Prescription drug · ANDA
Milrinone Lactate in Dextrose (milrinone lactate) NDC 68083-410
Milrinone lactate .2 mg/mL · Injection, Solution · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-410-10 | 68083041010 | 10 CARTON in 1 CARTON (68083-410-10) / 1 BAG in 1 CARTON (68083-410-01) / 100 mL in 1 BAGMarketed from Jul 16, 2020 |
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 in Dextrose
- Generic name (nonproprietary)
- milrinone lactate
- Active ingredients
- Milrinone lactate — .2 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Gland Pharma Limited
- 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 68083-410_4522009c-38db-44c1-8d16-c44f674a9920SPL ID 4522009c-38db-44c1-8d16-c44f674a9920SPL set ID 838da14b-c070-4c09-b088-99e7c64d9964RxCUI 1791840, 1791842UNII 9K8XR81MO8UPC 0368083410018, 0368083411015
- 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
N468083041010followed by a unit qualifier and the quantityPackage 68083-0410-10. 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 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 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 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 | 68083-411 |
| Milrinone Lactate in Dextrose | Milrinone lactate .2 mg/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-1983 |
| Milrinone Lactate in Dextrose | Milrinone lactate .2 mg/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-2045 |