Prescription drug · NDA
Zelboraf (Vemurafenib) NDC 50242-090
Vemurafenib 240 mg/1 · Tablet, Film coated · Oral · Genentech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50242-090-02 | 50242009002 | 1 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
N450242009002followed by a unit qualifier and the quantityPackage 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.
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.