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Milrinone Lactate 1 mg/mL Injection, Solution — NDC 63323-0617-50 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Milrinone Lactate 1 mg/mL Injection, Solution — NDC 63323-617-50 (Billing 63323-0617-50)

by Fresenius Kabi USA, LLC · 1 VIAL, SINGLE-DOSE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-DOSE

This is a package of Milrinone Lactate 1 mg/mL Injection, Solution from Fresenius Kabi USA, LLC, marketed since Aug 2002 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 63323-0617-50
🏷️ FDA NDC (as labeled) 63323-617-50 billing pads the product segment with a zero
This package
Contains50 mL in 1 vial, single-dose Medicaid pays$0.4254 / unit · 12 mo Per package$21.27 / 50 ml · Medicaid Pack sizes3 compare ↓
Main listing for product 63323-617 · Also comes in: 10 vials 63323-617-10 10 vials 63323-617-20
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 63323-617-50 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
63323 labeler · 617 product · 50 package
Package marketed since
Aug 1, 2002
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0363323617509, 0363323617028, 0363323617011
Medicaid fills, this package
165 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63323-617-50
Product NDC 63323-617
11-digit billing NDC 63323061750
NCPDP billing unit ML — per mL (volume)
RxCUI 1791854, 1791859, 1791861
UNII 9K8XR81MO8
UPC 0363323617509, 0363323617028, 0363323617011
Application # ANDA075936
SPL Set ID ac43ba6b-635d-4129-8eea-96f3f5a4785e
Established class (EPC) Phosphodiesterase 3 Inhibitor
Mechanism of action Phosphodiesterase 3 Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2002-08-01
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance MILRINONE LACTATE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 31350050102030
GPI class Milrinone Lactate
GCN Seq No 017051
GCN 05321
HICL code 006549
Ingredient (HICL) Milrinone Lactate
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A1
Therapeutic class — intermediate (HIC2) Cardiac Stimulants
HIC3 code A1C
Therapeutic class — specific (HIC3) Inotropic Drugs
AHFS code 24:04.08.00
AHFS class Cardiotonic Agents
FDB label name MILRINONE LACT 50 MG/50 ML VL
FDB brand name Milrinone Lactate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 017051
  • GCN: 05321
  • GPI-14 (Medi-Span): 31350050102030
  • HICL (First Databank): 006549
  • AHFS class code: 24:04.08.00
  • RxCUI (RxNorm): 1791854
Why two NDCs? The FDA registers this code as 63323-617-50 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 63323-0617-50. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Phosphodiesterase 3 Inhibitor class.

Pharmacologic class Phosphodiesterase 3 Inhibitor
Drug family (ATC) Phosphodiesterase inhibitors
How it works Phosphodiesterase 3 Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name MILRINONE LACT 50 MG/50 ML VL Ingredient Milrinone Lactate
📗 Our plain-language guide HelloPharmacist
  • It is used for a short time to treat acute decompensated heart failure, which is heart failure that has suddenly worsened. It helps the heart pump better and relaxes blood vessels....
  • A nurse or doctor gives it through an IV, often starting with a slow loading dose followed by a steady infusion. Your team adjusts the rate to how you respond. Treatment is meant t...
  • Some people get headaches, low blood pressure, chest pain or abnormal heart rhythms. That is why you will be watched on a heart monitor. Tell your nurse right away if you feel a ra...
  • Milrinone was used with many heart drugs, diuretics, blood thinners and insulin without problems in limited experience. One exception is furosemide, which should not go through the...
📖 Read our full Milrinone guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $0.4254 $21.27 / 50 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J2260 $1.098 / J2260 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)63323-617-50
11-digit billing NDC63323-0617-50
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ2260
DescriptorINJECTION, MILRINONE LACTATE, 5 MG
Billing units / pkg0.2 units
How the units are derivedThis package is 50 ML; the HCPCS unit is 5 MG, so one package = 0.2 billing units.
Medicare Part B spend (2026 (Q1))$551,123 · 7,266 claims · $75.85 per claim (all NDCs under J2260)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63323-0617-10 63323-617-10 10 VIAL, SINGLE-DOSE in 1 TRAY / 10 mL in 1 VIAL, SINGLE-DOSE 2002-08-01 — Active
63323-0617-20 63323-617-20 10 VIAL, SINGLE-DOSE in 1 TRAY / 20 mL in 1 VIAL, SINGLE-DOSE 2002-08-01 — Active
63323-0617-50 You're viewing this Main listing 1 VIAL, SINGLE-DOSE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-DOSE 2002-08-01 — Active

