zelboraf

Generic: vemurafenib

Labeler: genentech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zelboraf
Generic Name vemurafenib
Labeler genentech, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

vemurafenib 240 mg/1

Manufacturer
Genentech, Inc.

Identifiers & Regulatory

Product NDC 50242-090
Product ID 50242-090_77f36fc9-7ae6-425a-9dff-79ab4476c864
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202429
Listing Expiration 2026-12-31
Marketing Start 2011-08-17

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
protein kinase inhibitors [moa] cytochrome p450 1a2 inhibitors [moa] p-glycoprotein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50242090
Hyphenated Format 50242-090

Supplemental Identifiers

RxCUI
1147223 1147228
UNII
207SMY3FQT
NUI
N0000175605 N0000175076 N0000182138 N0000185503

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name zelboraf (source: ndc)
Generic Name vemurafenib (source: ndc)
Application Number NDA202429 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 240 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (50242-090-02) / 112 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

50242-090-02 1 BOTTLE, PLASTIC in 1 CARTON (50242-090-02) / 112 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Ingredients (1)

vemurafenib (240 mg/1)

Linked Drug Pages (1)

ZELBORAF ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "77f36fc9-7ae6-425a-9dff-79ab4476c864", "openfda": {"nui": ["N0000175605", "N0000175076", "N0000182138", "N0000185503"], "unii": ["207SMY3FQT"], "rxcui": ["1147223", "1147228"], "spl_set_id": ["38eea320-7e0c-485a-bc30-98c3c45e2763"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Protein Kinase Inhibitors [MoA]", "Cytochrome P450 1A2 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Genentech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50242-090-02)  / 112 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "50242-090-02", "marketing_start_date": "20150908"}], "brand_name": "ZELBORAF", "product_id": "50242-090_77f36fc9-7ae6-425a-9dff-79ab4476c864", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 1A2 Inhibitors [MoA]", "Kinase Inhibitor [EPC]", "P-Glycoprotein Inhibitors [MoA]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "50242-090", "generic_name": "Vemurafenib", "labeler_name": "Genentech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZELBORAF", "active_ingredients": [{"name": "VEMURAFENIB", "strength": "240 mg/1"}], "application_number": "NDA202429", "marketing_category": "NDA", "marketing_start_date": "20110817", "listing_expiration_date": "20261231"}