Itraconazole
- Product NDC
- 31722-006
- 11-digit product format
- 317220006
- Labeler code
- 31722
- Product ID
- 31722-006_2cd3622f-a50f-ec9c-e063-6294a90a3a30
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Itraconazole
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA212239
- Marketing category
- ANDA
- Marketing start
- 2020-09-01
- 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 |
|---|
| 31722-006-31 | Itraconazole | 150 mL in 1 BOTTLE, GLASS | SOLUTION | 150 | | 6 |
| 31722-006-31 | Itraconazole | 1 in 1 CARTON | SOLUTION | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-006 | ITRACONAZOLE (ITRACONAZOLE) SOLUTION [CAMBER PHARMACEUTICALS, INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250130_5af0b33d-bfa6-420b-86f0-067f95b402b2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 31722-006-31 | 31722000631 | 1 BOTTLE, GLASS in 1 CARTON (31722-006-31) / 150 mL in 1 BOTTLE, GLASS | 2020-09-01 | 0000-00-00 | No | No | Current |