Medicine
Vancomycin 500 mg/10 mL powder for injection
Vancomycin 500 mg/10 mL powder for injection is a generic prescription medicine for intravenous use, made by 13 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
Prior to reconstitution, store at 20°C to 25°C (68°F to 77°F), excursions…
Key facts
- Active ingredient (INN)
- Vancomycin
- Brand
- Sold under the generic name
- Strength
- 500 mg/10 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 10 vials, 25 vials, 1 bottle and 47 more
- Manufacturers
- EugiaIndiaCamber PharmaceuticalsIndiaGland PharmaIndiaGlenmark PharmaceuticalsIndiaSteriscience SpecialtiesIndiaFresenius KabiMylan InstitutionalSagent Pharmaceuticals13 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Prior to reconstitution, store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A07AA09 Vancomycin
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 September 2000
- Identifiers
- RxCUI 1807518, 2049888, 2049890 +7DailyMed set ID 2c355037-6a1e-4846-872a-471ccbdc8d54, 78984781-3c0b-4b73-ba85-10d60ecb2a28, 35ecffbc-77d8-4c0d-9b14-6a3cc442dec6 +29NDC 82449-007, 55150-203, 68083-569 +37Application ANDA215324, ANDA205780, ANDA205694 +16
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
A sample of 40 packs from 13 labelers. The register lists 50 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 10 vial in 1 carton / 10 mL in 1 vial | 55150-203-10 | EugiaIndia | 31 March 2016 |
| 10 vial in 1 carton / 20 mL in 1 vial | 55150-204-20 | EugiaIndia | 31 March 2016 |
| 10 vial, single-dose in 1 carton / 25 mL in 1 vial, single-dose | 55150-471-10 | EugiaIndia | 4 August 2023 |
| 10 vial, single-dose in 1 carton / 30 mL in 1 vial, single-dose | 55150-472-10 | EugiaIndia | 4 August 2023 |
| 25 vial in 1 carton / 10 mL in 1 vial | 68083-143-25 | Gland PharmaIndia | 23 February 2016 |
| 10 vial in 1 carton / 20 mL in 1 vial | 68083-144-10 | Gland PharmaIndia | 23 February 2016 |
| 1 bottle in 1 carton / 100 mL in 1 bottle | 68083-569-01 | Gland PharmaIndia | 6 June 2023 |
| 10 vial in 1 carton / 10 mL in 1 vial | 68462-955-51 | Glenmark PharmaceuticalsIndia | 12 April 2026 |
| 10 vial in 1 carton / 20 mL in 1 vial | 68462-956-11 | Glenmark PharmaceuticalsIndia | 12 April 2026 |
| 1 bottle in 1 carton / 100 mL in 1 bottle | 68462-957-05 | Glenmark PharmaceuticalsIndia | 12 October 2026 |
| 10 vial in 1 carton / 10 mL in 1 vial | 31722-210-10 | Camber PharmaceuticalsIndia | 6 July 2022 |
| 25 vial in 1 carton / 10 mL in 1 vial | 31722-210-32 | Camber PharmaceuticalsIndia | 6 July 2022 |
| 10 vial in 1 carton / 20 mL in 1 vial | 31722-211-10 | Camber PharmaceuticalsIndia | 6 July 2022 |
| 10 vial, single-dose in 1 carton / 30 mL in 1 vial, single-dose | 82449-007-02 | Steriscience SpecialtiesIndia | 15 December 2025 |
| 10 vial in 1 tray / 15 mL in 1 vial | 63323-203-20 | Fresenius Kabi | 17 August 2016 |
| 10 vial in 1 tray / 15 mL in 1 vial | 63323-203-26 | Fresenius Kabi | 17 August 2016 |
| 25 vial in 1 tray / 10 mL in 1 vial | 63323-221-10 | Fresenius Kabi | 1 September 2000 |
| 25 vial in 1 tray / 10 mL in 1 vial | 63323-221-16 | Fresenius Kabi | 3 May 2021 |
| 25 vial in 1 tray / 10 mL in 1 vial | 63323-221-38 | Fresenius Kabi | 1 November 2017 |
| 25 vial in 1 tray / 10 mL in 1 vial | 63323-221-48 | Fresenius Kabi | 26 October 2017 |
| 10 vial in 1 tray / 20 mL in 1 vial | 63323-284-20 | Fresenius Kabi | 20 September 2000 |
| 10 vial in 1 tray / 20 mL in 1 vial | 63323-284-21 | Fresenius Kabi | 20 September 2000 |
| 10 vial in 1 tray / 20 mL in 1 vial | 63323-284-26 | Fresenius Kabi | 3 May 2021 |
| 10 vial in 1 tray / 20 mL in 1 vial | 63323-284-45 | Fresenius Kabi | 26 October 2017 |
| 1 bottle in 1 carton / 100 mL in 1 bottle | 63323-295-61 | Fresenius Kabi | 17 July 2001 |
| 1 bottle in 1 carton / 100 mL in 1 bottle | 63323-295-66 | Fresenius Kabi | 17 July 2001 |
| 10 vial in 1 carton / 10 mL in 1 vial | 67457-339-50 | Mylan Institutional | 5 December 2013 |
| 10 vial in 1 carton / 20 mL in 1 vial | 67457-340-01 | Mylan Institutional | 5 December 2013 |
| 1 vial in 1 carton / 100 mL in 1 vial | 67457-341-05 | Mylan Institutional | 5 December 2013 |
| 10 vial, single-dose in 1 carton / 15 mL in 1 vial, single-dose | 67457-705-75 | Mylan Institutional | 31 August 2018 |
| 10 vial, single-dose in 1 carton / 25 mL in 1 vial, single-dose | 67457-823-99 | Mylan Institutional | 31 August 2018 |
| 10 vial, single-dose in 1 carton / 30 mL in 1 vial, single-dose | 67457-824-99 | Mylan Institutional | 6 December 2018 |
| 10 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 72078-065-99 | Mylan Institutional | 23 July 2024 |
| 10 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 72078-066-99 | Mylan Institutional | 23 July 2024 |
| 10 vial in 1 carton / 15 mL in 1 vial | 25021-147-20 | Sagent Pharmaceuticals | 1 June 2025 |
| 10 vial in 1 carton / 25 mL in 1 vial | 25021-148-30 | Sagent Pharmaceuticals | 1 June 2025 |
| 10 vial in 1 carton / 30 mL in 1 vial | 25021-149-30 | Sagent Pharmaceuticals | 1 June 2025 |
| 10 vial in 1 carton / 10 mL in 1 vial | 25021-150-10 | Sagent Pharmaceuticals | 15 July 2023 |
| 10 vial in 1 carton / 20 mL in 1 vial | 25021-151-20 | Sagent Pharmaceuticals | 15 July 2023 |
| 1 bottle in 1 carton / 100 mL in 1 bottle | 25021-157-99 | Sagent Pharmaceuticals | 20 September 2012 |
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 15 April 1986 | 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 Vancomycin
Clinical summary
Vancomycin is a glycopeptide antibacterial indicated for the treatment of Clostridioides difficile -associated diarrhea, among other approved uses. It is available as powder for injection, injection and capsules for intravenous, oral and intravitreal use. MedsAcross supplies Vancomycin 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 VancomycinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- vancomycin hydrochloride prescribing information (ANI Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Vancomycin 500 mg/10 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.