule in 1 bottle | 67296-0491-1 | Redpharm Drug | 23 April 2008 |
| 14 capsule in 1 bottle | 67296-0491-2 | Redpharm Drug | 23 April 2008 |
| 40 capsule in 1 bottle | 67296-0491-4 | Redpharm Drug | 23 April 2008 |
| 14 capsule in 1 bottle | 67296-1727-1 | RedPharm Drug | 1 November 2019 |
| 20 capsule in 1 bottle | 67296-1727-2 | RedPharm Drug | 1 November 2019 |
| 14 capsule in 1 bottle | 67296-2199-1 | Redpharm Drug | 31 January 2007 |
| 20 capsule in 1 bottle | 67296-2221-2 | Redpharm Drug | 25 January 2007 |
| 40 capsule in 1 bottle | 67296-2221-4 | Redpharm Drug | 25 January 2007 |
| 6 capsule in 1 bottle | 72189-103-06 | Direct RX | 12 June 2020 |
| 20 capsule in 1 bottle | 72189-103-20 | Direct RX | 12 June 2020 |
| 6 capsule in 1 bottle | 72189-445-06 | Direct_Rx | 14 March 2023 |
| 20 capsule in 1 bottle | 72189-445-20 | Direct_Rx | 14 March 2023 |
| 6 capsule in 1 bottle | 72189-506-06 | Direct_Rx | 7 August 2023 |
| 20 capsule in 1 bottle | 72189-506-20 | Direct_Rx | 7 August 2023 |
| 10 capsule in 1 bottle | 80425-0198-1 | Advanced Rx Pharmacy of Tennessee | 2 November 2023 |
| 30 capsule in 1 bottle | 80425-0198-2 | Advanced Rx Pharmacy of Tennessee | 2 November 2023 |
| 20 capsule in 1 bottle | 80425-0198-3 | Advanced Rx Pharmacy of Tennessee | 9 February 2024 |
| 10 capsule in 1 bottle | 80425-0400-1 | Advanced Rx Pharmacy of Tennessee | 7 June 2024 |
| 20 capsule in 1 bottle | 80425-0400-2 | Advanced Rx Pharmacy of Tennessee | 7 June 2024 |
| 30 capsule in 1 bottle | 80425-0400-3 | Advanced Rx Pharmacy of Tennessee | 7 June 2024 |
| 10 capsule in 1 bottle, plastic | 43063-553-10 | PD-Rx Pharmaceuticals | 11 September 2012 |
| 14 capsule in 1 bottle, plastic | 43063-553-14 | PD-Rx Pharmaceuticals | 11 September 2012 |
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 Cefadroxil
Clinical summary
Cefadroxil is a cephalosporin antibacterial indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in diseases. It is available as capsules, powder for oral suspension and tablets. MedsAcross supplies Cefadroxil 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 CefadroxilFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Cefadroxil prescribing information (Lupin) · U.S. National Library of Medicine, DailyMed
Need Cefadroxil 500 mg capsule 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.