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Milrinone Lactate 1 mg/mL Injection, Solution — NDC 72485-0502-10 package photo
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Milrinone Lactate 1 mg/mL Injection, Solution — NDC 72485-502-10 (Billing 72485-0502-10)

by Armas Pharmaceuticals Inc. · 10 VIAL in 1 CARTON / 20 mL in 1 VIAL

This is a package of Milrinone Lactate 1 mg/mL Injection, Solution from Armas Pharmaceuticals Inc., marketed since Apr 2023 and currently FDA-listed. It is this product's only package size.

NDC 72485-0502-10
🏷️ FDA NDC (as labeled) 72485-502-10 billing pads the product segment with a zero
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

Past resolved recalls for this product (1)
Class III · Aug 14, 2023 · Terminated — Failed Impurities/Degradation Specifications (Caplin Steriles Limited) · FDA recall D-1144-2023

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72485-502-10
Product NDC 72485-502
11-digit billing NDC 72485050210
NCPDP billing unit ML — per mL (volume)
RxCUI 1791854, 1791859, 1791861
UNII 9K8XR81MO8
UPC 0372485503018, 0372485501014, 0372485502011, 0372485502103
Application # ANDA214380
SPL Set ID fde1e354-4f15-4ade-9ae3-db2ba67e0431
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 2023-04-05
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 31350050102040
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 20 MG/20 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): 31350050102040
  • HICL (First Databank): 006549
  • AHFS class code: 24:04.08.00
  • RxCUI (RxNorm): 1791854
Why two NDCs? The FDA registers this code as 72485-502-10 — 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 → 72485-0502-10. 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 20 MG/20 ML VL Ingredient Milrinone Lactate
📖 What it is MedlinePlus · NLM

Milrinone injection is used to treat heart failure. Milrinone is in a class of medications called cardiotonic agents. It works by helping the heart to pump better.

Read the full MedlinePlus article ↗
📗 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 No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
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)72485-502-10
11-digit billing NDC72485-0502-10
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 20 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
72485-0502-10 You're viewing this Main listing 10 VIAL in 1 CARTON / 20 mL in 1 VIAL 2023-04-05 — Active

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 00143-9374-10 Hikma 10 vials — AP FDA listed —
Milrinone Lactate 1 mg/mL 00143-9709-10 Hikma 20 ml — AP FDA listed —
Milrinone Lactate 1 mg/mL 00409-0212-01 Hospira, 10 vials — AP FDA listed —
Milrinone Lactate 1 mg/mL 42677-0314-10 Shandong 10 vials — AP FDA listed —
Milrinone Lactate 1 mg/mL 63323-0617-10 Fresenius 10 vials — AP FDA listed —
Milrinone Lactate 1 mg/mL 65145-0121-10 Caplin 10 vials — AP FDA listed —
Milrinone Lactate 1 mg/mL 70069-0808-10 Somerset 10 vials — AP FDA listed —
Milrinone Lactate 1 mg/mL 71288-0200-11 Meitheal 10 vials — AP FDA listed —
Milrinone Lactate 1 mg/mLthis 72485-0502-10 Armas 10 vials — AP FDA listed —
Milrinone Lactate 1 mg/mL 83301-0017-02 Mullan 10 vials — AP FDA listed —
Milrinone Lactate 1 mg/mL 70069-0807-10 Somerset 10 vials — AP FDA listed —
Milrinone Lactate 1 mg/mL 70069-0809-01 Somerset 1 vial — AP FDA listed —
Milrinone Lactate 1 mg/mL 00143-9373-10 Hikma 10 vials — AP FDA listed —
Milrinone Lactate 1 mg/mL 72485-0501-10 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 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 42677-0338-01 Shandong 1 vial — 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

🏛️
2023
On the market since
Apr 2023
📍
2026
Currently FDA-listed
3 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.

  • 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.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

4 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

LabelerArmas Pharmaceuticals Inc.
Application holderCAPLIN STERILES LTD
FDA applicationANDA214380 (ANDA)
Labeler code72485
First marketedApr 2023
Product typeHuman Prescription Drug
Portfolio61 products on file
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 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 81 words ▾

INDICATIONS & 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 A loading dose of Milrinone Lactate Injection ( 1 mg [base]/mL ) should be administered 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). Loa ding 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 Maintenance Dose Infusion Rate Total Daily Dose (24 hours) Administer as a continuous intravenous infusion Minimum 0.375 mcg/kg/min 0.59 mg/kg Standard 0.5 mcg/kg/min 0.77 mg/kg Maximum 0.75 mcg/kg/min 1.13 mg/kg 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 80 90 100 110 120 0.375 3.4 4.5 5.6 6.8 7.9 9 10.1 11.3 12.4 13.5 0.4 3.6 4.8 6 7.2 8.4 9.6 10.8 12 13.2 14.4 0.5 4.5 6 7.5 9 10.5 12 13.5 15 16.5 18 0.6 5.4 7.2 9 10.8 12.6 14.4 16.2 18 19.8 21.6 0.7 6.3 8.4 10.5 12.6 14.7 16.8 18.9 21 23.1 25.2 0.75 6.8 9 11.3 13.5 15.8 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 0.2 10 0.23 20 0.28 30 0.33 40 0.38 50 0.43

⛔ 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 1088 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 ~1 min read ▾

ADVERSE REACTIONS 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% (2 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.

Post-Marketing Adverse Event Reports In addition to adverse events reported from clinical trials, the following events have been reported from worldwide post-marketing experience with milrinone: Isolated spontaneous reports of bronchospasm and anaphylactic shock. Liver function test abnormalities and skin reactions such as rash. Administration site conditions: Infusion site reaction.

To report SUSPECTED ADVERSE REACTIONS, contact Caplin Steriles Limited at 1-866-978-6111 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 86 words ▾

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.

