Medicine
Utebzi 300 mg tablet
Utebzi 300 mg tablet is a prescription medicine containing Tebipenem for oral use, marketed by GlaxoSmithKline, 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 to 77°F), excursions permitted between 15°C to…
Key facts
- Active ingredient (INN)
- Tebipenem
- Brand
- Utebzi
- Strength
- 300 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 10 blister pack
- Marketing authorisation holder
- GlaxoSmithKline
- Manufacturer
- GlaxoSmithKline
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 October 2026
- Identifiers
- DailyMed set ID f0511453-5f6f-4e3a-b7d0-a5cfde985656NDC 0173-0956Application NDA215960
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 10 blister pack in 1 carton / 8 tablet, film coated in 1 blister pack | 0173-0956-76 | GlaxoSmithKline | 1 October 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 17 June 2026 | 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
Clinical summary
Tebipenem is a prescription medicine indicated for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible microorganisms, among other approved uses. It is available as tablets for oral use. MedsAcross supplies Tebipenem 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 TebipenemFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Utebzi prescribing information (GlaxoSmithKline) · U.S. National Library of Medicine, DailyMed
Need Utebzi 300 mg 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.