Voriconazole
- Product NDC
- 59762-0935
- 11-digit product format
- 597620935
- Labeler code
- 59762
- Product ID
- 59762-0935_ab7497d0-3117-4060-ad3c-8ef321979949
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Voriconazole
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- NDA021630
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2013-12-16
- 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 |
|---|
| 59762-0935-3 | Voriconazole | 1 in 1 CARTON | POWDER, FOR SUSPENSION | 1 | | 61 |
| 59762-0935-3 | Voriconazole | 75 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 75 | | 61 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| VORICONAZOLE | ACTIVE INGREDIENT | JFU09I87TR | VORICONAZOLE TABLET, FILM COATED VORICONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] | 12 | |
| VORICONAZOLE | ACTIVE MOIETY | JFU09I87TR | VORICONAZOLE TABLET, FILM COATED VORICONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] | 12 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | VORICONAZOLE TABLET, FILM COATED VORICONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] | 12 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | VORICONAZOLE TABLET, FILM COATED VORICONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] | 12 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | VORICONAZOLE TABLET, FILM COATED VORICONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] | 12 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | VORICONAZOLE TABLET, FILM COATED VORICONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] | 12 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | VORICONAZOLE TABLET, FILM COATED VORICONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] | 12 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | VORICONAZOLE TABLET, FILM COATED VORICONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] | 12 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | VORICONAZOLE TABLET, FILM COATED VORICONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] | 12 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59762-0935 | VORICONAZOLE POWDER, FOR SUSPENSION VORICONAZOLE TABLET, FILM COATED [GREENSTONE LLC] | 57 | Current NDC, Legacy NDC, 2 package rows | 20250331_b8de04a0-238d-4e0b-b0d9-7f7878b149d4.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59762-0935-3 | 59762093503 | 1 BOTTLE in 1 CARTON (59762-0935-3) / 75 mL in 1 BOTTLE | 1 bottle | 2013-12-16 | 0000-00-00 | No | No | Current |