Home NDC 42358-450 Zokinvy
Product NDC 42358-450
11-digit product format 423580450
Labeler code 42358
Product ID 42358-450_027cd79f-a9a2-4038-9296-1f85299b55c5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lonafarnib
Dosage form CAPSULE
Route ORAL
Labeler Sentynl Therapeutics, Inc.
Application NDA213969
Marketing category NDA
Marketing start 2025-07-02
Substance LONAFARNIB
Active strength 50 mg/1
Pharmacologic classes 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]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N213969-001 ZOKINVY LONAFARNIB 50MG CAPSULE / ORAL RLD 2020-11-20 N213969-002 ZOKINVY LONAFARNIB 75MG CAPSULE / ORAL RLD, RS 2020-11-20
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213969-001 7838531 2029-07-26 U-3070 2021-02-24 N213969-002 7838531 2029-07-26 U-3070 2021-02-24
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213969-001 ODE-324 2027-11-20 N213969-002 ODE-324 2027-11-20
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 72 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N213969-001 ZOKINVY 50MG CAPSULE / ORAL RLD 2020-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213969-002 ZOKINVY 75MG CAPSULE / ORAL RLD, RS 2020-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213969-001 ZOKINVY 50MG CAPSULE / ORAL RLD 2020-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213969-002 ZOKINVY 75MG CAPSULE / ORAL RLD, RS 2020-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213969-001 ZOKINVY 50MG CAPSULE / ORAL RLD 2020-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213969-002 ZOKINVY 75MG CAPSULE / ORAL RLD, RS 2020-11-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213969-001 ZOKINVY 50MG CAPSULE / ORAL RLD 2020-11-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213969-002 ZOKINVY 75MG CAPSULE / ORAL RLD, RS 2020-11-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213969-001 ZOKINVY 50MG CAPSULE / ORAL RLD 2020-11-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213969-002 ZOKINVY 75MG CAPSULE / ORAL RLD, RS 2020-11-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213969-001 ZOKINVY 50MG CAPSULE / ORAL RLD 2020-11-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213969-002 ZOKINVY 75MG CAPSULE / ORAL RLD, RS 2020-11-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213969-001 ZOKINVY 50MG CAPSULE / ORAL RLD 2020-11-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213969-002 ZOKINVY 75MG CAPSULE / ORAL RLD, RS 2020-11-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213969-001 ZOKINVY 50MG CAPSULE / ORAL RLD 2020-11-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213969-002 ZOKINVY 75MG CAPSULE / ORAL RLD, RS 2020-11-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213969-001 ZOKINVY 50MG CAPSULE / ORAL RLD 2020-11-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213969-002 ZOKINVY 75MG CAPSULE / ORAL RLD, RS 2020-11-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213969-001 ZOKINVY 50MG CAPSULE / ORAL RLD 2020-11-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213969-002 ZOKINVY 75MG CAPSULE / ORAL RLD, RS 2020-11-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213969-001 ZOKINVY 50MG CAPSULE / ORAL RLD 2020-11-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213969-002 ZOKINVY 75MG CAPSULE / ORAL RLD, RS 2020-11-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213969-001 ZOKINVY 50MG CAPSULE / ORAL RLD 2020-11-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213969-002 ZOKINVY 75MG CAPSULE / ORAL RLD, RS 2020-11-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213969-001 ZOKINVY 50MG CAPSULE / ORAL RLD 2020-11-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213969-002 ZOKINVY 75MG CAPSULE / ORAL RLD, RS 2020-11-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213969-001 ZOKINVY 50MG CAPSULE / ORAL RLD 2020-11-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N213969-002 ZOKINVY 75MG CAPSULE / ORAL RLD, RS 2020-11-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213969-001 ZOKINVY 50MG CAPSULE / ORAL RLD 2020-11-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213969-002 ZOKINVY 75MG CAPSULE / ORAL RLD, RS 2020-11-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213969-001 ZOKINVY 50MG CAPSULE / ORAL RLD 2020-11-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N213969-002 ZOKINVY 75MG CAPSULE / ORAL RLD, RS 2020-11-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213969-001 ZOKINVY 50MG CAPSULE / ORAL RLD 2020-11-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N213969-002 ZOKINVY 75MG CAPSULE / ORAL RLD, RS 2020-11-20 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213969-001 ZOKINVY 50MG CAPSULE / ORAL RLD 2020-11-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N213969-002 ZOKINVY 75MG CAPSULE / ORAL RLD, RS 2020-11-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213969-001 ZOKINVY 50MG CAPSULE / ORAL RLD 2020-11-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N213969-002 ZOKINVY 75MG CAPSULE / ORAL RLD, RS 2020-11-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213969-001 ZOKINVY 50MG CAPSULE / ORAL RLD 2020-11-20 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213969-002 ZOKINVY 75MG CAPSULE / ORAL RLD, RS 2020-11-20 87673890dc5c…
