Prescription drug · ANDA
Posaconazole NDC 69238-1476
Posaconazole 100 mg/1 · Tablet, Delayed release · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1476-3 | 69238147603 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (69238-1476-3)Marketed from Dec 30, 2022 | |
| 69238-1476-6 | 69238147606 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (69238-1476-6)Marketed from Dec 30, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 100 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216626
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 69238-1476_3f266ed7-06f9-48bf-a520-787aeb4e111cSPL ID 3f266ed7-06f9-48bf-a520-787aeb4e111cSPL set ID 5f795eca-7a03-4c91-9a0e-c1235791b665RxCUI 1482908UNII 6TK1G07BHZUPC 0369238147636
- 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
N469238147603followed by a unit qualifier and the quantityPackage 69238-1476-03. 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 delayed-release tablets are an azole antifungal indicated as follows: Posaconazole delayed-release tablets are 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 delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kg 1.2 Prophylaxis of Invasive Aspergillus and Candida Infections Posacon…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216626
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 100 mg/1 | Tablet, Delayed releaseOral | AvKARE | 42291-919 |