Voriconazole
- Product NDC
- 55150-321
- 11-digit product format
- 551500321
- Labeler code
- 55150
- Product ID
- 55150-321_13107b7f-40e5-4e02-99e7-74469a806b3d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Voriconazole
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA212162
- Marketing category
- ANDA
- Marketing start
- 2023-02-02
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Voriconazole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VORICONAZOLE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JFU09I87TR |
| Rxcui | 351209 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55150-321-01 | Voriconazole | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 20 | | 2 |
| 55150-321-01 | Voriconazole | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-321 | VORICONAZOLE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC] | 2 | Current NDC, 2 package rows | 20240308_171272c7-d76e-4352-81bc-fcb40386d7d0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 55150-321-01 | 55150032101 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-321-01) / 20 mL in 1 VIAL, SINGLE-DOSE | 2023-02-02 | No | No | Current |