Medicine
Polymyxin b 500000 units powder for injection
Polymyxin b 500000 units powder for injection is a generic prescription medicine for intramuscular, intrathecal, intravenous use, made by 2 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 at 20° to 25°C (68° to 77°F). Protect from light. After Reconstitution…
Key facts
- Active ingredient (INN)
- Polymyxin b
- Brand
- Sold under the generic name
- Strength
- 500000 units
- Dosage form
- Powder for injection
- Route
- Intramuscular, intrathecal, intravenous
- Packs
- 10 vials
- Manufacturers
- Fresenius KabiSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from light. After Reconstitution: Product must be stored under refrigeration, between 2° and 8°C (36° and 46°F), and any unused portion should be discarded after 72 hours.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 9 September 2015
- Identifiers
- RxCUI 204509DailyMed set ID 7dc505aa-64b0-4b7f-8ee3-2945bde40a34, 72dd6de6-31d6-4a8f-881b-91af91ed9314NDC 25021-196, 63323-367Application ANDA207322, ANDA202766
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 |
|---|---|---|---|
| 10 vial, glass in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, glass | 63323-367-44 | Fresenius Kabi | 9 September 2015 |
| 10 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial | 25021-196-10 | Sagent Pharmaceuticals | 1 October 2025 |
| 10 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial | 55150-234-10 | — | 4 April 2016 |
| 10 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial | 68083-174-10 | — | 1 June 2016 |
| 10 vial in 1 tray / 1 injection, powder, lyophilized, for solution in 1 vial | 63323-321-10 | — | 17 November 2009 |
| 10 vial in 1 tray / 1 injection, powder, lyophilized, for solution in 1 vial | 63323-321-12 | — | 17 November 2009 |
| 1 vial, glass in 1 carton / 1 injection, powder, for solution in 1 vial, glass | 0143-9461-01 | — | 30 September 2025 |
| 10 vial, glass in 1 carton / 1 injection, powder, for solution in 1 vial, glass | 0143-9461-10 | — | 30 September 2025 |
| 10 vial in 1 carton / 1 injection, powder, for solution in 1 vial | 0143-9941-10 | — | 1 June 1998 |
| 10 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial | 72266-249-10 | — | 31 August 2023 |
| 1 vial, glass in 1 carton / 1 injection, powder, for solution in 1 vial, glass | 70594-049-01 | — | 1 October 2018 |
| 10 vial, glass in 1 carton / 1 injection, powder, for solution in 1 vial, glass | 70594-049-02 | — | 1 October 2018 |
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 | Approved | 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
Alternatives
Other makers and brands of Polymyxin b 500000 units powder for injection.
Clinical summary
Polymyxin b is a polymyxin-class antibacterial indicated in serious infections caused by susceptible strains of organisms, when less potentially toxic drugs are ineffective or contraindicated. MedsAcross supplies Polymyxin b 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 Polymyxin bFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Polymyxin B prescribing information (Xellia Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
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