Voriconazole
- Product NDC
- 65162-913
- 11-digit product format
- 651620913
- Labeler code
- 65162
- Product ID
- 65162-913_ac791850-702b-4495-9ff5-499c7b054c79
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Voriconazole
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA205034
- Marketing category
- ANDA
- Marketing start
- 2013-11-29
- Substance
- VORICONAZOLE
- Active strength
- 40 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 | 40 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JFU09I87TR |
| Rxcui | 465355 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-913-22 | Voriconazole | 75 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 75 | | 25 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-913 | VORICONAZOLE POWDER, FOR SUSPENSION [AMNEAL PHARMACEUTICALS LLC] | 22 | Current NDC, Legacy NDC, 1 package rows | 20231221_ed6624a9-0b73-4a21-bf13-a8add2081d02.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65162-913-22 | 65162091322 | 75 mL in 1 BOTTLE (65162-913-22) | 75 ml | 2013-11-29 | 0000-00-00 | No | No | Current |