Prescription drug · NDA
Vfend (Voriconazole) NDC 0049-4190
Voriconazole 10 mg/mL · Injection, Powder, Lyophilized, For solution · Intravenous · Roerig
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0049-4190-01 | 0004941900100049419001 | 1 VIAL, SINGLE-USE in 1 CARTON (0049-4190-01) / 20 mL in 1 VIAL, SINGLE-USEMarketed from Oct 24, 2012 |
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 — 10 mg/mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- RoerigNDC labeler code 0049
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021267
- 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 0049-4190_8900af3a-ee67-45ff-90d3-253ed740abd4SPL ID 8900af3a-ee67-45ff-90d3-253ed740abd4SPL set ID 08d08721-1f4c-478a-8abf-d9c402d50553RxCUI 351209, 352220UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400049419001followed by a unit qualifier and the quantityPackage 00049-4190-01. 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.
About NDC 0049-4190
- What is NDC 0049-4190?
- 0049-4190 is the product NDC for Vfend (voriconazole), Voriconazole 10 mg/mL injection, powder, lyophilized, for solution, listed with the FDA by Roerig. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vfend (Voriconazole).
- What is the active ingredient?
- Voriconazole.
- Who is the labeler?
- Roerig, NDC labeler code 0049. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vfend?
- 3 other product NDCs are listed under this name. See all Vfend NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Vfend products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Vfendvoriconazole | Voriconazole 40 mg/mL | Powder, For suspensionOral | Roerig | 0049-3160 | 00049-3160-44 |
| Vfendvoriconazole | Voriconazole 200 mg/1 | Tablet, Film coatedOral | Roerig | 0049-3180 | 00049-3180-30 |
| Vfendvoriconazole | Voriconazole 10 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Roerig | 0049-3190 | 00049-3190-01 |
Other NDCs under NDA 021267
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.