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MedsAcross

Medicine

Cefaclor 500 mg extended-release tablet

Cefaclor · Oral
Available on requestPrescription onlyUS FDAGeneric name

Cefaclor 500 mg extended-release tablet is a generic prescription medicine for oral use, 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 20° to 25°C (68° to 77°F).

Key facts

Active ingredient (INN)
Cefaclor
Brand
Sold under the generic name
Strength
500 mg
Dosage form
Extended-release tablet
Route
Oral
Packs
100 tablets
Manufacturer
Teva Pharmaceuticals
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
J01DC04 Cefaclor
HS code (indicative)
3004.20Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
26 September 2002
Identifiers
RxCUI 309043DailyMed set ID 0878bdc2-0410-4938-9890-96523aa81c2fNDC 0093-1087Application ANDA065058

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

PackCodeLabelerMarketed since
100 tablet, film coated, extended release in 1 bottle0093-1087-01Teva Pharmaceuticals26 September 2002

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 April 1979Drugs@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 Cefaclor

Clinical summary

Cefaclor is a cephalosporin antibacterial indicated in the treatment of infections when caused by susceptible strains of the designated microorganisms. It is available as capsules, extended-release tablets and oral suspension. MedsAcross supplies Cefaclor 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 Cefaclor

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

Data sources

Need Cefaclor 500 mg extended-release tablet 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.