Itraconazole
- Product NDC
- 65162-630
- 11-digit product format
- 651620630
- Labeler code
- 65162
- Product ID
- 65162-630_14950f16-445f-4f48-871f-31bc5328d099
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Itraconazole
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA205080
- Marketing category
- ANDA
- Marketing start
- 2016-09-27
- 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 |
|---|
| 65162-630-03 | Itraconazole | 30 in 1 BOTTLE | CAPSULE | 30 | | 23 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-630 | ITRACONAZOLE CAPSULE [AMNEAL PHARMACEUTICALS LLC] | 23 | Current NDC, Legacy NDC, 1 package rows | 20250202_2ab38a8a-3708-4b97-9f7f-8e554a15348d.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 |
|---|
| 65162-630-03 | 65162063003 | 30 CAPSULE in 1 BOTTLE (65162-630-03) | 30 capsule | 2016-09-27 | 0000-00-00 | No | No | Current |