Prescription drug · ANDA
Milrinone Lactate NDC 42677-313
Milrinone lactate 1 mg/mL · Injection, Solution · Intravenous · Shandong New Time Pharmaceutical Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42677-313-10 | 42677031310 | 10 VIAL in 1 CARTON (42677-313-10) / 10 mL in 1 VIAL (42677-313-01)Marketed from Jan 23, 2023 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216373
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 3 Inhibitors (Mechanism)
- Identifiers
- Product ID 42677-313_541eb7f5-0e0f-03ab-e063-6294a90a86e9SPL ID 541eb7f5-0e0f-03ab-e063-6294a90a86e9SPL set ID 0fdaee3c-2144-4ca7-9868-54d251f468c0RxCUI 1791854, 1791859, 1791861UNII 9K8XR81MO8UPC 0342677338018, 0342677314012
- 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
N442677031310followed by a unit qualifier and the quantityPackage 42677-0313-10. 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 AND USAGE Milrinone Lactate Injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone lactate 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 lactate has been in patients receiving digoxin and diuretics.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216373
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 | Mullan Pharmaceutical Inc. | 83301-0016 |
| Milrinone Lactate | Milrinone lactate 1 mg/mL | Injection, SolutionIntravenous | Mullan Pharmaceutical Inc. | 83301-0017 |
| Milrinone Lactate | Milrinone lactate 1 mg/mL | Injection, SolutionIntravenous | Mullan Pharmaceutical Inc. | 83301-0018 |
| Milrinone Lactate | Milrinone lactate 1 mg/mL | Injection, SolutionIntravenous | Shandong New Time Pharmaceutical Co., Ltd. | 42677-314 |
| Milrinone Lactate | Milrinone lactate 1 mg/mL | Injection, SolutionIntravenous | Shandong New Time Pharmaceutical Co., Ltd. | 42677-338 |