Prescription drug · ANDA
voriconazole NDC 68462-573
Voriconazole 200 mg/1 · Tablet, Film coated · Oral · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-573-13 | 68462057313 | 3 BLISTER PACK in 1 CARTON (68462-573-13) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Sep 4, 2015 | |
| 68462-573-30 | 68462057330 | 30 TABLET, FILM COATED in 1 BOTTLE (68462-573-30)Marketed from Sep 4, 2015 | |
| 68462-573-90 | 68462057390 | 90 TABLET, FILM COATED in 1 BOTTLE (68462-573-90)Marketed from Sep 4, 2015 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203503
- Marketing start
- Marketing end
- Other FDA classes
- Azoles (Chemical structure)Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 68462-573_1c47b796-6b3e-4321-86f6-f51fbf9a39fbSPL ID 1c47b796-6b3e-4321-86f6-f51fbf9a39fbSPL set ID 4cbac6ad-0faa-4181-a830-27a9f1536b7aRxCUI 349434, 349435UNII JFU09I87TRUPC 0368462573303
- 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
N468462057313followed by a unit qualifier and the quantityPackage 68462-0573-13. 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 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 Aspe…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203503
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 | Glenmark Pharmaceuticals Inc., USA | 68462-572 |
| Voriconazole | Voriconazole 200 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-273 |