Observed Orange Book patent history# Patent history page 1 of 4 · 132 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N213969-001 7838531 2029-07-26 U-3070 2021-02-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213969-002 7838531 2029-07-26 U-3070 2021-02-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213969-001 8828356 2025-10-17 U-3070 2021-02-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213969-001 7838531 2029-07-26 U-3070 2021-02-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213969-002 8828356 2025-10-17 U-3070 2021-02-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213969-002 7838531 2029-07-26 U-3070 2021-02-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213969-001 8828356 2025-10-17 U-3070 2021-02-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213969-001 7838531 2029-07-26 U-3070 2021-02-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213969-002 8828356 2025-10-17 U-3070 2021-02-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213969-002 7838531 2029-07-26 U-3070 2021-02-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213969-001 7838531 2025-07-26 U-3070 2021-02-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213969-001 8828356 2025-10-17 U-3070 2021-02-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213969-002 7838531 2025-07-26 U-3070 2021-02-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213969-002 8828356 2025-10-17 U-3070 2021-02-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213969-001 7838531 2025-07-26 U-3070 2021-02-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213969-001 8828356 2025-10-17 U-3070 2021-02-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213969-002 7838531 2025-07-26 U-3070 2021-02-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213969-002 8828356 2025-10-17 U-3070 2021-02-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213969-001 7838531 2025-07-26 U-3070 2021-02-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213969-001 8828356 2025-10-17 U-3070 2021-02-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213969-002 7838531 2025-07-26 U-3070 2021-02-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213969-002 8828356 2025-10-17 U-3070 2021-02-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213969-001 7838531 2025-07-26 U-3070 2021-02-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213969-001 8828356 2025-10-17 U-3070 2021-02-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213969-002 7838531 2025-07-26 U-3070 2021-02-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213969-002 8828356 2025-10-17 U-3070 2021-02-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213969-001 7838531 2024-07-26 U-3070 2021-02-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213969-001 8828356 2024-10-17 U-3070 2021-02-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213969-002 7838531 2024-07-26 U-3070 2021-02-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213969-002 8828356 2024-10-17 U-3070 2021-02-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213969-001 7838531 2025-07-26 U-3070 2021-02-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213969-001 8828356 2025-10-17 U-3070 2021-02-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213969-002 7838531 2025-07-26 U-3070 2021-02-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213969-002 8828356 2025-10-17 U-3070 2021-02-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213969-001 7838531 2025-07-26 U-3070 2021-02-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213969-001 8828356 2025-10-17 U-3070 2021-02-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213969-002 7838531 2025-07-26 U-3070 2021-02-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213969-002 8828356 2025-10-17 U-3070 2021-02-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213969-001 7838531 2024-07-26 U-3070 2021-02-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213969-001 8828356 2024-10-17 U-3070 2021-02-24 79d66fd596c7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 134 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Zokinvy
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LONAFARNIB 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination IOW153004F Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2467582 Internal RxNorm lookup 2467588 Internal RxNorm lookup 2467590 Internal RxNorm lookup 2467592 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42358-450-30 Zokinvy 1 in 1 CARTON CAPSULE 1 2 42358-450-30 Zokinvy 30 in 1 BOTTLE, PLASTIC CAPSULE 30 2
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 42358-450-30 42358045030 1 BOTTLE, PLASTIC in 1 CARTON (42358-450-30) / 30 CAPSULE in 1 BOTTLE, PLASTIC 2025-07-02 No No Current