Home › NDC Lookup › Ingredients › Milrinone Lactate In 5% Dextrose › 65145-0176-01
Milrinone Lactate in 5% Dextrose .2 mg/mL Injection, Solution — NDC 65145-0176-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Milrinone Lactate in 5% Dextrose .2 mg/mL Injection, Solution — NDC 65145-176-01 (Billing 65145-0176-01)

by Caplin Steriles Limited · 1 BAG in 1 POUCH / 100 mL in 1 BAG

This is a package of Milrinone Lactate in 5% Dextrose .2 mg/mL Injection, Solution from Caplin Steriles Limited, marketed since Jun 2026 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 65145-0176-01
🏷️ FDA NDC (as labeled) 65145-176-01 billing pads the product segment with a zero
This package
Contains100 mL in 1 bag Pack sizes2 compare ↓
Main listing for product 65145-176 · Also comes in: 10 pouches 65145-176-10
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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65145-176-01
Product NDC 65145-176
11-digit billing NDC 65145017601
NCPDP billing unit ML — per mL (volume)
RxCUI 1791840, 1791842
UNII 9K8XR81MO8
UPC 0365145177018, 0365145176011
Application # ANDA219170
SPL Set ID a2822b12-0560-49d6-ace5-2377c04425e8
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 2026-06-25
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 31350050112040
GCN Seq No 064159
GCN 99865
HICL code 009744
Ingredient (HICL) Milrinone Lactate/D5W
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-D5W 20 MG/100 ML
FDB brand name Milrinone In 5% Dextrose
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 064159
  • GCN: 99865
  • GPI-14 (Medi-Span): 31350050112040
  • HICL (First Databank): 009744
  • AHFS class code: 24:04.08.00
  • RxCUI (RxNorm): 1791840
Why two NDCs? The FDA registers this code as 65145-176-01 — 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 → 65145-0176-01. 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-D5W 20 MG/100 ML Ingredient Milrinone Lactate/D5W
📖 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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 10 pouches
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
65145-0176-01 You're viewing this Main listing 1 BAG in 1 POUCH / 100 mL in 1 BAG 2025-09-13 — Active
65145-0176-10 65145-176-10 10 POUCH in 1 CASE / 1 BAG in 1 POUCH / 100 mL in 1 BAG 2026-06-25 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bag in 1 pouch / 100 ml in 1 bag.
What NDC number is used to bill for this package of Milrinone Lactate in 5% Dextrose .2 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 in Dextrose 200 ug/mL 00143-9719-10 Hikma 100 ml — AP FDA listed —
Milrinone Lactate in Dextrose .2 mg/mL 00338-6010-48 Baxter 100 ml — AP FDA listed —
Milrinone Lactate in Dextrose .2 mg/mL 00409-2045-10 Hospira, 10 pouches — AP FDA listed —
Milrinone Lactate in Dextrose .2 mg/mL 25021-0313-82 Sagent 100 ml — AP FDA listed —
Milrinone Lactate .2 mg/mL 55150-0287-10 Eugia 10 pouches — AP FDA listed —
Milrinone Lactate in 5% Dextrose .2 mg/mLthis 65145-0176-01 Caplin 1 pouch — AP FDA listed —
Milrinone Lactate in Dextrose .2 mg/mL 68083-0410-10 Gland 100 ml — AP FDA listed —
Milrinone Lactate in 5% Dextrose .2 mg/mL 70069-0872-10 Somerset 10 pouches — AP FDA listed —
Milrinone Lactate .2 mg/mL 55150-0288-10 Eugia 10 pouches — AP FDA listed —
Milrinone Lactate in 5% Dextrose .2 mg/mL 65145-0177-01 Caplin 1 pouch — AP FDA listed —
Milrinone Lactate in 5% Dextrose .2 mg/mL 70069-0873-10 Somerset 10 pouches — 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

🏛️
2026
On the market since
Jun 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

  • 54.3 mg / 1 mL UNII LX22YL083G
    A simple sugar derived from corn or other sources. It acts as a filler to give the medicine bulk and volume, and as a sweetener to improve taste in oral medications.
  • 0.282 mg / 1 mL 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

LabelerCaplin Steriles Limited
Application holderCAPLIN STERILES LTD
FDA applicationANDA219170 (ANDA)
Labeler code65145
First marketedJun 2026
Product typeHuman Prescription Drug
Portfolio88 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 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 79 words ▾

INDICATIONS AND USAGE Milrinone 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 Lactate in 5% Dextrose Injection 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 Note: Milrinone (200 mcg per mL) in Plastic Container is for intravenous infusion only. Dosage recommendations using a 1 mg per mL concentration of milrinone are included for informational purposes only. 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 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5

