Prescription drug · ANDA
Voriconazole NDC 0781-3416
Voriconazole 10 mg/mL · Injection, Powder, Lyophilized, For solution · Intravenous · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-3416-94 | 00781341694 | 1 VIAL, SINGLE-USE in 1 CARTON (0781-3416-94) / 20 mL in 1 VIAL, SINGLE-USEMarketed from May 30, 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)
- Voriconazole
- Generic name (nonproprietary)
- voriconazole
- Active ingredients
- Voriconazole — 10 mg/mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Sandoz Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090862
- 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 0781-3416_aef09a5b-01be-4649-a0d7-fe7c187c8ce1SPL ID aef09a5b-01be-4649-a0d7-fe7c187c8ce1SPL set ID e648a0e4-f324-49dc-a8f6-cf25ff3b2dfeRxCUI 351209UNII 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
N400781341694followed by a unit qualifier and the quantityPackage 00781-3416-94. 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 for injection 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 Voriconazole for injection 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090862
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 10 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Civica, Inc. | 72572-875 |