Gomekli
- Product NDC
- 82448-134
- 11-digit product format
- 824480134
- Labeler code
- 82448
- Product ID
- 82448-134_849abb0f-1b19-4b4f-a3fe-113869a59653
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mirdametinib
- Dosage form
- TABLET, FOR SUSPENSION
- Route
- ORAL
- Labeler
- SpringWorks Therapeutics, Inc.
- Application
- NDA219379
- Marketing category
- NDA
- Marketing start
- 2025-02-11
- Substance
- MIRDAMETINIB
- Active strength
- 1 mg/1
- Pharmacologic classes
- Kinase Inhibitor [EPC], Mitogen-Activated Protein Kinase Kinase 1 Inhibitors [MoA], Mitogen-Activated Protein Kinase Kinase 2 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gomekli
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MIRDAMETINIB | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 86K0J5AK6M |
| Rxcui | 2705617, 2705623, 2705626, 2705628, 2705632, 2705635 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82448-134-42 | Gomekli | 42 in 1 BOTTLE | TABLET, FOR SUSPENSION | 42 | | 6 |
| 82448-134-84 | Gomekli | 84 in 1 BOTTLE | TABLET, FOR SUSPENSION | 84 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82448-134 | GOMEKLI (MIRDAMETINIB) CAPSULE GOMEKLI (MIRDAMETINIB) TABLET, FOR SUSPENSION [SPRINGWORKS THERAPEUTICS, INC.] | 4 | Current NDC, 2 package rows | 20250328_4c41bf90-5fa7-4935-a95c-e047ea6bbf8e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82448-134-42 | 82448013442 | 42 TABLET, FOR SUSPENSION in 1 BOTTLE (82448-134-42) | 2025-02-11 | No | No | Historical |
| 82448-134-84 | 82448013484 | 84 TABLET, FOR SUSPENSION in 1 BOTTLE (82448-134-84) | 2025-02-11 | No | No | Historical |