IMKELDI
- Product NDC
- 81927-201
- 11-digit product format
- 819270201
- Labeler code
- 81927
- Product ID
- 81927-201_dead98c8-2ac0-4fe6-890a-cc8c92ddcffc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- imatinib oral
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Shorla Oncology Inc.,
- Application
- NDA219097
- Marketing category
- NDA
- Marketing start
- 2024-12-19
- Substance
- IMATINIB MESYLATE
- Active strength
- 80 mg/mL
- Pharmacologic classes
- Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- IMKELDI
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IMATINIB MESYLATE | 80 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8A1O1M485B |
| Rxcui | 2699831, 2699837 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 81927-201-01 | IMKELDI | 140 mL in 1 BOTTLE | SOLUTION | 140 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81927-201 | IMKELDI (IMATINIB ORAL) SOLUTION [SHORLA ONCOLOGY INC.,] | 2 | Current NDC, 1 package rows | 20241220_26658bb7-9ba1-a10e-e063-6394a90a172e.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 |
|---|
| 81927-201-01 | 81927020101 | 140 mL in 1 BOTTLE (81927-201-01) | 140 ml | 2024-12-19 | No | No | Historical |