SPORANOX
- Product NDC
- 50458-295
- 11-digit product format
- 504580295
- Labeler code
- 50458
- Product ID
- 50458-295_efd20928-46f0-cdcf-e053-2a95a90a9e39
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- itraconazole
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Janssen Pharmaceuticals, Inc.
- Application
- NDA020657
- Marketing category
- NDA
- Marketing start
- 1997-02-21
- Marketing end
- 0000-00-00
- Substance
- ITRACONAZOLE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| itraconazole | ACTIVE INGREDIENT | 304NUG5GF4 | SPORANOX (ITRACONAZOLE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.] | 16 | |
| itraconazole | ACTIVE MOIETY | 304NUG5GF4 | SPORANOX (ITRACONAZOLE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.] | 16 | |
| CARAMEL | INACTIVE INGREDIENT | T9D99G2B1R | SPORANOX (ITRACONAZOLE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.] | 16 | |
| CHERRY | INACTIVE INGREDIENT | BUC5I9595W | SPORANOX (ITRACONAZOLE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.] | 16 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | SPORANOX (ITRACONAZOLE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.] | 16 | |
| HYDROXYPROPYL .BETA.-CYCLODEXTRIN | INACTIVE INGREDIENT | 1I96OHX6EK | SPORANOX (ITRACONAZOLE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.] | 16 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | SPORANOX (ITRACONAZOLE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.] | 16 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | SPORANOX (ITRACONAZOLE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.] | 16 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | SPORANOX (ITRACONAZOLE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.] | 16 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | SPORANOX (ITRACONAZOLE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.] | 16 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | SPORANOX (ITRACONAZOLE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.] | 16 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50458-295 | SPORANOX (ITRACONAZOLE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.] | 37 | Legacy NDC | 20241228_ae50721d-ee15-4ee7-9fe7-afd98c56461b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50458-295-15 | 50458029515 | 150 mL in 1 BOTTLE (50458-295-15) | 150 ml | 1997-02-21 | 0000-00-00 | No | No | Current |