In Medicaid, this is the most-dispensed pack of this product — about 60% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 vial, single-dose in 1 carton / 50 ml in 1 vial, single-dose.
What NDC number is used to bill for this package of Milrinone Lactate 1 mg/mL Injection, Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Milrinone Lactate 1 mg/mL 00143-9326-10 Hikma 10 vials — AP FDA listed —
Milrinone Lactate 1 mg/mL 70069-0807-10 Somerset 10 vials — AP FDA listed —
Milrinone Lactate 1 mg/mL 70069-0808-10 Somerset 10 vials — AP FDA listed —
Milrinone Lactate 1 mg/mL 70069-0809-01 Somerset 1 vial — AP FDA listed —
Milrinone Lactate 1 mg/mL 71288-0200-11 Meitheal 10 vials — AP FDA listed —
Milrinone Lactate 1 mg/mL 00143-9373-10 Hikma 10 vials — AP FDA listed —
Milrinone Lactate 1 mg/mL 00143-9374-10 Hikma 10 vials — AP FDA listed —
Milrinone Lactate 1 mg/mLthis 63323-0617-50 Fresenius 1 vial — AP FDA listed —
Milrinone Lactate 1 mg/mL 72485-0501-10 Armas 10 vials — AP FDA listed —
Milrinone Lactate 1 mg/mL 72485-0502-10 Armas 10 vials — AP FDA listed —
Milrinone Lactate 1 mg/mL 72485-0503-01 Armas 1 vial — AP FDA listed —
Milrinone Lactate 1 mg/mL 00143-9708-10 Hikma 10 vials — AP FDA listed —
Milrinone Lactate 1 mg/mL 65145-0120-10 Caplin 10 vials — AP FDA listed —
Milrinone Lactate 1 mg/mL 65145-0121-10 Caplin 10 vials — AP FDA listed —
Milrinone Lactate 1 mg/mL 42677-0313-10 Shandong 10 vials — AP FDA listed —
Milrinone Lactate 1 mg/mL 00143-9710-25 Hikma 25 vials — AP FDA listed —
Milrinone Lactate 1 mg/mL 65145-0122-01 Caplin 1 vial — AP FDA listed —
Milrinone Lactate 1 mg/mL 83301-0016-02 Mullan 10 vials — AP FDA listed —
Milrinone Lactate 1 mg/mL 83301-0017-02 Mullan 10 vials — AP FDA listed —
Milrinone Lactate 1 mg/mL 42677-0314-10 Shandong 10 vials — AP FDA listed —
Milrinone Lactate 1 mg/mL 00409-0212-01 Hospira, 10 vials — AP FDA listed —
Milrinone Lactate 1 mg/mL 42677-0338-01 Shandong 1 vial — AP FDA listed —
Milrinone Lactate 1 mg/mL 00143-9709-10 Hikma 20 ml — AP FDA listed —
Milrinone Lactate 1 mg/mL 83301-0018-01 Mullan 1 vial — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2002
On the market since
Aug 2002
📍
2026
Currently FDA-listed
24 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 47 mg / 1 mL UNII 5SL0G7R0OK
    A simple sugar made from corn or other plants, used in medicines as a filler and sweetener. It helps create the right texture and taste in tablets, powders, and liquid formulations.
  • UNII 33X04XA5AT
    Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerFresenius Kabi USA, LLC
Application holderFRESENIUS KABI USA LLC
FDA applicationANDA075936 (ANDA)
Labeler code63323
First marketedAug 2002
Product typeHuman Prescription Drug
Portfolio554 products on file

More NDCs from Fresenius Kabi USA, LLC labeler code 63323

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 81 words ▾

INDICATIONS AND USAGE: Milrinone lactate injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available.

The majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. There is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION: Milrinone should be administered with a loading dose followed by a continuous infusion (maintenance dose) according to the following guidelines: LOADING DOSE 50 mcg/kg: Administer slowly over 10 minutes The table below shows the loading dose in milliliters (mL) of milrinone (1 mg/mL) by patient body weight (kg). Loading Dose (mL) Using 1 mg/mL Concentration Patient Body Weight (kg) kg 30 40 50 60 70 80 90 100 110 120 mL 1.5 2 2.5 3 3.5 4 4.5 5 5.5 6 The loading dose may be given undiluted, but diluting to a rounded total volume of 10 or 20 mL (see Maintenance Dose for diluents) may simplify the visualization of the injection rate.

MAINTENANCE DOSE Infusion Rate Total Daily Dose (24 Hours) Minimum Standard Maximum 0.375 mcg/kg/min 0.50 mcg/kg/min 0.75 mcg/kg/min 0.59 mg/kg 0.77 mg/kg 1.13 mg/kg Administer as a continuous intravenous infusion. Milrinone drawn from vials should be diluted prior to maintenance dose administration. The diluents that may be used are 0.45% Sodium Chloride Injection USP, 0.9% Sodium Chloride Injection USP, or 5% Dextrose Injection USP.

The table below shows the volume of diluent in milliliters (mL) that must be used to achieve 200 mcg/mL concentration for infusion, and the resultant total volumes. Desired Infusion Concentration mcg/mL Milrinone 1 mg/mL (mL) Diluent (mL) Total Volume (mL) 200 10 40 50 200 20 80 100 The infusion rate should be adjusted according to hemodynamic and clinical response. Patients should be closely monitored.

In controlled clinical studies, most patients showed an improvement in hemodynamic status as evidenced by increases in cardiac output and reductions in pulmonary capillary wedge pressure. Note: See Dosage Adjustment in Renally Impaired Patients . Dosage may be titrated to the maximum hemodynamic effect and should not exceed 1.13 mg/kg/day.

Duration of therapy should depend upon patient responsiveness. The maintenance dose in mL/hr by patient body weight (kg) may be determined by reference to the following table. Milrinone Infusion Rate (mL/hr) Using 200 mcg/mL Concentration Maintenance Dose (mcg/kg/min) Patient Body Weight (kg) 30 40 50 60 70 0.375 3.4 4.5 5.6 6.8 7.9 0.400 3.6 4.8 6 7.2 8.4 0.500 4.5 6 7.5 9 10.5 0.600 5.4 7.2 9 10.8 12.6 0.700 6.3 8.4 10.5 12.6 14.7 0.750 6.8 9 11.3 13.5

15.8Maintenance Dose (mcg/kg/min) Patient Body Weight (kg) 80 90 100 110 120 0.375 9 10.1 11.3 12.4 13.5 0.400 9.6 10.8 12 13.2 14.4 0.500 12 13.5 15 16.5 18 0.600 14.4 16.2 18 19.8 21.6 0.700 16.8 18.9 21 23.1 25.2 0.750 18 20.3 22.5 24.8 27 When administering milrinone lactate by continuous infusion, it is advisable to use a calibrated electronic infusion device. Intravenous drug products should be inspected visually and should not be used if particulate matter or discoloration is present. Dosage Adjustment in Renally Impaired Patients Data obtained from patients with severe renal impairment (creatinine clearance = 0 to 30 mL/min) but without congestive heart failure have demonstrated that the presence of renal impairment significantly increases the terminal elimination half-life of milrinone.

Reductions in infusion rate may be necessary in patients with renal impairment. For patients with clinical evidence of renal impairment, the recommended infusion rate can be obtained from the following table: Creatinine Clearance (mL/min/1.73 m 2 ) Infusion Rate (mcg/kg/min) 5 0.20 10 0.23 20 0.28 30 0.33 40 0.38 50

0.43

Dosage Adjustment in Renally Impaired Patients Data obtained from patients with severe renal impairment (creatinine clearance = 0 to 30 mL/min) but without congestive heart failure have demonstrated that the presence of renal impairment significantly increases the terminal elimination half-life of milrinone. Reductions in infusion rate may be necessary in patients with renal impairment. For patients with clinical evidence of renal impairment, the recommended infusion rate can be obtained from the following table: Creatinine Clearance (mL/min/1.73 m… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 13 words ▾

CONTRAINDICATIONS: Milrinone lactate injection is contraindicated in patients who are hypersensitive to it.

