VORICONAZOLE
- Product NDC
- 43386-038
- 11-digit product format
- 433860038
- Labeler code
- 43386
- Product ID
- 43386-038_9b8865b7-cdc3-4505-b9ba-b3ab1bf909d6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- voriconazole
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA206799
- Marketing category
- ANDA
- Marketing start
- 2016-06-01
- 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
- 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 | 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 |
|---|
| 43386-038-60 | VORICONAZOLE | 1 in 1 CARTON | POWDER, FOR SUSPENSION | 1 | | 12 |
| 43386-038-60 | VORICONAZOLE | 75 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 75 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43386-038 | VORICONAZOLE POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS,INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240131_e37525e8-afb4-4583-b2de-af4aab9040d7.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 |
|---|
| 43386-038-60 | 43386003860 | 1 BOTTLE in 1 CARTON (43386-038-60) / 75 mL in 1 BOTTLE | 1 bottle | 2016-06-01 | 0000-00-00 | Yes | No | Current |