Prescription drug · ANDA
posaconazole NDC 0054-0449
Posaconazole 40 mg/mL · Suspension · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-0449-49 | 00054044949 | 1 BOTTLE, GLASS in 1 CARTON (0054-0449-49) / 105 mL in 1 BOTTLE, GLASSMarketed from Mar 29, 2023 |
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)
- posaconazole
- Generic name (nonproprietary)
- posaconazole
- Active ingredients
- Posaconazole — 40 mg/mL
- Dosage form
- Suspension
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208773
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 0054-0449_cf1fc2ce-44cf-47fa-abce-50b4050f4a3bSPL ID cf1fc2ce-44cf-47fa-abce-50b4050f4a3bSPL set ID 282ddea7-47d8-44e4-8806-169d7cafa951RxCUI 665019UNII 6TK1G07BHZ
- 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400054044949followed by a unit qualifier and the quantityPackage 00054-0449-49. 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 is an azole antifungal indicated as follows: • Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in adults and pediatric patients 13 years of age and older 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. ( 1.2 ) • Posaconazole oral suspension is indicated for the treatment of oropharyngeal candidiasis (OPC), including OPC refractory (rOPC) to itraconazole and/or fluconazole in adults and pediatric patients aged …
Excerpt only. Read the full label for complete information.