Medicine
Baxdela 300 mg/10.5 mL powder for injection
Baxdela 300 mg/10.5 mL powder for injection is a prescription medicine containing Delafloxacin for intravenous use, marketed by Melinta Therapeutics, 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
Do not freeze. BAXDELA Tablets and BAXDELA for Injection should be stored at…
Key facts
- Active ingredient (INN)
- Delafloxacin
- Brand
- Baxdela
- Strength
- 300 mg/10.5 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 10 vials
- Marketing authorisation holder
- Melinta Therapeutics
- Manufacturer
- Melinta Therapeutics
- Origin register
- US FDA, United States
- Storage
- Do not freeze. BAXDELA Tablets and BAXDELA for Injection should be stored at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). The reconstituted powder may be stored for up to 24 hours under refrigerated or controlled room temperature and then further diluted for intravenous infusion.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J01MA23 Delafloxacin
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 19 June 2017
- Identifiers
- RxCUI 1927667, 1927672, 1927677 +1DailyMed set ID fb77637a-88d9-4aea-958f-e270030ce30dNDC 70842-102Application NDA208611
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 vial, glass in 1 carton / 10.5 mL in 1 vial, glass | 70842-102-03 | Melinta Therapeutics | 19 June 2017 |
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.
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 Delafloxacin
Clinical summary
Delafloxacin is a fluoroquinolone antibacterial indicated for the treatment of adults with infections caused by designated susceptible bacteria, among other approved uses. It is available as powder for injection and tablets for intravenous and oral use. MedsAcross supplies Delafloxacin 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 DelafloxacinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Baxdela prescribing information (Melinta Therapeutics) · U.S. National Library of Medicine, DailyMed
- Quofenix: European public assessment report (EPAR) · European Medicines Agency
Need Baxdela 300 mg/10.5 mL powder for injection 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.