Voriconazole
- Product NDC
- 0121-1091
- 11-digit product format
- 001211091
- Labeler code
- 0121
- Product ID
- 0121-1091_942086e6-8d53-4ab9-b49c-c0234164ae91
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Voriconazole Injection
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- ANDA220043
- Marketing category
- ANDA
- Marketing start
- 2026-05-14
- Substance
- VORICONAZOLE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Voriconazole
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VORICONAZOLE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JFU09I87TR |
| Rxcui | 2727399 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0121-1091-55 | Voriconazole | 1 in 1 CARTON | INJECTION | 1 | | 2 |
| 0121-1091-55 | Voriconazole | 20 mL in 1 VIAL, SINGLE-USE | INJECTION | 20 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0121-1091-55 | 00121109155 | 1 VIAL, SINGLE-USE in 1 CARTON (0121-1091-55) / 20 mL in 1 VIAL, SINGLE-USE | 2026-05-14 | No | No | Historical |