Prescription drug · ANDA
Posaconazole NDC 0904-7149
Posaconazole 100 mg/1 · Tablet, Delayed release · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7149-04 | 00904714904 | 30 BLISTER PACK in 1 CARTON (0904-7149-04) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACKMarketed from Feb 3, 2021 | |
| 0904-7149-10 | 00904714910 | 20 BLISTER PACK in 1 CARTON (0904-7149-10) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACKMarketed from Feb 3, 2021 |
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 — 100 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213454
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 0904-7149_09ae8129-0bb6-404c-b65b-3cf2f712b8e3SPL ID 09ae8129-0bb6-404c-b65b-3cf2f712b8e3SPL set ID 8e1e69b8-cf41-47cc-a3ec-1baee55f099aRxCUI 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
N400904714904followed by a unit qualifier and the quantityPackage 00904-7149-04. 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 2 years of age and older who weigh greater than 40 kg 1.2 Prophylaxis of Invasive Aspergillus and Candida Infections Posaconazole delayed-release tablets are indicated fo…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213454
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 | Lupin Pharmaceuticals, Inc. | 70748-258 |