Home NDC 50242-130 ALECENSA
Product NDC 50242-130
11-digit product format 502420130
Labeler code 50242
Product ID 50242-130_3159555e-f227-4168-9e96-96f5b705fad2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ALECTINIB HYDROCHLORIDE
Dosage form CAPSULE
Route ORAL
Labeler Genentech, Inc.
Application NDA208434
Marketing category NDA
Marketing start 2015-12-11
Substance ALECTINIB HYDROCHLORIDE
Active strength 150 mg/1
Pharmacologic classes Kinase Inhibitor [EPC], Kinase 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 43 .
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 N208434-001 ALECENSA ALECTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208434-001 9440922 2030-06-09 Drug product 2016-10-12 N208434-001 9126931 2031-05-29 Drug substance 2015-12-22 N208434-001 9365514 2032-03-04 Drug product 2016-07-11 N208434-001 10350214 2035-04-24 Drug product 2020-03-09 N208434-001 11433076 2035-04-24 Drug product 2022-09-28
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N208434-001 I-947 2027-04-18 N208434-001 ODE-477 2031-04-18
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 · 43 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 2026-09-14 22:38:34 2026-08 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 5 · 196 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N208434-001 9440922 2030-06-09 Drug product 2016-10-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208434-001 9126931 2031-05-29 Drug substance 2015-12-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208434-001 9365514 2032-03-04 Drug product 2016-07-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208434-001 10350214 2035-04-24 Drug product 2020-03-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208434-001 11433076 2035-04-24 Drug product 2022-09-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208434-001 9440922 2030-06-09 Drug product 2016-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208434-001 9126931 2031-05-29 Drug substance 2015-12-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208434-001 9365514 2032-03-04 Drug product 2016-07-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208434-001 10350214 2035-04-24 Drug product 2020-03-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208434-001 11433076 2035-04-24 Drug product 2022-09-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208434-001 9440922 2030-06-09 Drug product 2016-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208434-001 9126931 2031-05-29 Drug substance 2015-12-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208434-001 9365514 2032-03-04 Drug product 2016-07-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208434-001 10350214 2035-04-24 Drug product 2020-03-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208434-001 11433076 2035-04-24 Drug product 2022-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208434-001 9440922 2030-06-09 Drug product 2016-10-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208434-001 9126931 2031-05-29 Drug substance 2015-12-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208434-001 9365514 2032-03-04 Drug product 2016-07-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208434-001 10350214 2035-04-24 Drug product 2020-03-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208434-001 11433076 2035-04-24 Drug product 2022-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208434-001 9440922 2030-06-09 Drug product 2016-10-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208434-001 9126931 2031-05-29 Drug substance 2015-12-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208434-001 9365514 2032-03-04 Drug product 2016-07-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208434-001 10350214 2035-04-24 Drug product 2020-03-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208434-001 11433076 2035-04-24 Drug product 2022-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208434-001 9440922 2030-06-09 Drug product 2016-10-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208434-001 9126931 2031-05-29 Drug substance 2015-12-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208434-001 9365514 2032-03-04 Drug product 2016-07-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208434-001 10350214 2035-04-24 Drug product 2020-03-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208434-001 11433076 2035-04-24 Drug product 2022-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208434-001 9440922 2030-06-09 Drug product 2016-10-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208434-001 9126931 2031-05-29 Drug substance 2015-12-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208434-001 9365514 2032-03-04 Drug product 2016-07-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208434-001 10350214 2035-04-24 Drug product 2020-03-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208434-001 