zokinvy

Generic: lonafarnib

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

Drug Facts

Product Profile

Brand Name zokinvy
Generic Name lonafarnib
Labeler sentynl therapeutics, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

lonafarnib 75 mg/1

Manufacturer
Sentynl Therapeutics, Inc.

Identifiers & Regulatory

Product NDC 42358-475
Product ID 42358-475_027cd79f-a9a2-4038-9296-1f85299b55c5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213969
Listing Expiration 2027-12-31
Marketing Start 2025-07-02

Pharmacologic Class

Established (EPC)
farnesyltransferase inhibitor [epc]
Mechanism of Action
farnesyltransferase inhibitors [moa] cytochrome p450 2c8 inhibitors [moa] cytochrome p450 3a inhibitors [moa] p-glycoprotein inhibitors [moa] cytochrome p450 2c19 inhibitors [moa] organic anion transporting polypeptide 1b1 inhibitors [moa] organic anion transporting polypeptide 1b3 inhibitors [moa] breast cancer resistance protein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42358475
Hyphenated Format 42358-475

Supplemental Identifiers

RxCUI
2467582 2467588 2467590 2467592
UPC
0342358450305 0342358475308
UNII
IOW153004F
NUI
N0000193938 N0000193939 N0000187062 N0000190114 N0000185503 N0000182140 N0000190107 N0000190108 N0000190113

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 zokinvy (source: ndc)
Generic Name lonafarnib (source: ndc)
Application Number NDA213969 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (42358-475-30) / 30 CAPSULE in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

42358-475-30 1 BOTTLE, PLASTIC in 1 CARTON (42358-475-30) / 30 CAPSULE in 1 BOTTLE, PLASTIC

Ingredients (1)

lonafarnib (75 mg/1)

Linked Drug Pages (1)

Zokinvy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "027cd79f-a9a2-4038-9296-1f85299b55c5", "openfda": {"nui": ["N0000193938", "N0000193939", "N0000187062", "N0000190114", "N0000185503", "N0000182140", "N0000190107", "N0000190108", "N0000190113"], "upc": ["0342358450305", "0342358475308"], "unii": ["IOW153004F"], "rxcui": ["2467582", "2467588", "2467590", "2467592"], "spl_set_id": ["97391d0c-943e-4c5a-8423-68e163aa7f50"], "pharm_class_epc": ["Farnesyltransferase Inhibitor [EPC]"], "pharm_class_moa": ["Farnesyltransferase Inhibitors [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]"], "manufacturer_name": ["Sentynl Therapeutics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (42358-475-30)  / 30 CAPSULE in 1 BOTTLE, PLASTIC", "package_ndc": "42358-475-30", "marketing_start_date": "20250702"}], "brand_name": "Zokinvy", "product_id": "42358-475_027cd79f-a9a2-4038-9296-1f85299b55c5", "dosage_form": "CAPSULE", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "Farnesyltransferase Inhibitor [EPC]", "Farnesyltransferase Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "42358-475", "generic_name": "lonafarnib", "labeler_name": "Sentynl Therapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zokinvy", "active_ingredients": [{"name": "LONAFARNIB", "strength": "75 mg/1"}], "application_number": "NDA213969", "marketing_category": "NDA", "marketing_start_date": "20250702", "listing_expiration_date": "20271231"}