Itraconazole
- Product NDC
- 65162-087
- 11-digit product format
- 651620087
- Labeler code
- 65162
- Product ID
- 65162-087_fabca3d3-1b0c-48a3-bd56-5e5a11b1fb3b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Itraconazole
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA205573
- Marketing category
- ANDA
- Marketing start
- 2014-04-30
- 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
- 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 | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 304NUG5GF4 |
| Rxcui | 348506 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-087-13 | Itraconazole | 10 mL in 1 CUP, UNIT-DOSE | SOLUTION | 10 | | 19 |
| 65162-087-34 | Itraconazole | 10 in 1 TRAY | SOLUTION | 10 | | 19 |
| 65162-087-74 | Itraconazole | 150 mL in 1 BOTTLE, GLASS | SOLUTION | 150 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-087 | ITRACONAZOLE SOLUTION [AMNEAL PHARMACEUTICALS LLC] | 19 | Current NDC, Legacy NDC, 3 package rows | 20250119_43ded1aa-f825-40fe-aa9a-addd36a07f06.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 |
|---|
| 65162-087-13 | 65162008713 | 10 mL in 1 CUP, UNIT-DOSE | 10 ml | | | | | Historical |
| 65162-087-34 | 65162008734 | 10 CUP, UNIT-DOSE in 1 TRAY (65162-087-34) / 10 mL in 1 CUP, UNIT-DOSE (65162-087-13) | | 2014-04-30 | 0000-00-00 | No | No | Current |
| 65162-087-74 | 65162008774 | 150 mL in 1 BOTTLE, GLASS (65162-087-74) | 150 ml | 2014-04-30 | 0000-00-00 | No | No | Current |