Medicine
Milrinone 50 mg/50 mL injection
Milrinone 50 mg/50 mL injection is a generic prescription medicine for intravenous use, made by 7 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
Avoid freezing. Protect from freezing. Store at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Milrinone
- Brand
- Sold under the generic name
- Strength
- 50 mg/50 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 50 mL, 10 vials of 50 mL and 5 more
- Manufacturers
- Caplin SterilesIndiaShandong New Time PharmaceuticalArmas PharmaceuticalsFresenius KabiHospiraMeitheal PharmaceuticalsSomerset Therapeutics
- Origin register
- US FDA, United States
- Storage
- Avoid freezing. Protect from freezing. Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C01CE02 Milrinone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 August 2002
- Identifiers
- RxCUI 1791854, 1791859, 1791861DailyMed set ID cbe097f8-9599-4f5b-bdf3-3f43d3e3461b, 813e8ca2-de54-4a7c-a2d2-8bd44396c341, fde1e354-4f15-4ade-9ae3-db2ba67e0431 +4NDC 65145-122, 0409-0212, 72485-503 +4Application ANDA214380, ANDA203280, ANDA211671 +2
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 / 50 mL in 1 vial | 65145-122-01 | Caplin SterilesIndia | 14 February 2025 |
| 1 vial in 1 carton / 50 mL in 1 vial | 72485-503-01 | Armas Pharmaceuticals | 5 April 2023 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 63323-617-50 | Fresenius Kabi | 1 August 2002 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 0409-0212-03 | Hospira | 31 March 2015 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 71288-200-50 | Meitheal Pharmaceuticals | 24 March 2020 |
| 1 vial in 1 carton / 50 mL in 1 vial | 42677-338-01 | Shandong New Time Pharmaceutical | 5 June 2025 |
| 10 vial in 1 carton / 50 mL in 1 vial | 42677-338-10 | Shandong New Time Pharmaceutical | 5 June 2025 |
| 1 vial in 1 carton / 50 mL in 1 vial | 70069-809-01 | Somerset Therapeutics | 23 September 2022 |
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 31 December 1987 | 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 Milrinone
Clinical summary
Milrinone is a phosphodiesterase 3 inhibitor indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. It is available as injection for intravenous use. MedsAcross supplies Milrinone 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 MilrinoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Milrinone Lactate prescribing information (Mullan Pharmaceutical) · U.S. National Library of Medicine, DailyMed
Need Milrinone 50 mg/50 mL 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.