Prescription drug · NDA
Vfend (voriconazole) NDC 0049-3160
Voriconazole 40 mg/mL · Powder, For suspension · Oral · Roerig
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0049-3160-44 | 00049316044 | 1 BOTTLE in 1 CARTON (0049-3160-44) / 75 mL in 1 BOTTLEMarketed from Mar 28, 2003 |
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)
- Vfend
- Generic name (nonproprietary)
- voriconazole
- Active ingredients
- Voriconazole — 40 mg/mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Roerig
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021630
- 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 0049-3160_cf9f1b2e-eeb4-48bb-9f1a-c2b8d94dfbeaSPL ID cf9f1b2e-eeb4-48bb-9f1a-c2b8d94dfbeaSPL set ID ce3ef5cf-3087-4d92-9d94-9eb8287228dbRxCUI 349434, 349435, 351209, 352218, 352219, 352220, 465355, 546624UNII 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
N400049316044followed by a unit qualifier and the quantityPackage 00049-3160-44. 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)
VFEND is 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 VFEND 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 . There was a …
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021630
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 40 mg/mL | Powder, For suspensionOral | Mylan Pharmaceuticals Inc. | 59762-0935 |