NDC codes

FDA NDC Directory
Product NDC (as listed)50242-090Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50242-0090Add 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
50242-090-02502420090021 BOTTLE, PLASTIC in 1 CARTON (50242-090-02) / 112 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Sep 8, 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)
Zelboraf
Generic name (nonproprietary)
vemurafenib
Active ingredients
Vemurafenib — 240 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 202429
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 1A2 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)Protein Kinase Inhibitors (Mechanism)
Identifiers
Product ID 50242-090_fa75c9ca-ecdf-4906-9cd3-0552e59b91caSPL ID fa75c9ca-ecdf-4906-9cd3-0552e59b91caSPL set ID 38eea320-7e0c-485a-bc30-98c3c45e2763RxCUI 1147223, 1147228UNII 207SMY3FQT
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

N450242009002 followed by a unit qualifier and the quantity

Package 50242-0090-02. 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)

ZELBORAF ® is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. ( 1.1 , 2.1 ) ZELBORAF ® is indicated for the treatment of patients with Erdheim- Chester Disease with BRAF V600 mutation. ( 1.2 , 2.1 ) Limitation of Use: ZELBORAF is not indicated for treatment of patients with wild-type BRAF melanoma ( 2.1 , 5.2 ) 1.1 Unresectable or Metastatic Melanoma ZELBORAF ® is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. Limitation of Use: ZELBORAF is not indicated for treatment of patients with …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50242-090

What is NDC 50242-090?
50242-090 is the product NDC for Zelboraf (vemurafenib), Vemurafenib 240 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?
Zelboraf (Vemurafenib).
What is the active ingredient?
Vemurafenib.
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 Zelboraf?
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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