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Cephalexin 125 mg/5 mL powder for oral suspension

Cephalexin · Oral
Available on requestPrescription onlyUS FDAGeneric name

Cephalexin 125 mg/5 mL powder for oral suspension is a generic prescription medicine for oral use, made by 8 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 at 20o to 25o C (68o to 77o F). Keep tightly closed. *After mixing…

Key facts

Active ingredient (INN)
Cephalexin
Brand
Sold under the generic name
Strength
125 mg/5 mL
Dosage form
Powder for oral suspension
Route
Oral
Packs
200 mL, 100 mL and 14 more
Manufacturers
Ascend LaboratoriesIndiaAurobindo PharmaIndiaLupinIndiaBryant Ranch PrepackChartwell RXPreferred PharmaceuticlasTeva PharmaceuticalsNuCare Pharmaceuticals,Inc
Origin register
US FDA, United States
Storage
Store at 20o to 25o C (68o to 77o F). Keep tightly closed. *After mixing, store in refrigerator.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
J01DB01 Cephalexin
HS code (indicative)
3004.20Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
30 September 1990
Identifiers
RxCUI 309110, 309113DailyMed set ID 92be9844-0775-4808-bdeb-dccb09647d91, 655f38e8-1c4d-4cbc-9f52-bb881f065b2d, ada33464-b416-9ac6-e053-2a95a90af787 +7NDC 72162-1850, 59651-322, 68071-2246 +7Application ANDA210221, ANDA213568, ANDA065234 +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

Packs from every labeler of this generic presentation.

PackCodeLabelerMarketed since
200 mL in 1 bottle67877-544-68Ascend LaboratoriesIndia28 March 2019
100 mL in 1 bottle67877-544-88Ascend LaboratoriesIndia28 March 2019
100 mL in 1 bottle59651-322-01Aurobindo PharmaIndia9 June 2026
200 mL in 1 bottle59651-322-02Aurobindo PharmaIndia9 June 2026
100 mL in 1 bottle68180-440-01LupinIndia21 August 2017
200 mL in 1 bottle68180-440-02LupinIndia6 September 2017
100 mL in 1 bottle62135-480-42Chartwell RX1 February 2022
200 mL in 1 bottle62135-480-49Chartwell RX1 February 2022
100 mL in 1 bottle0093-4175-73Teva Pharmaceuticals30 September 1990
200 mL in 1 bottle0093-4175-74Teva Pharmaceuticals30 September 1990
100 mL in 1 bottle63629-9204-1Bryant Ranch Prepack28 March 2019
200 mL in 1 bottle63629-9205-1Bryant Ranch Prepack28 March 2019
100 mL in 1 bottle72162-1850-1Bryant Ranch Prepack7 March 2024
200 mL in 1 bottle72162-1850-2Bryant Ranch Prepack7 March 2024
100 mL in 1 bottle68071-2246-0NuCare Pharmaceuticals,Inc24 August 2020
100 mL in 1 bottle68788-7796-1Preferred Pharmaceuticlas13 October 2020
200 mL in 1 bottle68788-7796-2Preferred Pharmaceuticlas13 October 2020

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 January 1971Drugs@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 Cephalexin

Clinical summary

Cephalexin is a cephalosporin antibacterial indicated for the treatment of infections when caused by susceptible strains of the designated microorganisms. It is available as capsules, powder for oral suspension and tablets. MedsAcross supplies Cephalexin 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 Cephalexin

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

Data sources

Need Cephalexin 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.