Prescription drug · ANDA
voriconazole NDC 65841-831
Voriconazole 200 mg/1 · Tablet, Film coated · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65841-831-01 | 65841083101 | 100 TABLET, FILM COATED in 1 BOTTLE (65841-831-01)Marketed from May 25, 2016 | |
| 65841-831-05 | 65841083105 | 500 TABLET, FILM COATED in 1 BOTTLE (65841-831-05)Marketed from May 25, 2016 | |
| 65841-831-06 | 65841083106 | 30 TABLET, FILM COATED in 1 BOTTLE (65841-831-06)Marketed from May 25, 2016 | |
| 65841-831-10 | 65841083110 | 1000 TABLET, FILM COATED in 1 BOTTLE (65841-831-10)Marketed from May 25, 2016 | |
| 65841-831-16 | 65841083116 | 90 TABLET, FILM COATED in 1 BOTTLE (65841-831-16)Marketed from May 25, 2016 | |
| 65841-831-77 | 65841083177 | 10 BLISTER PACK in 1 CARTON (65841-831-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-831-30)Marketed from May 25, 2016 |
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
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206747
- 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 65841-831_7666344f-3ba8-4a08-a828-65b846868dc0SPL ID 7666344f-3ba8-4a08-a828-65b846868dc0SPL set ID bda70104-d84b-4d3f-9ca0-5f4f1ca816adRxCUI 349434, 349435UNII JFU09I87TRUPC 0365841831016, 0365841830019
- 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
N465841083101followed by a unit qualifier and the quantityPackage 65841-0831-01. 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)
Voriconazole is an azole antifungal indicated for the treatment of adults and pediatric patients aged 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 tablets are 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 fumi…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206747
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 200 mg/1 | Tablet, Film coatedOral | Viona Pharmaceuticals Inc | 72578-063 |
| voriconazole | Voriconazole 50 mg/1 | Tablet, Film coatedOral | Viona Pharmaceuticals Inc | 72578-062 |
| voriconazole | Voriconazole 50 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-830 |
| voriconazole | Voriconazole 50 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6596 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.