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 | 5026808031250268080312 | 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
- AvPAKNDC labeler code 50268
- 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Voriconazole tablets are 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 equal to 50…
Excerpt only. Read the full label for complete information.
About NDC 50268-803
- What is NDC 50268-803?
- 50268-803 is the product NDC for Voriconazole, Voriconazole 200 mg/1 tablet, coated, listed with the FDA by AvPAK. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Voriconazole.
- What is the active ingredient?
- Voriconazole.
- Who is the labeler?
- AvPAK, NDC labeler code 50268. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Voriconazole?
- 52 other product NDCs are listed under this name. See all Voriconazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Voriconazole products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Voriconazole | Voriconazole 50 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-968 | 60687-0968-21 |
| Voriconazole | Voriconazole 200 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-979 | 60687-0979-21 |
| Voriconazolevoriconazole injection | Voriconazole 10 mg/mL | InjectionIntravenous | PAI Holdings, LLC dba PAI Pharma | 0121-1091 | 00121-1091-55 |
| Voriconazole | Voriconazole 50 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-146 | 48433-0146-03 |
| Voriconazole | Voriconazole 200 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-147 | 48433-0147-03 |
| Voriconazole | Voriconazole 10 mg/mL | Injection, SolutionIntravenous | Hainan Poly Pharm. Co., Ltd. | 14335-730 | 14335-0730-10 |
| Voriconazole | Voriconazole 40 mg/mL | Powder, For suspensionOral | Camber Pharmaceuticals, Inc. | 31722-266 | 31722-0266-31 |
| voriconazole | Voriconazole 200 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1198 | 72162-1198-03 |
| voriconazole | Voriconazole 40 mg/mL | Powder, For suspensionOral | Zhejiang Poly Pharm Co., Ltd. | 72673-111 | 72673-0111-30 |
| Voriconazole | Voriconazole 10 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Camber Pharmaceuticals, Inc. | 31722-224 | 31722-0224-31 |
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 |