Active ingredient
Milrinone
39 finished FDA listings contain Milrinone as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- MILRINONE, MILRINONE LACTATE
- Dosage forms
- Injection, Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 13
- Strengths listed
- .2 mg/ml · 1 mg/ml · 200 ug/ml
- Brand names in FDA listings
- Milrinone Lactate, Milrinone Lactate In Dextrose
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 52769
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 075936 | FRESENIUS KABI USA | 2002-05-28 | 1 |
| ANDA 075834 | BAXTER HLTHCARE | 2002-05-28 | 2 |
| ANDA 090038 | HIKMA FARMACEUTICA | 2010-01-21 | 2 |
| ANDA 077966 | HIKMA FARMACEUTICA | 2010-12-03 | 6 |
| ANDA 203280 | HOSPIRA | 2014-09-03 | 1 |
| ANDA 211671 | MEITHEAL | 2020-03-24 | 1 |
| ANDA 213585 | GLAND | 2020-07-16 | 5 |
| ANDA 209666 | EUGIA PHARMA | 2020-09-03 | 2 |
| ANDA 214380 | CAPLIN | 2021-04-16 | 9 |
| ANDA 216373 | SHANDONG | 2023-01-23 | 6 |
| ANDA 219170 | CAPLIN | 2025-09-02 | 4 |
Official labeling on DailyMed
- MILRINONE LACTATE INJECTION, SOLUTION [MULLAN PHARMACEUTICAL INC.] · version 5 · 2026-08-20
- MILRINONE LACTATE IN 5% DEXTROSE INJECTION, SOLUTION [CAPLIN STERILES LIMITED] · version 2 · 2026-06-26
- MILRINONE LACTATE INJECTION, SOLUTION [SHANDONG NEW TIME PHARMACEUTICAL CO., LTD.] · version 6 · 2026-06-15
- MILRINONE LACTATE IN DEXTROSE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 8 · 2026-05-20
- MILRINONE LACTATE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 22 · 2026-05-11
- MILRINONE LACTATE IN DEXTROSE (MILRINONE LACTATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] · version 16 · 2026-04-06
- MILRINONE LACTATE IN 5% DEXTROSE INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC] · version 1 · 2026-03-26
- MILRINONE LACTATE INJECTION, SOLUTION [HOSPIRA, INC.] · version 7 · 2025-10-02
- MILRINONE LACTATE INJECTION, SOLUTION [CAPLIN STERILES LIMITED] · version 5 · 2025-02-17
- MILRINONE LACTATE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 3 · 2023-11-21
- MILRINONE LACTATE (MILRINONE LACTATE IN 5% DEXTROSE) INJECTION, SOLUTION [EUGIA US LLC] · version 5 · 2023-06-21
- MILRINONE LACTATE INJECTION, SOLUTION [ARMAS PHARMACEUTICALS INC.] · version 1 · 2023-04-06
Showing the 12 most recent of 19 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.