Prescription drug · NDA
Voriconazole NDC 70594-067
Voriconazole 10 mg/mL · Injection, Powder, Lyophilized, For solution · Intravenous · Xellia Pharmaceuticals USA LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70594-067-01 | 7059400670170594006701 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70594-067-01) / 20 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 24, 2023 |
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 — 10 mg/mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Xellia Pharmaceuticals USA LLCNDC labeler code 70594
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208562
- 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 70594-067_794911b6-dd66-445a-b73d-5037552e0b94SPL ID 794911b6-dd66-445a-b73d-5037552e0b94SPL set ID 9ec6eda2-2f15-423b-9ec6-819379a426e1RxCUI 351209UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N470594006701followed by a unit qualifier and the quantityPackage 70594-0067-01. 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 for injection is an azole antifungal indicated for use in 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 ) Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani , in patients intolerant of, or refractory to, other therapy ( 1.3 ) 1.1 Invasive Aspergillosis Voriconazole for injection is indicated in adults and pediatric patients (aged 12 to 14 years weighing greater than or equal to 50 kg and tho…
Excerpt only. Read the full label for complete information.
About NDC 70594-067
- What is NDC 70594-067?
- 70594-067 is the product NDC for Voriconazole, Voriconazole 10 mg/mL injection, powder, lyophilized, for solution, listed with the FDA by Xellia Pharmaceuticals USA LLC. 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?
- Xellia Pharmaceuticals USA LLC, NDC labeler code 70594. 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 |