SPORANOX
- Product NDC
- 50458-290
- 11-digit product format
- 504580290
- Labeler code
- 50458
- Product ID
- 50458-290_b5d1c275-8665-4f63-8232-e34a02c998c7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ITRACONAZOLE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Janssen Pharmaceuticals, Inc.
- Application
- NDA020083
- Marketing category
- NDA
- Marketing start
- 1992-09-11
- Marketing end
- 2026-11-30
- Substance
- ITRACONAZOLE
- Active strength
- 100 mg/1
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SPORANOX
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ITRACONAZOLE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 304NUG5GF4 |
| Rxcui | 311204, 833164 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ITRACONAZOLE | ACTIVE INGREDIENT | 304NUG5GF4 | SPORANOX (ITRACONAZOLE) CAPSULE [JANSSEN PHARMACEUTICALS, INC.] | 10 | |
| ITRACONAZOLE | ACTIVE MOIETY | 304NUG5GF4 | SPORANOX (ITRACONAZOLE) CAPSULE [JANSSEN PHARMACEUTICALS, INC.] | 10 | |
| D&C Red No. 22 | INACTIVE INGREDIENT | 1678RKX8RT | SPORANOX (ITRACONAZOLE) CAPSULE [JANSSEN PHARMACEUTICALS, INC.] | 10 | |
| D&C Red No. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | SPORANOX (ITRACONAZOLE) CAPSULE [JANSSEN PHARMACEUTICALS, INC.] | 10 | |
| FD&C Blue No. 1 | INACTIVE INGREDIENT | H3R47K3TBD | SPORANOX (ITRACONAZOLE) CAPSULE [JANSSEN PHARMACEUTICALS, INC.] | 10 | |
| FD&C Blue No. 2 | INACTIVE INGREDIENT | L06K8R7DQK | SPORANOX (ITRACONAZOLE) CAPSULE [JANSSEN PHARMACEUTICALS, INC.] | 10 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | SPORANOX (ITRACONAZOLE) CAPSULE [JANSSEN PHARMACEUTICALS, INC.] | 10 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | SPORANOX (ITRACONAZOLE) CAPSULE [JANSSEN PHARMACEUTICALS, INC.] | 10 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | SPORANOX (ITRACONAZOLE) CAPSULE [JANSSEN PHARMACEUTICALS, INC.] | 10 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SPORANOX (ITRACONAZOLE) CAPSULE [JANSSEN PHARMACEUTICALS, INC.] | 10 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | SPORANOX (ITRACONAZOLE) CAPSULE [JANSSEN PHARMACEUTICALS, INC.] | 10 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SPORANOX (ITRACONAZOLE) CAPSULE [JANSSEN PHARMACEUTICALS, INC.] | 10 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50458-290 | SPORANOX (ITRACONAZOLE) CAPSULE [JANSSEN PHARMACEUTICALS, INC.] | 27 | Current NDC, Legacy NDC, 5 package rows | 20250101_a4d555fa-787c-40fb-bb7d-b0d4f7318fd0.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 |
|---|
| 50458-290-01 | 50458029001 | 3 BLISTER PACK in 1 CARTON (50458-290-01) / 10 CAPSULE in 1 BLISTER PACK | 3 blister pack | 1992-09-11 | 2026-11-30 | No | No | Current |
| 50458-290-04 | 50458029004 | 30 CAPSULE in 1 BOTTLE (50458-290-04) | 30 capsule | 1992-09-11 | 2026-11-30 | No | No | Current |
| 50458-290-28 | 50458029028 | 7 POUCH in 1 DOSE PACK (50458-290-28) > 1 BLISTER PACK in 1 POUCH > 4 CAPSULE in 1 BLISTER PACK | 7 pouch | 1992-09-11 | 0000-00-00 | No | No | Current |