Prescription drug · ANDA
voriconazole NDC 63629-8734
Voriconazole 200 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8734-1 | 63629873401 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-8734-1)Marketed from Dec 12, 2011 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200265
- 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 63629-8734_d7d66c66-0efb-4ad0-9245-2ed7790b0e0aSPL ID d7d66c66-0efb-4ad0-9245-2ed7790b0e0aSPL set ID 711e5a1b-8c40-4b18-9f4f-12c8ab351012RxCUI 349434UNII 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
N463629873401followed by a unit qualifier and the quantityPackage 63629-8734-01. 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 tablets are an azole antifungal indicated for the treatment of adults and pediatric patients aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight 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 (aged 12 to 14 years weighing greater than or …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 200265
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 | Bryant Ranch Prepack | 71335-2911 |
| voriconazole | Voriconazole 50 mg/1 | Tablet, Film coatedOral | Sandoz Inc | 0781-5667 |
| voriconazole | Voriconazole 200 mg/1 | Tablet, Film coatedOral | Sandoz Inc | 0781-5668 |
| voriconazole | Voriconazole 200 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1198 |