Itraconazole
- Product NDC
- 13668-463
- 11-digit product format
- 136680463
- Labeler code
- 13668
- Product ID
- 13668-463_190020d3-1073-4c51-a948-ed1e371b72ea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Itraconazole
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Torrent Pharmaceuticals Limited
- Application
- ANDA209460
- Marketing category
- ANDA
- Marketing start
- 2018-08-24
- 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
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Itraconazole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ITRACONAZOLE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 304NUG5GF4 |
| Rxcui | 311204 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13668-463-05 | Itraconazole | 500 in 1 BOTTLE | CAPSULE | 500 | | 18 |
| 13668-463-30 | Itraconazole | 30 in 1 BOTTLE | CAPSULE | 30 | | 18 |
| 13668-463-37 | Itraconazole | 28 in 1 CARTON | CAPSULE | 28 | | 18 |
| 13668-463-90 | Itraconazole | 90 in 1 BOTTLE | CAPSULE | 90 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13668-463 | ITRACONAZOLE CAPSULE [TORRENT PHARMACEUTICALS LIMITED] | 18 | Current NDC, Legacy NDC, 4 package rows | 20250114_b1274d78-1096-4ae3-8299-a2e94eaa0ea5.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 |
|---|
| 13668-463-05 | 13668046305 | 500 CAPSULE in 1 BOTTLE (13668-463-05) | 500 capsule | 2018-08-24 | 0000-00-00 | No | No | Current |
| 13668-463-30 | 13668046330 | 30 CAPSULE in 1 BOTTLE (13668-463-30) | 30 capsule | 2018-08-24 | 0000-00-00 | No | No | Current |
| 13668-463-37 | 13668046337 | 28 CAPSULE in 1 CARTON (13668-463-37) | 28 capsule | 2018-08-24 | 0000-00-00 | No | No | Current |
| 13668-463-90 | 13668046390 | 90 CAPSULE in 1 BOTTLE (13668-463-90) | 90 capsule | 2018-08-24 | 0000-00-00 | No | No | Current |
| 13668-463-98 | 13668046398 | 4 CAPSULE in 1 BLISTER PACK (13668-463-98) | 4 capsule | 2018-08-24 | 0000-00-00 | No | No | Current |