Prescription drug · ANDA
Milrinone Lactate in Dextrose NDC 0409-1983
Milrinone lactate .2 mg/mL · Injection, Solution · Intravenous · Hospira, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0409-1983-10 | 00409198310 | 10 POUCH in 1 CARTON (0409-1983-10) / 1 BAG in 1 POUCH (0409-1983-01) / 200 mL in 1 BAGMarketed from Oct 4, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 in Dextrose
- Generic name (nonproprietary)
- milrinone lactate in dextrose
- Active ingredients
- Milrinone lactate — .2 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Hospira, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213585
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 3 Inhibitors (Mechanism)
- Identifiers
- Product ID 0409-1983_41afad76-bea1-46c5-ab31-84a54b157410SPL ID 41afad76-bea1-46c5-ab31-84a54b157410SPL set ID 5273ea17-6920-4bff-8c5b-20ea531a0423RxCUI 1791840, 1791842UNII 9K8XR81MO8
- 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
N400409198310followed by a unit qualifier and the quantityPackage 00409-1983-10. 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 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 arrythmias, 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 213585
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 in Dextrose | Milrinone lactate .2 mg/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-2045 |
| Milrinone Lactate in Dextrosemilrinone lactate | Milrinone lactate .2 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-313 |
| Milrinone Lactate in Dextrosemilrinone lactate | Milrinone lactate .2 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-410 |
| Milrinone Lactate in Dextrosemilrinone lactate | Milrinone lactate .2 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-411 |