Medicine
Cefixime 400 mg capsule
Cefixime 400 mg capsule is a generic prescription medicine for oral use, made by 5 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 drug powder at 20°C to 25°C (68°F to 77°F). Cefixime capsules, 400 mg is…
Key facts
- Active ingredient (INN)
- Cefixime
- Brand
- Sold under the generic name
- Strength
- 400 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 500 capsules, 10 blister pack and 12 more
- Manufacturers
- Ascend LaboratoriesIndiaAurobindo PharmaIndiaLupinIndiaRemedyrepackHealth Department, Oklahoma State
- Origin register
- US FDA, United States
- Storage
- Store drug powder at 20°C to 25°C (68°F to 77°F). Cefixime capsules, 400 mg is size "0" capsule with pink opaque cap and pink opaque body, imprinted with "LU" on cap and "U43" on body in black ink, containing white to yellowish white granular powder containing 400 mg of cefixime as the trihydrate and is supplied as follows: NDC 68180-423-08 - Bottle of 50 capsules NDC 68180-423-11 - Unit dose…
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J01DD08 Cefixime
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 12 October 2018
- Identifiers
- RxCUI 309058, 409823, 419849DailyMed set ID 6d68dbd9-7d75-4ff1-91db-79ff8ae879ec, 9cdb156f-7a99-413e-b49a-ffafaf9e93fe, d6718f02-8eea-4c2f-9aa2-65121d9a6e4c +4NDC 68180-423, 59651-647, 70518-2749 +4Application NDA203195, ANDA217607, ANDA210574
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 | 67877-584-01 | Ascend LaboratoriesIndia | 12 October 2018 |
| 500 capsule in 1 bottle | 67877-584-05 | Ascend LaboratoriesIndia | 12 October 2018 |
| 10 blister pack in 1 carton / 10 capsule in 1 blister pack | 67877-584-33 | Ascend LaboratoriesIndia | 26 November 2020 |
| 50 capsule in 1 bottle | 67877-584-50 | Ascend LaboratoriesIndia | 12 October 2018 |
| 1 blister pack in 1 carton / 10 capsule in 1 blister pack | 59651-647-10 | Aurobindo PharmaIndia | 23 March 2026 |
| 50 capsule in 1 bottle | 59651-647-50 | Aurobindo PharmaIndia | 23 March 2026 |
| 50 capsule in 1 bottle | 68180-423-08 | LupinIndia | 14 October 2020 |
| 1 blister pack in 1 carton / 10 capsule in 1 blister pack | 68180-423-11 | LupinIndia | 14 October 2020 |
| 2 capsule in 1 packet | 83112-400-00 | Health Department, Oklahoma State | 12 October 2018 |
| 2 capsule in 1 packet | 83112-400-02 | Health Department, Oklahoma State | 12 October 2018 |
| 2 capsule in 1 bottle, plastic | 70518-2749-2 | Remedyrepack | 26 January 2021 |
| 2 pouch in 1 box / 1 capsule in 1 pouch | 70518-2749-5 | Remedyrepack | 7 July 2023 |
| 2 pouch in 1 box / 1 capsule in 1 pouch | 70518-3221-2 | Remedyrepack | 4 November 2021 |
| 2 capsule in 1 bottle, plastic | 70518-3221-4 | Remedyrepack | 2 March 2022 |
| 2 capsule in 1 bottle, plastic | 70518-4759-0 | Remedyrepack | 21 September 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 28 April 1989 | 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 Cefixime
Clinical summary
Cefixime is a cephalosporin antibacterial indicated in the treatment of adults and pediatric patients six months and older with infections, among other approved uses. It is available as capsules, powder for oral suspension and tablets. MedsAcross supplies Cefixime 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 CefiximeFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- CEFIXIME prescribing information (Lupin) · U.S. National Library of Medicine, DailyMed
Need Cefixime 400 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.