Prescription drug · NDA
Gomekli (Mirdametinib) NDC 82448-260
Mirdametinib 2 mg/1 · Capsule · Oral · SpringWorks Therapeutics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82448-260-42 | 82448026042 | 42 CAPSULE in 1 BOTTLE (82448-260-42)Marketed from Feb 11, 2025 | |
| 82448-260-84 | 82448026084 | 84 CAPSULE in 1 BOTTLE (82448-260-84)Marketed from Feb 11, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Gomekli
- Generic name (nonproprietary)
- mirdametinib
- Active ingredients
- Mirdametinib — 2 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- SpringWorks Therapeutics, Inc.NDC labeler code 82448
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 219389
- Marketing start
- Listing expires
- Other FDA classes
- Mitogen-Activated Protein Kinase Kinase 1 Inhibitors (Mechanism)Mitogen-Activated Protein Kinase Kinase 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 82448-260_5132f76b-c3da-4831-833c-c48cb8eee26aSPL ID 5132f76b-c3da-4831-833c-c48cb8eee26a
- Pharmacologic class
- Kinase Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N482448026042followed by a unit qualifier and the quantityPackage 82448-0260-42. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
The FDA listing for this product does not reference a label (SPL) set.
About NDC 82448-260
- What is NDC 82448-260?
- 82448-260 is the product NDC for Gomekli (mirdametinib), Mirdametinib 2 mg/1 capsule, listed with the FDA by SpringWorks Therapeutics, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gomekli (Mirdametinib).
- What is the active ingredient?
- Mirdametinib.
- Who is the labeler?
- SpringWorks Therapeutics, Inc., NDC labeler code 82448. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gomekli?
- 2 other product NDCs are listed under this name. See all Gomekli NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gomekli products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Gomeklimirdametinib | Mirdametinib 1 mg/1 | CapsuleOral | SpringWorks Therapeutics, Inc. | 82448-130 | 82448-0130-42 |
| Gomeklimirdametinib | Mirdametinib 1 mg/1 | Tablet, For suspensionOral | SpringWorks Therapeutics, Inc. | 82448-134 | 82448-0134-4282448-0134-84 |
Other NDCs under NDA 219389
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Gomeklimirdametinib | Mirdametinib 1 mg/1 | CapsuleOral | SpringWorks Therapeutics, Inc. | 82448-130 |