Medicine
Cephalexin 333 mg capsule
Cephalexin 333 mg capsule is a generic prescription medicine for oral use, made by 3 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°C to 25°C (68°F to77°F), excursions permitted to 15 to 30°C (59 to…
Key facts
- Active ingredient (INN)
- Cephalexin
- Brand
- Sold under the generic name
- Strength
- 333 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 500 capsules, 1000 capsules and 8 more
- Manufacturers
- Ascend LaboratoriesIndiaHawaii RepackAsclemed
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to77°F), excursions permitted to 15 to 30°C (59 to 86°F).
- 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
- 4 June 2012
- Identifiers
- RxCUI 309112, 309114, 637173 +1DailyMed set ID 8073f183-e11f-41af-8bd1-1505bc7e044b, 4fec8daf-6e09-4153-926f-64709dbdd26c, d54abc0a-3c8f-4f02-bd55-406f0c5b925aNDC 76420-593, 67877-254, 85534-0077Application ANDA090836
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 capsule in 1 bottle | 67877-254-01 | Ascend LaboratoriesIndia | 4 June 2012 |
| 500 capsule in 1 bottle | 67877-254-05 | Ascend LaboratoriesIndia | 4 June 2012 |
| 1000 capsule in 1 bottle | 67877-254-10 | Ascend LaboratoriesIndia | 4 June 2012 |
| 20 capsule in 1 bottle | 67877-254-20 | Ascend LaboratoriesIndia | 4 June 2012 |
| 100 blister pack in 1 carton / 1 capsule in 1 blister pack | 67877-254-38 | Ascend LaboratoriesIndia | 4 June 2012 |
| 100 capsule in 1 bottle | 76420-593-10 | Asclemed | 1 September 2023 |
| 1 capsule in 1 bottle | 85534-0077-0 | Hawaii Repack | 13 July 2026 |
| 14 capsule in 1 bottle | 85534-0077-1 | Hawaii Repack | 13 July 2026 |
| 20 capsule in 1 bottle | 85534-0077-2 | Hawaii Repack | 13 July 2026 |
| 30 capsule in 1 bottle | 85534-0077-3 | Hawaii Repack | 13 July 2026 |
| 100 capsule in 1 bottle | 85534-0077-4 | Hawaii Repack | 13 July 2026 |
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 January 1971 | 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 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 CephalexinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Cephalexin prescribing information (Ascend Laboratories) · U.S. National Library of Medicine, DailyMed
Need Cephalexin 333 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.