⚠️ Warnings 164 words ▾

WARNINGS: Whether given orally or by continuous or intermittent intravenous infusion, milrinone has not been shown to be safe or effective in the longer (greater than 48 hours) treatment of patients with heart failure. In a multicenter trial of 1,088 patients with Class III and IV heart failure, long-term oral treatment with milrinone was associated with no improvement in symptoms and an increased risk of hospitalization and death. In this study, patients with Class IV symptoms appeared to be at particular risk of life-threatening cardiovascular reactions.

There is no evidence that milrinone given by long-term continuous or intermittent infusion does not carry a similar risk. The use of milrinone both intravenously and orally has been associated with increased frequency of ventricular arrhythmias, including nonsustained ventricular tachycardia. Long-term oral use has been associated with an increased risk of sudden death.

Hence, patients receiving milrinone should be observed closely with the use of continuous electrocardiographic monitoring to allow the prompt detection and management of ventricular arrhythmias.

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS: To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Cardiovascular Effects In patients receiving milrinone in Phase II and III clinical trials, ventricular arrhythmias were reported in 12.1%: Ventricular ectopic activity, 8.5%; nonsustained ventricular tachycardia, 2.8%; sustained ventricular tachycardia, 1% and ventricular fibrillation, 0.2% (two patients experienced more than one type of arrhythmia). Holter recordings demonstrated that in some patients injection of milrinone increased ventricular ectopy, including nonsustained ventricular tachycardia.

Life-threatening arrhythmias were infrequent and when present have been associated with certain underlying factors such as preexisting arrhythmias, metabolic abnormalities (e.g. hypokalemia), abnormal digoxin levels and catheter insertion. Milrinone was not shown to be arrhythmogenic in an electrophysiology study. Supraventricular arrhythmias were reported in 3.8% of the patients receiving milrinone.

The incidence of both supraventricular and ventricular arrhythmias has not been related to the dose or plasma milrinone concentration. Other cardiovascular adverse reactions include hypotension, 2.9% and angina/chest pain, 1.2%. In the post-marketing experience, there have been rare cases of “torsades de pointes” reported.

CNS Effects Headaches, usually mild to moderate in severity, have been reported in 2.9% of patients receiving milrinone. Other Effects Other adverse reactions reported, but not definitely related to the administration of milrinone include hypokalemia, 0.6%; tremor, 0.4%; and thrombocytopenia, 0.4%. Isolated spontaneous reports of bronchospasm and anaphylactic shock have been received; and in the post-marketing experience, liver function test abnormalities and skin reactions such as rash have been reported.

Cardiovascular Effects In patients receiving milrinone in Phase II and III clinical trials, ventricular arrhythmias were reported in 12.1%: Ventricular ectopic activity, 8.5%; nonsustained ventricular tachycardia, 2.8%; sustained ventricular tachycardia, 1% and ventricular fibrillation, 0.2% (two patients experienced more than one type of arrhythmia). Holter recordings demonstrated that in some patients injection of milrinone increased ventricular ectopy, including nonsustained ventricular tachycardia. Life-threatening arrhythmias were infrequent and when present have been associated with certain underlying factors such as preexisting arrhythmias, metabolic abnormalities (e.g. hypokalemia), abnormal digoxin levels and catheter insertion.

Milrinone was not shown to be arrhythmogenic in an electrophysiology study. Supraventricular arrhythmias were reported in 3.8% of the patients receiving milrinone. The incidence of both supraventricular and ventricular arrhythmias has not been related to the dose or plasma milrinone concentration.

Other cardiovascular adverse reactions include hypotension, 2.9% and angina/chest pain, 1.2%. In the post-marketing experience, there have been rare cases of “torsades de pointes” reported.

CNS Effects Headaches, usually mild to moderate in severity, have been reported in 2.9% of patients receiving milrinone.

Other Effects Other adverse reactions reported, but not definitely related to the administration of milrinone include hypokalemia, 0.6%; tremor, 0.4%; and thrombocytopenia, 0.4%. Isolated spontaneous reports of bronchospasm and anaphylactic shock have been received; and in the post-marketing experience, liver function test abnormalities and skin reactions such as rash have been reported.

