Prescription drug · ANDA
Voriconazole NDC 48433-147
Voriconazole 200 mg/1 · Tablet, Film coated · Oral · Safecor Health LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 48433-147-03 | 48433014703 | 30 BLISTER PACK in 1 CARTON (48433-147-03) / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-147-01)Marketed from Apr 6, 2026 |
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)
- Voriconazole
- Generic name (nonproprietary)
- voriconazole
- Active ingredients
- Voriconazole — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Safecor Health LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090547
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 48433-147_52e676c9-b249-874a-e063-6294a90a7c7cSPL ID 52e676c9-b249-874a-e063-6294a90a7c7cSPL set ID 23f25c6b-f075-42dc-ae05-63b5bf410929RxCUI 349434, 349435UNII JFU09I87TR
- 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
N448433014703followed by a unit qualifier and the quantityPackage 48433-0147-03. 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)
Voriconazole tablets are an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: Invasive aspergillosis ( 1.1 ) Candidemia in non-neutropenics and other deep tissue Candida infections ( 1.2 ) Esophageal candidiasis ( 1.3 ) Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani , in patients intolerant of, or refractory to, other therapy ( 1.4 ) 1.1 Invasive Aspergillosis Voriconazole is indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive aspergillosis (IA). In clinical trials, the majority of isolates recovered were Aspergillus fumigatus…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090547
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 |
|---|---|---|---|---|
| Voriconazole | Voriconazole 50 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-1626 |
| Voriconazole | Voriconazole 200 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-1640 |
| Voriconazole | Voriconazole 50 mg/1 | Tablet, Film coatedOral | Mylan Institutional Inc. | 51079-164 |
| Voriconazole | Voriconazole 200 mg/1 | Tablet, Film coatedOral | Mylan Institutional Inc. | 51079-165 |
| Voriconazole | Voriconazole 50 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-146 |