Medicine
Dalbavancin 500 mg/25 mL powder for injection
Dalbavancin 500 mg/25 mL powder for injection is a generic prescription medicine for intravenous 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
Storage of the reconstituted and diluted solutions of dalbavancin for…
Key facts
- Active ingredient (INN)
- Dalbavancin
- Brand
- Sold under the generic name
- Strength
- 500 mg/25 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial and 2 more
- Manufacturers
- BE PharmaceuticalsFresenius KabiMeitheal PharmaceuticalsSomerset TherapeuticsTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Storage of the reconstituted and diluted solutions of dalbavancin for injection are described elsewhere in the prescribing information.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J01XA04 Dalbavancin
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 October 2025
- Identifiers
- RxCUI 1539243DailyMed set ID 2c2ec45e-48a2-4887-8ab0-9244eb39a394, f4c0bd0f-03c2-4ce5-bcc2-b58f21ce75c1, 966995bb-9d92-434d-b75a-1786072b81c9 +2NDC 65219-120, 70069-830, 71288-034 +2Application ANDA217591, ANDA219604, ANDA218929 +1
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 |
|---|---|---|---|
| 1 vial in 1 carton / 25 mL in 1 vial | 71839-144-01 | BE Pharmaceuticals | 12 June 2026 |
| 1 vial in 1 package / 25 mL in 1 vial | 65219-120-12 | Fresenius Kabi | 10 November 2025 |
| 1 vial, single-dose in 1 carton / 25 mL in 1 vial, single-dose | 71288-034-50 | Meitheal Pharmaceuticals | 26 November 2025 |
| 1 vial in 1 carton / 25 mL in 1 vial | 70069-830-01 | Somerset Therapeutics | 27 July 2026 |
| 1 vial in 1 carton / 25 mL in 1 vial | 0480-3325-01 | Teva Pharmaceuticals | 29 October 2025 |
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
Alternatives
Other makers and brands of Dalbavancin 500 mg/25 mL powder for injection.
Other strengths and forms of Dalbavancin
Clinical summary
Dalbavancin is a lipoglycopeptide antibacterial indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms, among other approved uses. MedsAcross supplies Dalbavancin 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 DalbavancinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- DALVANCE prescribing information (Allergan) · U.S. National Library of Medicine, DailyMed
- Xydalba: European public assessment report (EPAR) · European Medicines Agency
Need Dalbavancin 500 mg/25 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.