🆘 Overdosage 43 words ▾

OVERDOSAGE: Doses of milrinone may produce hypotension because of its vasodilator effect. If this occurs, administration of milrinone should be reduced or temporarily discontinued until the patient’s condition stabilizes. No specific antidote is known, but general measures for circulatory support should be taken.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY: Milrinone is a positive inotrope and vasodilator, with little chronotropic activity different in structure and mode of action from either the digitalis glycosides or catecholamines. Milrinone, at relevant inotropic and vasorelaxant concentrations, is a selective inhibitor of peak III cAMP phosphodiesterase isozyme in cardiac and vascular muscle. This inhibitory action is consistent with cAMP mediated increases in intracellular ionized calcium and contractile force in cardiac muscle, as well as with cAMP dependent contractile protein phosphorylation and relaxation in vascular muscle.

Additional experimental evidence also indicates that milrinone is not a beta-adrenergic agonist nor does it inhibit sodium-potassium adenosine triphosphatase activity as do the digitalis glycosides. Clinical studies in patients with congestive heart failure have shown that milrinone produces dose-related and plasma drug concentration-related increases in the maximum rate of increase of left ventricular pressure. Studies in normal subjects have shown that milrinone produces increases in the slope of the left ventricular pressure-dimension relationship, indicating a direct inotropic effect of the drug.

Milrinone also produces dose-related and plasma concentration-related increases in forearm blood flow in patients with congestive heart failure, indicating a direct arterial vasodilator activity of the drug. Both the inotropic and vasodilatory effects have been observed over the therapeutic range of plasma milrinone concentrations of 100 ng/mL to 300 ng/mL. In addition to increasing myocardial contractility, milrinone improves diastolic function as evidenced by improvements in left ventricular diastolic relaxation.

The acute administration of intravenous milrinone has also been evaluated in clinical trials in excess of 1,600 patients, with chronic heart failure, heart failure associated with cardiac surgery, and heart failure associated with myocardial infarction. The total number of deaths, either on therapy or shortly thereafter (24 hours) was 15, less than 0.9%, few of which were thought to be drug-related. Pharmacokinetics Following intravenous injections of 12.5 mcg/kg to 125 mcg/kg to congestive heart failure patients, milrinone had a volume of distribution of 0.38 liters/kg, a mean terminal elimination half-life of 2.3 hours, and a clearance of 0.13 liters/kg/hr.

Following intravenous infusions of 0.2 mcg/kg/min to 0.70 mcg/kg/min to congestive heart failure patients, the drug had a volume of distribution of about 0.45 liters/kg, a mean terminal elimination half-life of 2.4 hours, and a clearance of 0.14 liters/kg/hr. These pharmacokinetic parameters were not dose-dependent, and the area under the plasma concentration versus time curve following injections was significantly dose-dependent. Milrinone has been shown (by equilibrium dialysis) to be approximately 70% bound to human plasma protein.

The primary route of excretion of milrinone in man is via the urine. The major urinary excretions of orally administered milrinone in man are milrinone (83%) and its O-glucuronide metabolite (12%). Elimination in normal subjects via the urine is rapid, with approximately 60% recovered within the first 2 hours following dosing and approximately 90% recovered within the first 8 hours following dosing.

The mean renal clearance of milrinone is approximately 0.3 liters/min, indicative of active secretion. Pharmacodynamics In patients with heart failure due to depressed myocardial function, milrinone produced a prompt dose and plasma concentration related increase in cardiac output and decreases in pulmonary capillary wedge pressure and vascular resistance, which were accompanied by mild-to-moderate increases in heart rate. Additionally, there is no increased effect on myocardial oxygen consumption.

In uncontrolled studies, hemodynamic improvement during intravenous therapy with milrinone was accompanied by clinical symptomatic improvement… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 106 words ▾

HOW SUPPLIED: Milrinone Lactate Injection is supplied as follows: Product Code Unit of Sale Strength Each 601710 NDC 63323-617-10 Unit of 10 10 mg per 10 mL (1 mg per mL) NDC 63323-617-01 10 mL Single Dose Vial 601720 NDC 63323-617-20 Unit of 10 20 mg per 20 mL (1 mg per mL) NDC 63323-617-02 20 mL Single Dose Vial 601750 NDC 63323-617-50 Individually packaged 50 mg per 50 mL (1 mg per mL) NDC 63323-617-50 50 mL Single Dose Vial This container closure is not made with natural rubber latex. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Avoid freezing.

