Prescription drug · ANDA
Posaconazole NDC 55150-388
Posaconazole 18 mg/mL · Injection · Intravenous · Eugia US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55150-388-01 | 55150038801 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-388-01) / 16.7 mL in 1 VIAL, SINGLE-DOSEMarketed from Dec 26, 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)
- Posaconazole
- Generic name (nonproprietary)
- posaconazole
- Active ingredients
- Posaconazole — 18 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Eugia US LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214842
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 55150-388_6d1e5905-71b9-480b-82ae-5c92a2374e1dSPL ID 6d1e5905-71b9-480b-82ae-5c92a2374e1dSPL set ID 2e88e379-b712-4dec-97a2-c90ef3638372RxCUI 1492043UNII 6TK1G07BHZUPC 0355150388011
- Pharmacologic class
- Azole Antifungal
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
N455150038801followed by a unit qualifier and the quantityPackage 55150-0388-01. 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)
Posaconazole injection is an azole antifungal indicated as follows: Posaconazole injection is indicated for the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older. (1.1) Posaconazole injection is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: ( 1.2 ) o Posaconazole injection: adults and pediatric patients 2 years of age and …
Excerpt only. Read the full label for complete information.