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Medicine

Cefdinir 250 mg/5 mL powder for oral suspension

Cefdinir · Oral
Available on requestPrescription onlyUS FDAGeneric name

Cefdinir 250 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store dry powder and reconstituted suspension at 20° to 25°C (68° to 77°F),.

Key facts

Active ingredient (INN)
Cefdinir
Brand
Sold under the generic name
Strength
250 mg/5 mL
Dosage form
Powder for oral suspension
Route
Oral
Packs
100 mL, 60 mL, 1 bottle and 26 more
Manufacturers
Ascend LaboratoriesIndiaAurobindo PharmaIndiaLupinIndiaA-S Medication SolutionsProficient RxDirect_RxAsclemedNuCare Pharmaceuticals,IncPreferred PharmaceuticalsTeva Pharmaceuticals
Origin register
US FDA, United States
Storage
Store dry powder and reconstituted suspension 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
7 May 2007
Identifiers
RxCUI 309054, 476576DailyMed set ID 982d0f53-20bc-1cb4-e053-2995a90ad33c, 0eeac6df-bad7-413e-8b41-0660f3a99373, 42a2d8f5-12bc-4745-b9d4-e69ba6c66647 +17NDC 72189-043, 50090-3725, 50090-8104 +19Application ANDA065259, ANDA065332, ANDA210534 +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.

PackCodeLabelerMarketed since
100 mL in 1 bottle67877-548-88Ascend LaboratoriesIndia20 February 2021
60 mL in 1 bottle67877-548-98Ascend LaboratoriesIndia20 February 2021
1 bottle in 1 carton / 100 mL in 1 bottle65862-219-01Aurobindo PharmaIndia14 December 2007
1 bottle in 1 carton / 60 mL in 1 bottle65862-219-60Aurobindo PharmaIndia14 December 2007
60 mL in 1 bottle68180-723-04LupinIndia22 May 2020
100 mL in 1 bottle68180-723-05LupinIndia22 May 2020
60 mL in 1 bottle0093-4137-64Teva Pharmaceuticals8 May 2007
100 mL in 1 bottle0093-4137-73Teva Pharmaceuticals8 May 2007
1 bottle in 1 carton / 60 mL in 1 bottle50090-2735-0A-S Medication Solutions29 December 2016
100 mL in 1 bottle50090-3723-0A-S Medication Solutions25 October 2018
60 mL in 1 bottle50090-3725-0A-S Medication Solutions25 October 2018
60 mL in 1 bottle50090-5811-0A-S Medication Solutions18 October 2021
60 mL in 1 bottle50090-6171-0A-S Medication Solutions14 October 2022
100 mL in 1 bottle50090-8104-0A-S Medication Solutions7 October 2026
5 mL in 1 bottle72189-043-32Direct RX25 November 2019
60 mL in 1 bottle72189-186-32Direct RX12 April 2021
100 mL in 1 bottle72189-259-32Direct RX13 September 2021
100 mL in 1 bottle68788-4106-1Preferred Pharmaceuticals21 April 2026
100 mL in 1 bottle68788-8655-1Preferred Pharmaceuticals9 May 2024
100 mL in 1 bottle63187-616-00Proficient Rx8 May 2007
60 mL in 1 bottle63187-616-60Proficient Rx8 May 2007
100 mL in 1 bottle71205-380-00Proficient Rx3 June 2021
60 mL in 1 bottle71205-380-60Proficient Rx6 January 2020
1 bottle in 1 carton / 100 mL in 1 bottle71205-405-00Proficient Rx18 February 2020
1 bottle in 1 carton / 60 mL in 1 bottle71205-405-60Proficient Rx28 May 2020
100 mL in 1 bottle68071-3403-1NuCare Pharmaceuticals,Inc16 May 2023
60 mL in 1 bottle68071-5106-6NuCare Pharmaceuticals,Inc7 November 2019
100 mL in 1 bottle76420-328-01Asclemed19 April 2025
60 mL in 1 bottle76420-328-60Asclemed19 April 2025

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 4 December 1997Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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 Cefdinir

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Cefdinir 250 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.