Xospata
- Product NDC
- 0469-1425
- 11-digit product format
- 004691425
- Labeler code
- 0469
- Product ID
- 0469-1425_b1aef238-5cd9-47cb-a83f-1f5eac49f013
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gilteritinib
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Astellas Pharma US, Inc.
- Application
- NDA211349
- Marketing category
- NDA
- Marketing start
- 2018-11-29
- Substance
- GILTERITINIB FUMARATE
- Active strength
- 40 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Xospata
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GILTERITINIB FUMARATE | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5RZZ0Z1GJT |
| Rxcui | 2105811, 2105817 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0469-1425 | XOSPATA (GILTERITINIB) TABLET [ASTELLAS PHARMA US, INC.] | 10 | Current NDC, Legacy NDC, 4 package rows | 20250125_b5ff59aa-9c0d-49a8-9053-1f179b482383.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 |
|---|
| 0469-1425-21 | 00469142521 | 1 BOTTLE in 1 CARTON (0469-1425-21) / 21 TABLET in 1 BOTTLE | 1 bottle | 2022-04-30 | 0000-00-00 | Yes | No | Current |
| 0469-1425-90 | 00469142590 | 1 BOTTLE in 1 CARTON (0469-1425-90) / 90 TABLET in 1 BOTTLE | 1 bottle | 2018-11-29 | 0000-00-00 | No | No | Current |