Prescription drug · NDA
Cotellic (cobimetinib) NDC 50242-717
Cobimetinib fumarate 20 mg/1 · Tablet, Film coated · Oral · Genentech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50242-717-01 | 50242071701 | 63 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50242-717-01)Marketed from Nov 10, 2015 |
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)
- Cotellic
- Generic name (nonproprietary)
- cobimetinib
- Active ingredients
- Cobimetinib fumarate — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Genentech, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 206192
- Marketing start
- Listing expires
- Other FDA classes
- Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 50242-717_59075332-49ef-4998-98c4-81e61f57d424SPL ID 59075332-49ef-4998-98c4-81e61f57d424SPL set ID c387579e-cee0-4334-bd1e-73f93ac1bde6RxCUI 1722370, 1722376UNII 6EXI96H8SV
- 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
N450242071701followed by a unit qualifier and the quantityPackage 50242-0717-01. 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)
COTELLIC ® is a kinase inhibitor indicated: For the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. ( 1.1 , 14.1 ) As a single agent for the treatment of adult patients with histiocytic neoplasms. ( 1.2 , 14.2 ) 1.1 Unresectable or Metastatic Melanoma COTELLIC ® is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. 1.2 Histiocytic Neoplasms COTELLIC®, as a single agent, is indicated for the treatment of adult patients with histiocytic neoplasms.
Excerpt only. Read the full label for complete information.