Prescription drug · NDA
Mekinist (Trametinib) NDC 0078-1112
Trametinib dimethyl sulfoxide 2 mg/1 · Tablet, Film coated · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-1112-15 | 00078111215 | 30 TABLET, FILM COATED in 1 BOTTLE (0078-1112-15)Marketed from Dec 22, 2021 | |
| 0078-1112-94 | 00078111294 | 14 TABLET, FILM COATED in 1 BOTTLE (0078-1112-94)Marketed from Dec 22, 2021 · Sample package |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Mekinist
- Generic name (nonproprietary)
- trametinib
- Active ingredients
- Trametinib dimethyl sulfoxide — 2 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204114
- Marketing start
- Listing expires
- Other FDA classes
- Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 0078-1112_235e3bc1-099b-4587-9d72-b02fcc3387d1SPL ID 235e3bc1-099b-4587-9d72-b02fcc3387d1SPL set ID 0002ad27-779d-42ab-83b5-bc65453412a1RxCUI 1425110, 1425116, 1425118, 2632560, 2632564, 1425104UNII BSB9VJ5TUT
- 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
N400078111215followed by a unit qualifier and the quantityPackage 00078-1112-15. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
MEKINIST is a kinase inhibitor indicated as a single agent for the treatment of BRAF-inhibitor treatment-naïve patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. ( 1.1 , 2.1 ) MEKINIST is indicated, in combination with dabrafenib, for: the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. ( 1.1 , 2.1 ) the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. ( 1.2 , 2.1 ) the treatment of patients with metastati…
Excerpt only. Read the full label for complete information.
About NDC 0078-1112
- What is NDC 0078-1112?
- 0078-1112 is the product NDC for Mekinist (trametinib), Trametinib dimethyl sulfoxide 2 mg/1 tablet, film coated, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mekinist (Trametinib).
- What is the active ingredient?
- Trametinib dimethyl sulfoxide.
- Who is the labeler?
- Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Mekinist?
- 2 other product NDCs are listed under this name. See all Mekinist NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Mekinist products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Mekinisttrametinib | Trametinib dimethyl sulfoxide .05 mg/mL | Powder, For solutionOral | Novartis Pharmaceuticals Corporation | 0078-1161 | 00078-1161-47 |
| Mekinisttrametinib | Trametinib dimethyl sulfoxide .5 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-1105 | 00078-1105-15 |
Other NDCs under NDA 204114
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 |
|---|---|---|---|---|
| Mekinisttrametinib | Trametinib dimethyl sulfoxide .5 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-1105 |