📋 Description 177 words ▾

DESCRIPTION: Milrinone lactate injection is a member of a new class of bipyridine inotropic/vasodilator agents with phosphodiesterase inhibitor activity, distinct from digitalis glycosides or catecholamines. Milrinone lactate is designated chemically as 1,6-dihydro-2-methyl-6-oxo-[3,4'-bipyridine]-5-carbonitrile lactate and has the following structure: C 12 H 9 N 3 O M.W. 211.2 Milrinone is an off-white to tan crystalline compound.

It is slightly soluble in methanol, and very slightly soluble in chloroform and in water. As the lactate salt, it is stable and colorless to pale yellow in solution. Milrinone lactate injection is available as sterile aqueous solutions of the lactate salt of milrinone for injection or infusion intravenously.

Sterile, single-dose vials of 10, 20, and 50 mL contain in each mL milrinone lactate equivalent to 1 mg milrinone and 47 mg Dextrose, Anhydrous, USP, in Water for Injection, USP. The pH is adjusted to between 3.2 and 4.0 with lactic acid or sodium hydroxide. The total concentration of lactic acid can vary between 0.95 mg/mL and 1.29 mg/mL.

These vials require preparation of dilutions prior to administration to patients intravenously. milrinone

⚠️ Precautions ~3 min read ▾

PRECAUTIONS: General Milrinone should not be used in patients with severe obstructive aortic or pulmonic valvular disease in lieu of surgical relief of the obstruction. Like other inotropic agents, it may aggravate outflow tract obstruction in hypertrophic subaortic stenosis. Supraventricular and ventricular arrhythmias have been observed in the high-risk population treated.

In some patients, injections of milrinone and oral milrinone have been shown to increase ventricular ectopy, including nonsustained ventricular tachycardia. The potential for arrhythmia, present in congestive heart failure itself, may be increased by many drugs or combinations of drugs. Patients receiving milrinone should be closely monitored during infusion.

Milrinone produces a slight shortening of AV node conduction time, indicating a potential for an increased ventricular response rate in patients with atrial flutter/fibrillation which is not controlled with digitalis therapy. During therapy with milrinone blood pressure and heart rate should be monitored and the rate of infusion slowed or stopped in patients showing excessive decreases in blood pressure. If prior vigorous diuretic therapy is suspected to have caused significant decreases in cardiac filling pressure, milrinone should be cautiously administered with monitoring of blood pressure, heart rate, and clinical symptomatology.

Use in Acute Myocardial Infarction No clinical studies have been conducted in patients in the acute phase of post myocardial infarction. Until further clinical experience with this class of drugs is gained, milrinone is not recommended in these patients. Laboratory Tests Fluid and Electrolytes: Fluid and electrolyte changes and renal function should be carefully monitored during therapy with milrinone.

Improvement in cardiac output with resultant diuresis may necessitate a reduction in the dose of diuretic. Potassium loss due to excessive diuresis may predispose digitalized patients to arrhythmias. Therefore, hypokalemia should be corrected by potassium supplementation in advance of or during use of milrinone.

Drug Interactions No untoward clinical manifestations have been observed in limited experience with patients in whom milrinone was used concurrently with the following drugs: digitalis glycosides; lidocaine, quinidine; hydralazine, prazosin; isosorbide dinitrate, nitroglycerin; chlorthalidone, furosemide, hydrochlorothiazide, spironolactone; captopril; heparin, warfarin, diazepam, insulin; and potassium supplements. Chemical Interactions There is an immediate chemical interaction which is evidenced by the formation of a precipitate when furosemide is injected into an intravenous line of an infusion of milrinone.

Therefore, furosemide should not be administered in intravenous lines containing milrinone. Carcinogenesis, Mutagenesis, Impairment of Fertility Twenty-four months of oral administration of milrinone to mice at doses up to 40 mg/kg/day (about 50 times the human oral therapeutic dose in a 50 kg patient) was unassociated with evidence of carcinogenic potential. Neither was there evidence of carcinogenic potential when milrinone was orally administered to rats at doses up to 5 mg/kg/day (about six times the human oral therapeutic dose) for 24 months or at 25 mg/kg/day (about 30 times the human oral therapeutic dose) for up to 18 months in males and 20 months in females.

