ITRACONAZOLE
- Product NDC
- 46708-204
- 11-digit product format
- 467080204
- Labeler code
- 46708
- Product ID
- 46708-204_13a86518-48bc-421b-ad49-c253bd65b488
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- itraconazole
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA206741
- Marketing category
- ANDA
- Marketing start
- 2016-12-16
- 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 |
|---|
| 46708-204-04 | ITRACONAZOLE | 28 in 1 CARTON | CAPSULE | 28 | | 3 |
| 46708-204-10 | ITRACONAZOLE | 100 in 1 CARTON | CAPSULE | 100 | | 3 |
| 46708-204-30 | ITRACONAZOLE | 30 in 1 BOTTLE | CAPSULE | 30 | | 3 |
| 46708-204-71 | ITRACONAZOLE | 500 in 1 BOTTLE | CAPSULE | 500 | | 3 |
| 46708-204-90 | ITRACONAZOLE | 90 in 1 BOTTLE | CAPSULE | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-204 | ITRACONAZOLE CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED] | 3 | Current NDC, Legacy NDC, 5 package rows | 20230121_f9d8b5a7-435f-40e6-8596-5f2376b92c74.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 |
|---|
| 46708-204-04 | 46708020404 | 28 CAPSULE in 1 CARTON (46708-204-04) | 28 capsule | 2016-12-16 | 0000-00-00 | No | No | Current |
| 46708-204-10 | 46708020410 | 100 CAPSULE in 1 CARTON (46708-204-10) | 100 capsule | 2016-12-16 | 0000-00-00 | No | No | Current |
| 46708-204-30 | 46708020430 | 30 CAPSULE in 1 BOTTLE (46708-204-30) | 30 capsule | 2016-12-16 | 0000-00-00 | No | No | Current |
| 46708-204-71 | 46708020471 | 500 CAPSULE in 1 BOTTLE (46708-204-71) | 500 capsule | 2016-12-16 | 0000-00-00 | No | No | Current |
| 46708-204-90 | 46708020490 | 90 CAPSULE in 1 BOTTLE (46708-204-90) | 90 capsule | 2016-12-16 | 0000-00-00 | No | No | Current |