Prescription drug · ANDA
posaconazole NDC 68083-577
Posaconazole 18 mg/mL · Injection, Solution · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-577-01 | 6808305770168083057701 | 1 VIAL in 1 CARTON (68083-577-01) / 16.7 mL in 1 VIALMarketed 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
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217553
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 68083-577_14b6b64b-748b-462f-b654-2554a6a51f9eSPL ID 14b6b64b-748b-462f-b654-2554a6a51f9eSPL set ID 52d9d29e-4a37-4926-aa57-8477f5447b34RxCUI 1492043UNII 6TK1G07BHZUPC 0368083577018
- 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
N468083057701followed by a unit qualifier and the quantityPackage 68083-0577-01. 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 is an azole antifungal indicated as follows: • Posaconazole injection is indicated for the treatment of invasive aspergillosis in adults and pediatric patients 2 years of age and older who weigh 10 kg or greater. ( 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 patie…
Excerpt only. Read the full label for complete information.
About NDC 68083-577
- What is NDC 68083-577?
- 68083-577 is the product NDC for posaconazole, Posaconazole 18 mg/mL injection, solution, listed with the FDA by Gland Pharma Limited. 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?
- Gland Pharma Limited, NDC labeler code 68083. 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 | Fresensius Kabi USA, LLC | 63323-685 | 63323-0685-17 |
| Posaconazole | Posaconazole 100 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-2665 | 71335-2665-01 |
Other NDCs under ANDA 217553
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 |
|---|---|---|---|---|
| posaconazole | Posaconazole 18 mg/mL | Injection, SolutionIntravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-904 |
| posaconazole | Posaconazole 18 mg/mL | Injection, SolutionIntravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-911 |