Whereas the Chinese Hamster Ovary Chromosome Aberration Assay was positive in the presence of a metabolic activation system, results from the Ames Test, the Mouse Lymphoma Assay, the Micronucleus Test, and the in vivo Rat Bone Marrow Metaphase Analysis indicated an absence of mutagenic potential. In reproductive performance studies in rats, milrinone had no effect on male or female fertility at oral doses up to 32 mg/kg/day. Animal Toxicity Oral and intravenous administration of toxic dosages of milrinone to rats and dogs resulted in myocardial degeneration/fibrosis and endocardial hemorrhage, p… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel ~1 min read ▾

PACKAGE LABEL - PRINCIPAL DISPLAY - Milrinone 10 mL Single Dose Vial Label NDC 63323-617-01 601710 Milrinone Lactate Injection 10 mg per 10 mL (1 mg per mL)* For Intravenous Use Only Rx only 10 mL Single Dose Vial vial

PACKAGE LABEL - PRINCIPAL DISPLAY - Milrinone 10 mL Single Dose Vial Tray Label NDC 63323-617-10 601710 Milrinone Lactate Injection 10 mg per 10 mL (1 mg per mL)* For Intravenous Use Only 10 mL Single Dose Vial 10 Vials Rx only tray

PACKAGE LABEL - PRINCIPAL DISPLAY – Milrinone Lactate 20 mL Single Dose Vial Label NDC 63323-617-02 601720 Milrinone Lactate Injection 20 mg per 20 mL (1 mg per mL) For Intravenous Use Only Rx only 20 mL Single Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY – Milrinone Lactate 20 mL Single Dose Vial Label

PACKAGE LABEL - PRINCIPAL DISPLAY - Milrinone Lactate 20 mL Tray Label NDC 63323-617- 20 601720 Milrinone Lactate Injection 20 mg per 20 mL (1 mg per mL) For Intravenous Use Only 20 mL Single Dose Vial 10 Vials Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Milrinone Lactate 20 mL Tray Label

PACKAGE LABEL - PRINCIPAL DISPLAY – Milrinone Lactate 50 mL Single Dose Vial Label NDC 63323-617-50 601750 MILRINONE LACTATE INJECTION 50 mg per 50 mL (1 mg per mL)* For Intravenous Use Only Rx Only 50 mL Single Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY – Milrinone Lactate 50 mL Single Dose

PACKAGE LABEL - PRINCIPAL DISPLAY - Milrinone Lactate 50 mL Single Dose Vial Carton NDC 63323-617-50 601750 MILRINONE LACTATE INJECTION 50 mg per 50 mL (1 mg per mL)* For Intravenous Use Only 50 mL Single Dose Vial Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Milrinone Lactate 50 mL Single Dose Vial Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
165
Units reimbursed last 4 qtrs
33K
Gross reimbursed last 4 qtrs
$14K
Avg / prescription
$85.00
Avg / unit
$0.4254
Latest quarter Q1 2026
44Rx
Fee-for-service vs managed care ⓘ
56% FFS 44% MCO
Fee-for-service · 93 Rx Managed care · 72 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: 1,814 units · 232 per 100k residents ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 11,984 units · 61.2 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 15,675 units · 121 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 3,495 units · 15.5 per 100k residents FL
Units reimbursed · per 100k residents
15.5232
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 North Dakota 232 /100k
2 Pennsylvania 121 /100k
3 New York 61.2 /100k
4 Florida 15.5 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 vial this page63323-0617-50 165 Rx · $14,025
10 vials63323-0617-10 109 Rx · $710
10 vials63323-0617-20 No Medicaid data
Drug total (last 4 qtrs): 274 Rx · 35,278 units · $14,735 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Milrinone Lactate — the program that covers self-administered drugs. 3 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Milrinone Lactate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$9K
Claims incl. refills
89
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$100.84
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Fresenius Kabi USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 10 vials (63323-0617-10), 10 vials (63323-0617-20). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Fresenius Kabi USA, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J2260 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 63323-0616-03 · Fresenius 63323-0621-00 · Fresenius →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.