Prescription drug · ANDA
Voriconazole NDC 50268-803
Voriconazole 200 mg/1 · Tablet, Coated · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-803-12 | 50268080312 | 20 BLISTER PACK in 1 BOX (50268-803-12) / 1 TABLET, COATED in 1 BLISTER PACK (50268-803-11)Marketed from Aug 19, 2022 |
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, Coated
- Route
- Oral
- Labeler
- AvPAK
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206654
- 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 50268-803_2b4d4596-5ea1-cb1d-e063-6394a90ab8ddSPL ID 2b4d4596-5ea1-cb1d-e063-6394a90ab8ddSPL set ID e698e5c7-f4a5-2beb-e053-2995a90a256bRxCUI 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
N450268080312followed by a unit qualifier and the quantityPackage 50268-0803-12. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 206654
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, CoatedOral | Solco Healthcare U.S., LLC | 43547-377 |
| Voriconazole | Voriconazole 200 mg/1 | Tablet, CoatedOral | Solco Healthcare U.S., LLC | 43547-378 |