Prescription drug · ANDA
Milrinone Lactate NDC 65145-120
Milrinone lactate 1 mg/mL · Injection, Solution · Intravenous · Caplin Steriles Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65145-120-10 | 65145012010 | 10 VIAL in 1 CARTON (65145-120-10) / 10 mL in 1 VIAL (65145-120-01)Marketed from Feb 14, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Milrinone Lactate
- Generic name (nonproprietary)
- milrinone lactate
- Active ingredients
- Milrinone lactate — 1 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Caplin Steriles Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214380
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 3 Inhibitors (Mechanism)
- Identifiers
- Product ID 65145-120_0de424df-9ffa-4223-9850-9d644c803825SPL ID 0de424df-9ffa-4223-9850-9d644c803825SPL set ID cbe097f8-9599-4f5b-bdf3-3f43d3e3461bRxCUI 1791854, 1791859, 1791861UNII 9K8XR81MO8UPC 0365145120106, 0365145120014, 0365145121011, 0365145122018, 0365145121103
- Pharmacologic class
- Phosphodiesterase 3 Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N465145012010followed by a unit qualifier and the quantityPackage 65145-0120-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
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.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214380
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Milrinone Lactate | Milrinone lactate 1 mg/mL | Injection, SolutionIntravenous | Caplin Steriles Limited | 65145-122 |
| Milrinone Lactate | Milrinone lactate 1 mg/mL | Injection, SolutionIntravenous | Caplin Steriles Limited | 65145-121 |
| Milrinone Lactate | Milrinone lactate 1 mg/mL | Injection, SolutionIntravenous | Somerset Therapeutics, LLC | 70069-807 |
| Milrinone Lactate | Milrinone lactate 1 mg/mL | Injection, SolutionIntravenous | Somerset Therapeutics, LLC | 70069-808 |
| Milrinone Lactate | Milrinone lactate 1 mg/mL | Injection, SolutionIntravenous | Somerset Therapeutics, LLC | 70069-809 |
| Milrinone Lactate | Milrinone lactate 1 mg/mL | Injection, SolutionIntravenous | Armas Pharmaceuticals Inc. | 72485-502 |
| Milrinone Lactate | Milrinone lactate 1 mg/mL | Injection, SolutionIntravenous | Armas Pharmaceuticals Inc. | 72485-501 |
| Milrinone Lactate | Milrinone lactate 1 mg/mL | Injection, SolutionIntravenous | Armas Pharmaceuticals Inc. | 72485-503 |