Prescription drug · ANDA
Posaconazole NDC 70377-038
Posaconazole 100 mg/1 · Tablet, Delayed release · Oral · Biocon Phama Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70377-038-11 | 70377003811 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (70377-038-11)Marketed from Mar 8, 2022 |
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 — 100 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Biocon Phama Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214476
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 70377-038_b7a2fd29-83b5-6ae6-775c-98f91a6c0ea4SPL ID b7a2fd29-83b5-6ae6-775c-98f91a6c0ea4SPL set ID e0e8023a-3c82-e455-a57b-ccc0206ad156RxCUI 1482908UNII 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
N470377003811followed by a unit qualifier and the quantityPackage 70377-0038-11. 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 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 13 years of age and older. 1.2 Prophylaxis of Invasive Aspergillus and Candida Infections Posaconazole delayed-release tablets are indicated for the prophylaxis of invasive…
Excerpt only. Read the full label for complete information.