Voriconazole
- Product NDC
- 72572-875
- 11-digit product format
- 725720875
- Labeler code
- 72572
- Product ID
- 72572-875_b0ad9219-4423-4d76-bb2c-f7afe59c1dce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Voriconazole
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Civica, Inc.
- Application
- ANDA090862
- Marketing category
- ANDA
- Marketing start
- 2023-04-01
- 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 | 351209 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72572-875-01 | Voriconazole | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 3 |
| 72572-875-01 | Voriconazole | 20 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 20 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72572-875 | VORICONAZOLE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CIVICA, INC.] | 2 | Current NDC, 2 package rows | 20231111_511fa110-e4cc-4498-80db-03b7cddb1d5a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72572-875-01 | 72572087501 | 1 VIAL, SINGLE-USE in 1 CARTON (72572-875-01) / 20 mL in 1 VIAL, SINGLE-USE | 2023-04-01 | No | No | Current |