Mekinist (trametinib) NDC 0078-1112

NDC codes

FDA NDC Directory

Product NDC (as listed)0078-1112Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00078-1112Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
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 Corporation
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 204114
Marketing start: Mar 17, 2016
Listing expires: Dec 31, 2027
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

N400078111215 followed by a unit qualifier and the quantity

Package 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 May 7, 2026.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 204114

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 204114
Product	Strength	Form · route	Labeler	Product NDC
Mekinisttrametinib	Trametinib dimethyl sulfoxide .5 mg/1	Tablet, Film coatedOral	Novartis Pharmaceuticals Corporation	0078-1105