🤰 Pregnancy 112 words ▾

Pregnancy Oral administration of milrinone to pregnant rats and rabbits during organogenesis produced no evidence of teratogenicity at dose levels up to 40 mg/kg/day and 12 mg/kg/day, respectively. Milrinone did not appear to be teratogenic when administered intravenously to pregnant rats at doses up to 3 mg/kg/day (about 2.5 times the maximum recommended clinical intravenous dose) or pregnant rabbits at doses up to 12 mg/kg/day, although an increased resorption rate was apparent at both 8 mg/kg/day and 12 mg/kg/day (intravenous) in the latter species.

There are no adequate and well-controlled studies in pregnant women. Milrinone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 92 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established. Use in Elderly Patients There are no special dosage recommendations for the elderly patient. Ninety percent of all patients administered milrinone in clinical studies were within the age range of 45 to 70 years, with a mean age of 61 years.

Patients in all age groups demonstrated clinically and statistically significant responses. No age-related effects on the incidence of adverse reactions have been observed. Controlled pharmacokinetic studies have not disclosed any age-related effects on the distribution and elimination of milrinone.

🆘 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 1600 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 0.7 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 0-glucuronide metabolite (12%). Elimination in normal subjects via the urine is rapid, with approximately 60% recovered within the first two hours following dosing and approximately 90% recovered within the first eight 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 improveme… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 142 words ▾

HOW SUPPLIED Milrinone Lactate Injection USP, is a sterile, clear, colorless to pale yellow solution. Each mL contains milrinone lactate equivalent to 1 mg milrinone. Supplied in single-dose vials as follows: NDC No.

Strength How Supplied NDC 72485-501-10 10 mg/10 mL (1 mg/mL) 10 mL Single-dose vials, in packages of 10. NDC 72485-502-10 20 mg/20 mL (1 mg/mL) 20 mL Single dose vials, in packages of 10. NDC 72485-503-01 50 mg/50 mL (1 mg/mL) 50 mL Single dose vial, packaged individually.

Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing. Exposure of pharmaceutical products to heat should be minimized.

Avoid excessive heat. Protect from freezing. Discard unused portion.

Distributed by: Armas Pharmaceuticals, Inc., Freehold, NJ 07728 (USA) Manufactured by: Caplin Steriles Limited, Gummidipoondi - 601 201, India. Made in India September, 2022 Code: TN/Drugs/TN00003457 22200454

📋 Description 188 words ▾

DESCRIPTION Milrinone Lactate Injection is a member of a 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: Milrinone is an off-white to tan crystalline compound with a molecular weight of 211.2 and a molecular formula of C 12 H 9 N 3 O. 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 is available as sterile aqueous solutions of the lactate salt of milrinone for injection or infusion intravenously. Sterile, Single Dose Vials: 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-spl-structure

⚠️ 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.

There is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours. Cases of infusion site reaction have been reported with intravenous milrinone therapy (see ADVERSE REACTIONS ). Consequently, careful monitoring of the infusion site should be maintained to avoid possible extravasation.

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 6 times the human oral therapeutic dose) for twenty-four 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 absen… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 25 words ▾

Nursing Mothers Caution should be exercised when milrinone is administered to nursing women, since it is not known whether it is excreted in human milk.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

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 6 times the human oral therapeutic dose) for twenty-four 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, principally affecting the left ventricular papillary muscles.

Coronary vascular lesions characterized by periarterial edema and inflammation have been observed in dogs only. The myocardial/endocardial changes are similar to those produced by beta-adrenergic receptor agonists such as isoproterenol, while the vascular changes are similar to those produced by minoxidil and hydralazine. Doses within the recommended clinical dose range (up to 1.13 mg/kg/day) for congestive heart failure patients have not produced significant adverse effects in animals.

📄 Package Label / Principal Display Panel 199 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Milrinone Lactate Injection - 10 mL Vial Label NDC 72485- 501 -01 Rx Only Milrinone Lactate Injection, USP 10 mg/10 mL (1 mg/mL) For Intravenous Use Only 10 mL Single-Dose Vial Milrinone Lactate Injection - 10 mL Carton Rx Only NDC 72485- 501 -10 10 x 10 mL Single-Dose Vials Milrinone Lactate Injection, USP 10 mg/10 mL (1 mg/mL) For Intravenous Use Only Milrinone Lactate Injection - 20 mL Vial Label NDC 72485- 502 -01 Rx Only Milrinone Lactate Injection, USP 20 mg/20 mL (1 mg/mL) For Intravenous Use Only 20 mL Single-Dose Vial Milrinone Lactate Injection - 20 mL Carton Rx Only NDC 72485- 502 -10 10 x 20 mL Single-Dose Vials Milrinone Lactate Injection, USP 20 mg/20 mL (1 mg/mL) For Intravenous Use Only Milrinone Lactate Injection - 50 mL Vial Label NDC 72485- 503 -01 Rx Only Milrinone Lactate Injection, USP 50 mg/50 mL (1 mg/mL) For Intravenous Use Only 50 mL Single-Dose Vial Milrinone Lactate Injection - 50 mL Carton Rx Only NDC 72485- 503 -01 Milrinone Lactate Injection, USP 50 mg/50 mL (1 mg/mL) For Intravenous Use Only 1 x 50 mL Single-Dose Vial milrinone-lactate-inj-vial-10ml milrinone-lactate-inj-carton-10ml milrinone-lactate-inj-vial-20ml milrinone-lactate-inj-carton-20ml milrinone-lactate-inj-vial-50ml milrinone-lactate-inj-carton-50ml

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

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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 Armas Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Armas Pharmaceuticals Inc. 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.
← 72485-0501-10 · Armas 72485-0503-01 · Armas →
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.