DANZITEN
- Product NDC
- 24338-154
- 11-digit product format
- 243380154
- Labeler code
- 24338
- Product ID
- 24338-154_62029a35-74af-47bc-9b7b-93dcaddfd278
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nilotinib
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Azurity Pharmaceuticals, Inc.
- Application
- NDA219293
- Marketing category
- NDA
- Marketing start
- 2024-11-30
- Substance
- NILOTINIB
- Active strength
- 71 mg/1
- Pharmacologic classes
- Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], UGT1A1 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
- DANZITEN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NILOTINIB | 71 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F41401512X |
| Rxcui | 2698564, 2698570, 2698572, 2698574 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 24338-154-01 | DANZITEN | 4 in 1 CARTON | TABLET | 4 | | 3 |
| 24338-154-02 | DANZITEN | 2 in 1 CARTON | TABLET | 2 | | 3 |
| 24338-154-03 | DANZITEN | 14 in 1 BLISTER PACK | TABLET | 14 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 24338-154 | DANZITEN (NILOTINIB) TABLET [AZURITY PHARMACEUTICALS, INC.] | 2 | Current NDC, 3 package rows | 20241130_d288d165-3505-49bb-9b2e-124490d65f49.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 24338-154-01 | 24338015401 | 4 CARTON in 1 CARTON (24338-154-01) / 2 BLISTER PACK in 1 CARTON (24338-154-02) / 14 TABLET in 1 BLISTER PACK (24338-154-03) | 4 carton | 2024-11-30 | No | No | Current |
| 24338-154-02 | 24338015402 | 2 in 1 CARTON | | | | | Historical |
| 24338-154-03 | 24338015403 | 14 in 1 BLISTER PACK | | | | | Historical |