Medicine
Cefdinir 300 mg capsule
Cefdinir 300 mg capsule is a generic prescription medicine for oral use, made by 22 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).
Key facts
- Active ingredient (INN)
- Cefdinir
- Brand
- Sold under the generic name
- Strength
- 300 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 10 blister pack, 60 capsules and 85 more
- Manufacturers
- Ascend LaboratoriesIndiaAurobindo PharmaIndiaLupinIndiaNuCare Pharmaceuticals,IncPD-Rx PharmaceuticalsA-S Medication SolutionsSandozRising Pharma HoldingsTeva Pharmaceuticals22 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store 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
- J01DD15 Cefdinir
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 30 May 2006
- Identifiers
- RxCUI 200346DailyMed set ID 1acc5d17-10a4-e23d-e063-6394a90a52c3, 18888955-4db3-4d0d-939f-eaaa5f2e0dc4, c23af6af-a97b-b98d-e053-2995a90ae780 +37NDC 42291-043, 67877-543, 68071-2401 +37Application ANDA065368, ANDA210220, ANDA065434 +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
A sample of 40 packs from 22 labelers. The register lists 88 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 capsule in 1 bottle | 67877-543-01 | Ascend LaboratoriesIndia | 20 February 2021 |
| 10 blister pack in 1 carton / 10 capsule in 1 blister pack | 67877-543-38 | Ascend LaboratoriesIndia | 20 February 2021 |
| 60 capsule in 1 bottle | 67877-543-60 | Ascend LaboratoriesIndia | 20 February 2021 |
| 500 capsule in 1 bottle | 65862-177-05 | Aurobindo PharmaIndia | 7 January 2008 |
| 30 capsule in 1 bottle | 65862-177-30 | Aurobindo PharmaIndia | 7 January 2008 |
| 60 capsule in 1 bottle | 65862-177-60 | Aurobindo PharmaIndia | 7 January 2008 |
| 60 capsule in 1 bottle | 68180-711-60 | LupinIndia | 30 May 2006 |
| 60 capsule in 1 bottle | 57237-099-60 | Rising Pharma Holdings | 7 January 2008 |
| 100 capsule in 1 bottle | 0781-2176-01 | Sandoz | 6 April 2007 |
| 60 capsule in 1 bottle | 0781-2176-60 | Sandoz | 6 April 2007 |
| 3 carton in 1 carton / 1 blister pack in 1 carton / 10 capsule in 1 blister pack | 0781-2176-64 | Sandoz | 6 April 2007 |
| 5 blister pack in 1 carton / 10 capsule in 1 blister pack | 0781-2176-69 | Sandoz | 6 April 2007 |
| 60 capsule in 1 bottle | 0093-3160-06 | Teva Pharmaceuticals | 9 May 2007 |
| 2 capsule in 1 bottle | 68071-2401-2 | NuCare Pharmaceuticals,Inc | 13 May 2021 |
| 20 capsule in 1 bottle | 68071-2503-2 | NuCare Pharmaceuticals,Inc | 20 February 2021 |
| 30 capsule in 1 bottle | 68071-2503-3 | NuCare Pharmaceuticals,Inc | 14 January 2025 |
| 2 capsule in 1 bottle | 68071-3998-2 | NuCare Pharmaceuticals | 6 May 2026 |
| 20 capsule in 1 bottle | 68071-4007-2 | NuCare Pharmaceuticals,Inc | 19 July 2017 |
| 30 capsule in 1 bottle | 68071-4007-3 | NuCare Pharmaceuticals,Inc | 19 July 2017 |
| 14 capsule in 1 bottle | 68071-4007-7 | NuCare Pharmaceuticals,Inc | 19 July 2017 |
| 20 capsule in 1 bottle | 68071-4856-2 | NuCare Pharmaceuticals,Inc | 17 April 2019 |
| 14 capsule in 1 bottle | 68071-4856-7 | NuCare Pharmaceuticals,Inc | 17 April 2019 |
| 2 capsule in 1 bottle | 68071-4946-2 | NuCare Pharmaceuticals,Inc | 26 June 2019 |
| 20 capsule in 1 bottle | 68071-5145-2 | NuCare Pharmaceuticals,Inc | 8 January 2020 |
| 14 capsule in 1 bottle | 68071-5145-7 | NuCare Pharmaceuticals,Inc | 3 December 2025 |
| 14 capsule in 1 bottle, plastic | 43063-959-14 | PD-Rx Pharmaceuticals | 12 March 2024 |
| 20 capsule in 1 bottle, plastic | 43063-959-20 | PD-Rx Pharmaceuticals | 1 April 2019 |
| 14 capsule in 1 bottle, plastic | 43063-964-14 | PD-Rx Pharmaceuticals | 5 April 2019 |
| 20 capsule in 1 bottle, plastic | 43063-964-20 | PD-Rx Pharmaceuticals | 10 April 2019 |
| 14 capsule in 1 bottle, plastic | 72789-054-14 | PD-Rx Pharmaceuticals | 21 February 2020 |
| 20 capsule in 1 bottle, plastic | 72789-054-20 | PD-Rx Pharmaceuticals | 21 February 2020 |
| 20 capsule in 1 bottle, plastic | 72789-061-20 | PD-Rx Pharmaceuticals | 11 March 2020 |
| 10 capsule in 1 bottle, plastic | 72789-550-10 | PD-Rx Pharmaceuticals | 24 February 2026 |
| 10 capsule in 1 bottle | 50090-1033-0 | A-S Medication Solutions | 9 October 2019 |
| 20 capsule in 1 bottle | 50090-1033-1 | A-S Medication Solutions | 28 November 2014 |
| 14 capsule in 1 bottle | 50090-1033-2 | A-S Medication Solutions | 9 October 2019 |
| 10 capsule in 1 bottle | 50090-2719-0 | A-S Medication Solutions | 4 October 2019 |
| 20 capsule in 1 bottle | 50090-2719-1 | A-S Medication Solutions | 20 December 2016 |
| 14 capsule in 1 bottle | 50090-2719-2 | A-S Medication Solutions | 20 December 2016 |
| 30 capsule in 1 bottle | 50090-2719-3 | A-S Medication Solutions | 6 January 2017 |
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 4 December 1997 | 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 Cefdinir
Clinical summary
Cefdinir is a cephalosporin antibacterial indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. MedsAcross supplies Cefdinir 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 CefdinirFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- cefdinir prescribing information (Ascend Laboratories) · U.S. National Library of Medicine, DailyMed
Need Cefdinir 300 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.