Medicine
Cefdinir 125 mg/5 mL powder for oral suspension
Cefdinir 125 mg/5 mL powder for oral suspension 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 unsuspended powder at 20° to 25°C (68° to 77°F). Once reconstituted, the…
Key facts
- Active ingredient (INN)
- Cefdinir
- Brand
- Sold under the generic name
- Strength
- 125 mg/5 mL
- Dosage form
- Powder for oral suspension
- Route
- Oral
- Packs
- 100 mL, 60 mL, 1 bottle and 20 more
- Manufacturers
- Ascend LaboratoriesIndiaAurobindo PharmaIndiaLupinIndiaNuCare Pharmaceuticals,IncA-S Medication SolutionsAsclemedPreferred PharmaceuticalsProficient RxTeva PharmaceuticalsDirect_Rx
- Origin register
- US FDA, United States
- Storage
- Store unsuspended powder at 20° to 25°C (68° to 77°F). Once reconstituted, the oral suspension can be stored at controlled room temperature for 10 days.
- 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
- 31 May 2006
- Identifiers
- RxCUI 309054, 476576DailyMed set ID efb5a975-75ec-46e1-ba84-f68d0b9bf36f, 2bd2101c-511d-45a9-b1d8-a45ed40c5b80, a1f49fe1-b511-4f6b-a912-8ae8662d95a5 +13NDC 67877-547, 50090-7929, 0093-4136 +13Application ANDA210534, ANDA065332, ANDA065473 +1
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 | 67877-547-88 | Ascend LaboratoriesIndia | 20 February 2021 |
| 60 mL in 1 bottle | 67877-547-98 | Ascend LaboratoriesIndia | 20 February 2021 |
| 1 bottle in 1 carton / 100 mL in 1 bottle | 65862-218-01 | Aurobindo PharmaIndia | 14 December 2007 |
| 1 bottle in 1 carton / 60 mL in 1 bottle | 65862-218-60 | Aurobindo PharmaIndia | 14 December 2007 |
| 60 mL in 1 bottle | 68180-722-04 | LupinIndia | 22 May 2020 |
| 100 mL in 1 bottle | 68180-722-05 | LupinIndia | 22 May 2020 |
| 60 mL in 1 bottle | 0093-4136-64 | Teva Pharmaceuticals | 8 May 2007 |
| 100 mL in 1 bottle | 0093-4136-73 | Teva Pharmaceuticals | 8 May 2007 |
| 60 mL in 1 bottle | 68071-3156-6 | NuCare Pharmaceuticals | 16 March 2017 |
| 60 mL in 1 bottle | 68071-3609-6 | NuCare Pharmaceuticals,Inc | 25 June 2024 |
| 100 mL in 1 bottle | 68071-3806-1 | NuCare Pharmaceuticals | 6 March 2025 |
| 60 mL in 1 bottle | 68071-4970-6 | NuCare Pharmaceuticals,Inc | 18 July 2019 |
| 1 bottle in 1 carton / 100 mL in 1 bottle | 68071-5318-1 | NuCare Pharmaceuticals | 1 September 2026 |
| 60 mL in 1 bottle | 50090-4258-0 | A-S Medication Solutions | 9 April 2019 |
| 1 bottle in 1 carton / 60 mL in 1 bottle | 50090-6417-0 | A-S Medication Solutions | 30 March 2023 |
| 60 mL in 1 bottle | 50090-7929-0 | A-S Medication Solutions | 9 March 2026 |
| 100 mL in 1 bottle | 76420-327-01 | Asclemed | 19 April 2025 |
| 60 mL in 1 bottle | 76420-327-60 | Asclemed | 19 April 2025 |
| 60 mL in 1 bottle | 72189-185-32 | Direct RX | 12 April 2021 |
| 100 mL in 1 bottle | 68788-8115-1 | Preferred Pharmaceuticals | 21 March 2024 |
| 60 mL in 1 bottle | 68788-8115-6 | Preferred Pharmaceuticals | 7 December 2021 |
| 1 bottle in 1 carton / 100 mL in 1 bottle | 63187-835-00 | Proficient Rx | 1 May 2017 |
| 1 bottle in 1 carton / 60 mL in 1 bottle | 63187-835-60 | Proficient Rx | 1 May 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 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.