Home NDC 50242-623 Rozlytrek
Product NDC 50242-623
11-digit product format 502420623
Labeler code 50242
Product ID 50242-623_b93e1fc0-614a-4e49-a91d-a409fb2db9f0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ENTRECTINIB
Dosage form PELLET
Route ORAL
Labeler Genentech, Inc.
Application NDA218550
Marketing category NDA
Marketing start 2023-10-20
Substance ENTRECTINIB
Active strength 50 mg/201
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218550-001 ROZLYTREK ENTRECTINIB 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 matching rows.
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.
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 2026-08-18 06:07:40 2026-07 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 a72a2bbeb626…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 a50c72e98297…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 62 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Rozlytrek
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ENTRECTINIB 50 mg/201
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L5ORF0AN1I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2197867 Internal RxNorm lookup 2197873 Internal RxNorm lookup 2197875 Internal RxNorm lookup 2197877 Internal RxNorm lookup 2668595 Internal RxNorm lookup 2668599 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50242-623-01 Rozlytrek 20 in 1 DOSE PACK PELLET 20 18 50242-623-42 Rozlytrek 42 in 1 CARTON PELLET 42 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50242-623 ROZLYTREK (ENTRECTINIB) CAPSULE ROZLYTREK (ENTRECTINIB) PELLET [GENENTECH, INC.] 15 Current NDC, 2 package rows 20241123_c7c71b0c-2549-4495-86b6-c2807fa54908.zip
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 Units Marketing start Sample Exclude flag Status 50242-623-01 50242062301 20 in 1 DOSE PACK Historical 50242-623-42 50242062342 42 DOSE PACK in 1 CARTON (50242-623-42) / 20 PELLET in 1 DOSE PACK (50242-623-01) 42 dose pack 2023-10-20 No No Current