Prescription drug · ANDA
Milrinone Lactate NDC 63323-617
Milrinone lactate 1 mg/mL · Injection, Solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-617-10 | 6332306171063323061710 | 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-617-10) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-617-01)Marketed from Aug 1, 2002 | |
| 63323-617-20 | 6332306172063323061720 | 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-617-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-617-02)Marketed from Aug 1, 2002 | |
| 63323-617-50 | 6332306175063323061750 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-617-50) / 50 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 1, 2002 |
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
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075936
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 3 Inhibitors (Mechanism)
- Identifiers
- Product ID 63323-617_7ada1876-c47a-4e3e-bd48-a6a1f486b517SPL ID 7ada1876-c47a-4e3e-bd48-a6a1f486b517SPL set ID ac43ba6b-635d-4129-8eea-96f3f5a4785eRxCUI 1791854, 1791859, 1791861UNII 9K8XR81MO8UPC 0363323617509, 0363323617028, 0363323617011
- 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
N463323061710followed by a unit qualifier and the quantityPackage 63323-0617-10. 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 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.
About NDC 63323-617
- What is NDC 63323-617?
- 63323-617 is the product NDC for Milrinone Lactate, Milrinone lactate 1 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Milrinone Lactate.
- What is the active ingredient?
- Milrinone lactate.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Milrinone Lactate?
- 25 other product NDCs are listed under this name. See all Milrinone Lactate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Milrinone Lactate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Milrinone Lactate | Milrinone lactate 1 mg/mL | Injection, SolutionIntravenous | Shandong New Time Pharmaceutical Co., Ltd. | 42677-338 | 42677-0338-0142677-0338-10 |
| Milrinone Lactate | Milrinone lactate 1 mg/mL | Injection, SolutionIntravenous | Caplin Steriles Limited | 65145-120 | 65145-0120-10 |
| Milrinone Lactate | Milrinone lactate 1 mg/mL | Injection, SolutionIntravenous | Caplin Steriles Limited | 65145-121 | 65145-0121-10 |
| Milrinone Lactate | Milrinone lactate 1 mg/mL | Injection, SolutionIntravenous | Caplin Steriles Limited | 65145-122 | 65145-0122-01 |
| Milrinone Lactate | Milrinone lactate 1 mg/mL | Injection, SolutionIntravenous | Mullan Pharmaceutical Inc. | 83301-0016 | 83301-0016-02 |
| Milrinone Lactate | Milrinone lactate 1 mg/mL | Injection, SolutionIntravenous | Mullan Pharmaceutical Inc. | 83301-0017 | 83301-0017-02 |
| Milrinone Lactate | Milrinone lactate 1 mg/mL | Injection, SolutionIntravenous | Mullan Pharmaceutical Inc. | 83301-0018 | 83301-0018-01 |
| Milrinone Lactate | Milrinone lactate 1 mg/mL | Injection, SolutionIntravenous | Armas Pharmaceuticals Inc. | 72485-501 | 72485-0501-10 |
| Milrinone Lactate | Milrinone lactate 1 mg/mL | Injection, SolutionIntravenous | Armas Pharmaceuticals Inc. | 72485-502 | 72485-0502-10 |
| Milrinone Lactate | Milrinone lactate 1 mg/mL | Injection, SolutionIntravenous | Armas Pharmaceuticals Inc. | 72485-503 | 72485-0503-01 |