Prescription drug · ANDA
Posaconazole NDC 63323-685
Posaconazole 18 mg/mL · Injection, Solution · Intravenous · Fresensius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-685-17 | 6332306851763323068517 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-685-17) / 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, Solution
- Route
- Intravenous
- Labeler
- Fresensius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209983
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 63323-685_3ed81dc8-a1e0-4513-be2a-7a16aea62198SPL ID 3ed81dc8-a1e0-4513-be2a-7a16aea62198SPL set ID 86be8cdb-c991-4754-b8f4-1ab79ac40bdaRxCUI 1492043UNII 6TK1G07BHZUPC 0363323685171
- 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
N463323068517followed by a unit qualifier and the quantityPackage 63323-0685-17. 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 injection is indicated for the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older. ( 1.1 ) Posaconazole 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 ) Posaconazole injection: adults and pediatric patients 2 years of age and older 1.1 Treatment …
Excerpt only. Read the full label for complete information.
About NDC 63323-685
- What is NDC 63323-685?
- 63323-685 is the product NDC for Posaconazole, Posaconazole 18 mg/mL injection, solution, listed with the FDA by Fresensius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Posaconazole.
- What is the active ingredient?
- Posaconazole.
- Who is the labeler?
- Fresensius 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 Posaconazole?
- 32 other product NDCs are listed under this name. See all Posaconazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Posaconazole products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| posaconazole | Posaconazole 100 mg/1 | Tablet, CoatedOral | Novadoz Pharmaceuticals LLC | 72205-168 | 72205-0168-60 |
| Posaconazole | Posaconazole 18 mg/mL | SolutionIntravenous | Camber Pharmaceuticals, Inc. | 31722-370 | 31722-0370-31 |
| Posaconazole | Posaconazole 100 mg/1 | Tablet, Delayed releaseOral | Aurobindo Pharma Limited | 59651-596 | 59651-0596-60 |
| posaconazole | Posaconazole 18 mg/mL | Injection, SolutionIntravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-911 | 68462-0911-01 |
| Posaconazole | Posaconazole 100 mg/1 | Tablet, Delayed releaseOral | A2A Integrated Pharmaceuticals | 73141-023 | 73141-0023-02 |
| posaconazole | Posaconazole 18 mg/mL | SolutionIntravenous | Mylan Institutional LLC | 67457-665 | 67457-0665-20 |
| posaconazole | Posaconazole 18 mg/mL | Injection, SolutionIntravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-904 | 68462-0904-01 |
| Posaconazole | Posaconazole 18 mg/mL | InjectionIntravenous | Eugia US LLC | 55150-388 | 55150-0388-01 |
| posaconazole | Posaconazole 18 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-577 | 68083-0577-01 |
| Posaconazole | Posaconazole 100 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-2665 | 71335-2665-01 |