11433076 2035-04-24 Drug product 2022-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208434-001 9440922 2030-06-09 Drug product 2016-10-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208434-001 9126931 2031-05-29 Drug substance 2015-12-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208434-001 9365514 2032-03-04 Drug product 2016-07-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208434-001 10350214 2035-04-24 Drug product 2020-03-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208434-001 11433076 2035-04-24 Drug product 2022-09-28 03ed91905a0d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 97 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base ALECENSA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALECTINIB HYDROCHLORIDE 150 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination P9YY73LO6J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1727479 Internal RxNorm lookup 1727485 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 50242-130-01 2020-07-29 These highlights do not include all the information needed to use ALECENSA safely and effectively. See full prescribing information for ALECENSA. ALECENSA ® (alectinib) capsules, for oral use Initial U.S. Approval: 2015 50242-130-01 2020-07-29 These highlights do not include all the information needed to use ALECENSA safely and effectively. See full prescribing information for ALECENSA. ALECENSA ® (alectinib) capsules, for oral use Initial U.S. Approval: 2015 50242-130-01 2020-07-29 These highlights do not include all the information needed to use ALECENSA safely and effectively. See full prescribing information for ALECENSA. ALECENSA ® (alectinib) capsules, for oral use Initial U.S. Approval: 2015 50242-130-86 2020-07-29 These highlights do not include all the information needed to use ALECENSA safely and effectively. See full prescribing information for ALECENSA. ALECENSA ® (alectinib) capsules, for oral use Initial U.S. Approval: 2015 50242-130-86 2020-07-29 These highlights do not include all the information needed to use ALECENSA safely and effectively. See full prescribing information for ALECENSA. ALECENSA ® (alectinib) capsules, for oral use Initial U.S. Approval: 2015 50242-130-86 2020-07-29 These highlights do not include all the information needed to use ALECENSA safely and effectively. See full prescribing information for ALECENSA. ALECENSA ® (alectinib) capsules, for oral use Initial U.S. Approval: 2015 50242-130-01 2020-07-22 These highlights do not include all the information needed to use ALECENSA safely and effectively. See full prescribing information for ALECENSA. ALECENSA ® (alectinib) capsules, for oral use Initial U.S. Approval: 2015 50242-130-01 2020-07-22 These highlights do not include all the information needed to use ALECENSA safely and effectively. See full prescribing information for ALECENSA. ALECENSA ® (alectinib) capsules, for oral use Initial U.S. Approval: 2015 50242-130-01 2020-07-22 These highlights do not include all the information needed to use ALECENSA safely and effectively. See full prescribing information for ALECENSA. ALECENSA ® (alectinib) capsules, for oral use Initial U.S. Approval: 2015 50242-130-86 2020-07-22 These highlights do not include all the information needed to use ALECENSA safely and effectively. See full prescribing information for ALECENSA. ALECENSA ® (alectinib) capsules, for oral use Initial U.S. Approval: 2015 50242-130-86 2020-07-22 These highlights do not include all the information needed to use ALECENSA safely and effectively. See full prescribing information for ALECENSA. ALECENSA ® (alectinib) capsules, for oral use Initial U.S. Approval: 2015 50242-130-86 2020-07-22 These highlights do not include all the information needed to use ALECENSA safely and effectively. See full prescribing information for ALECENSA. ALECENSA ® (alectinib) capsules, for oral use Initial U.S. Approval: 2015
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50242-130-01 ALECENSA 1 in 1 CARTON CAPSULE 1 27 50242-130-01 ALECENSA 240 in 1 BOTTLE, PLASTIC CAPSULE 240 27 50242-130-86 ALECENSA 1 in 1 CARTON CAPSULE 1 27 50242-130-86 ALECENSA 240 in 1 BOTTLE, PLASTIC CAPSULE 240 27
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50242-130 ALECENSA (ALECTINIB HYDROCHLORIDE) CAPSULE [GENENTECH, INC.] 24 Current NDC, Legacy NDC, 4 package rows 20241127_42c49deb-713b-427a-9670-08af08adcffb.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 Marketing start Marketing end Sample Exclude flag Status 50242-130-01 50242013001 1 BOTTLE, PLASTIC in 1 CARTON (50242-130-01) / 240 CAPSULE in 1 BOTTLE, PLASTIC 2015-12-11 0000-00-00 No No Current 50242-130-86 50242013086 1 BOTTLE, PLASTIC in 1 CARTON (50242-130-86) / 240 CAPSULE in 1 BOTTLE, PLASTIC 2017-10-10 0000-00-00 Yes No Current