Milrinone Lactate Injection, Solution
NDC Package 65145-121-10

11-digit billing NDC: 65145012110 · Billing unit: ML · 200 ML per package
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Milrinone Lactate injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. This formulation utilizes a injection, solution delivery system. Marketed by Caplin Steriles Limited, this product is identified by NDC 65145-121 and is authorized under FDA application ANDA214380.

Identification & Billing

NDC Package Code
65145-121-10
Package Description
10 VIAL in 1 CARTON / 20 mL in 1 VIAL (65145-121-01)
Product Code
65145-121
11-Digit Billing Format
65145012110
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
200 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Milrinone Lactate
Non-Proprietary Name
Milrinone Lactate
Substance Name
Milrinone Lactate
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
MILRINONE LACTATE 1 mg/mL
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Caplin Steriles Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA214380
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-14-2025
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J2260
Source: ASP
Inj milrinone lactate / 5 mg
HCPCS Dosage 5 MG
Units / Pkg 40

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 65145-121-10 identifies a specific commercial package of 10 vial in 1 carton / 20 ml in 1 vial (65145-121-01) of Milrinone Lactate, a human prescription drug labeled by Caplin Steriles Limited. This product is billed per "ML" milliliter and contains an estimated amount of 200 billable units per package. This injection, solution is formulated for intravenous use and contains milrinone lactate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Caplin Steriles Limited on February 14, 2025. The current certification is valid through December 31, 2027.

How is this Caplin Steriles Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65145012110. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 200 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
65145-121-10
11-Digit CMS (5-4-2)
65145-0121-10

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.