NDC codes

FDA NDC Directory
Product NDC (as listed)50242-717Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50242-0717Add 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 NDC11-digit (billing)PackageCopy
50242-717-01502420717015024207170163 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.NDC labeler code 50242
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

N450242071701 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

About NDC 50242-717

What is NDC 50242-717?
50242-717 is the product NDC for Cotellic (cobimetinib), Cobimetinib fumarate 20 mg/1 tablet, film coated, listed with the FDA by Genentech, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cotellic (Cobimetinib).
What is the active ingredient?
Cobimetinib fumarate.
Who is the labeler?
Genentech, Inc., NDC labeler code 50242. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cotellic?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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