6.0The 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 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 9.0 10.1 11.3 12.4 13.5 0.400 3.6 4.8 6.0 7.2 8.4 9.6 10.8 12.0 13.2 14.4 0.500 4.5 6.0 7.5 9.0 10.5 12.0 13.5 15.0 16.5 18.0 0.600 5.4 7.2 9.0 10.8 12.6 14.4 16.2 18.0 19.8 21.6 0.700 6.3 8.4 10.5 12.6 14.7 16.8 18.9 21.0 23.1 25.2 0.750 6.8 9.0 11.3 13.5 15.8 18.0 20.3 22.5 24.8

27.0Dosage 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/1.73m 2 ) Infusion Rate (mcg/kg/min) 5 0.20 10 0.23 20 0.28 30 0.33 40 0.38 50

0.43Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Milrinone Lactate in 5% Dextrose Injection is a clear, colorless to pale yellow solution. DIRECTIONS FOR USE When administering Milrinone Lactate in 5% Dextrose Injection by continuous infusion, it is advisable to use a calibrated electronic infusion device.

To open Tear at the notch and open the overwrap to remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety.

The opacity will diminish gradually. After removing overwrap, check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired.

Preparation for Administration Visually inspect the container. If the administration port is damaged, detached, or not present, discard container as solution path sterility may be impaired. (Use aseptic technique) 1.

Suspend container from eyelet support. 2. Remove top portion of twi… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 27 words ▾

CONTRAINDICATIONS Milrinone is contraindicated in patients who are hypersensitive to it. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

⚠️ 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%. 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.

🔄 Drug Interactions 45 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.

🤰 Pregnancy 113 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 12 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 80 words ▾

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 ~1 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.

📦 How Supplied / Storage and Handling 138 words ▾

HOW SUPPLIED Milrinone Lactate in 5% Dextrose Injection is a clear, colorless to pale yellow solution and is supplied in Infusion bags as follows: NDC No. Milrinone Lactate in 5% Dextrose Injection (200 mcg (0.2 mg) per mL) Pack Style 65145-176-01 20 mg per 100 mL Single-Dose Infusion bag 1 Single-dose Infusion Bag in an Overwrap 65145-177-01 40 mg per 200 mL Single-Dose Infusion bag 1 Single-dose Infusion Bag in an Overwrap Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat.

Protect from freezing. It is recommended that the Flexible Containers be stored at room temperature, 25°C (77°F), however, brief exposure up to 40°C (104°F) does not adversely affect the product. Discard unused portion.

Made in India Distributed By : Caplin Steriles USA Inc, Hamilton, NJ 08619. Code: TN/Drugs/TN00003462 Code: TN/Drugs/TN00006405 July, 2025 22201142 milrinone-caplin-logo

📋 Description 210 words ▾

DESCRIPTION Milrinone lactate 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: Milrinone, USP is a 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 freely soluble in dimethyl sulfoxide; very slightly soluble in methanol, practically insoluble in water and in chloroform.

As the lactate salt, it is stable and colorless to pale yellow in solution. Milrinone is available as sterile aqueous solutions of the lactate salt of milrinone for infusion intravenously. The Flexible containers provide two ready-to-use dilutions of milrinone in volumes of 100 mL and 200 mL of 5% Dextrose Injection.

Each mL contains milrinone lactate equivalent to 200 mcg milrinone. The nominal concentration of lactic acid is 0.282 mg/mL. Each mL also contains 54.3 mg dextrose, hydrous, USP.

The pH is adjusted to between 3.2 and 4.0 with lactic acid and/or sodium hydroxide. The flexible plastic container is comprised of polypropylene with a foil overwrap. Water can permeate the plastic into the overwrap, but the amount is insufficient to significantly affect the premixed solution. milrinone-structure

💬 Information for Patients 39 words ▾

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.

⚠️ 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 163 words ▾

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.

📄 Package Label / Principal Display Panel 132 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 20 mg per 100 mL Bag Label NDC 65145- 176 -01 100 mL Single-Dose Flexible Container Milrinone Lactate in 5% Dextrose Injection 20 mg/100 mL 200 mcg (0.2 mg) per mL 20 mg per 100 mL Pouch Label NDC 65145- 176 -01 100 mL Single-Dose Flexible Container Milrinone Lactate in 5% Dextrose Injection 20 mg/100 mL 200 mcg (0.2 mg) per mL 40 mg per 200 mL Bag Label NDC 65145- 177 -01 200 mL Single-Dose Flexible Container Milrinone Lactate in 5% Dextrose Injection 40 mg/200 mL 200 mcg (0.2 mg) per mL 40 mg per 200 mL Pouch Label NDC 65145- 177 -01 200 mL Single-Dose Flexible Container Milrinone Lactate in 5% Dextrose Injection 40 mg/200 mL 200 mcg (0.2 mg) per mL milrinone-100-ml-bag-label milrinone-100-ml-pouch-label milrinone-200-ml-bag-label milrinone-200-ml-pouch-label

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

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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
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 Caplin Steriles Limited. 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 1 other package presentation of this same product, including 10 pouches (65145-0176-10). 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?
Caplin Steriles Limited 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.
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.
← 65145-0175-10 · Caplin 65145-0177-01 · Caplin →
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.