Itraconazole
- Product NDC
- 60687-299
- 11-digit product format
- 606870299
- Labeler code
- 60687
- Product ID
- 60687-299_31555f81-410c-9a69-e063-6394a90ab705
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Itraconazole
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA205080
- Marketing category
- ANDA
- Marketing start
- 2017-05-02
- 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 |
|---|
| 60687-299-25 | Itraconazole | 30 in 1 BOX, UNIT-DOSE | CAPSULE | 30 | | 8 |
| 60687-299-95 | Itraconazole | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-299 | ITRACONAZOLE CAPSULE [AMERICAN HEALTH PACKAGING] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250330_e564067e-e469-4c51-9076-75f89f5c5cdf.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 |
|---|
| 60687-299-25 | 60687029925 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-299-25) / 1 CAPSULE in 1 BLISTER PACK (60687-299-95) | 30 blister pack | 2017-05-02 | 0000-00-00 | No | No | Current |
| 60687-299-95 | 60687029995 | 1 in 1 BLISTER PACK | | | | | | Historical |