Home NDC 70437-240 Nerlynx
Product NDC 70437-240
11-digit product format 704370240
Labeler code 70437
Product ID 70437-240_55a7b5be-747b-8497-e063-6294a90a8923
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name neratinib
Dosage form TABLET
Route ORAL
Labeler Puma Biotechnology, Inc.
Application NDA208051
Marketing category NDA
Marketing start 2017-07-17
Substance NERATINIB MALEATE ANHYDROUS
Active strength 40 mg/1
Pharmacologic classes Kinase Inhibitor [EPC], Kinase 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 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 N208051-001 NERLYNX NERATINIB MALEATE EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17
Orange Book patents# Current patent rows page 1 of 1 · 20 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.
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 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 22 · 878 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 N208051-001 10035788 2028-10-15 U-2043 2018-08-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 10035788 2028-10-15 U-3047 2018-08-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 10035788 2028-10-15 U-3097 2018-08-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 9139558 2028-10-15 U-3097 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 9139558 2028-10-15 U-3047 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 9139558 2028-10-15 U-2043 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 9630946 2028-10-15 U-2043 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 9630946 2028-10-15 U-3047 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 9630946 2028-10-15 U-3097 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 9265784 2029-08-04 U-3047 2021-01-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 9211291 2030-03-24 U-2043 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 9211291 2030-03-24 U-3097 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 8790708 2030-11-05 U-2043 Drug product 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 8790708 2030-11-05 U-3097 Drug product 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 8790708 2030-11-05 U-3047 Drug product 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 8518446 2030-11-20 U-2043 Drug product 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 8518446 2030-11-20 U-3097 Drug product 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 8518446 2030-11-20 U-3047 Drug product 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 7399865 2030-12-29 Drug substance, Drug product 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 8669273 2031-07-18 U-3047 2021-01-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208051-001 10035788 2028-10-15 U-2043 2018-08-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 10035788 2028-10-15 U-3047 2018-08-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 10035788 2028-10-15 U-3097 2018-08-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 9139558 2028-10-15 U-3097 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 9139558 2028-10-15 U-3047 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 9139558 2028-10-15 U-2043 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 9630946 2028-10-15 U-2043 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 9630946 2028-10-15 U-3047 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 9630946 2028-10-15 U-3097 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 9265784 2029-08-04 U-3047 2021-01-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 9211291 2030-03-24 U-2043 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 9211291 2030-03-24 U-3097 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 8790708 2030-11-05 U-2043 Drug product 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 8790708 2030-11-05 U-3097 Drug product 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 8790708 2030-11-05 U-3047 Drug product 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 8518446 2030-11-20 U-2043 Drug product 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 8518446 2030-11-20 U-3097 Drug product 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 8518446 2030-11-20 U-3047 Drug product 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 7399865 2030-12-29 Drug substance, Drug product 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 8669273 2031-07-18 U-3047 2021-01-29 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 65 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 Nerlynx
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NERATINIB MALEATE ANHYDROUS 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9RM7XY23ZS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1940648 Internal RxNorm lookup 1940654 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 70437-240-18 2020-02-07 These highlights do not include all the information needed to use NERLYNX safely and effectively. See full prescribing information for NERLYNX. NERLYNX ® (neratinib) tablets, for oral use Initial U.S. Approval: 2017 70437-240-18 2020-02-07 These highlights do not include all the information needed to use NERLYNX safely and effectively. See full prescribing information for NERLYNX. NERLYNX ® (neratinib) tablets, for oral use Initial U.S. Approval: 2017 70437-240-26 2020-02-07 These highlights do not include all the information needed to use NERLYNX safely and effectively. See full prescribing information for NERLYNX. NERLYNX ® (neratinib) tablets, for oral use Initial U.S. Approval: 2017 70437-240-26 2020-02-07 These highlights do not include all the information needed to use NERLYNX safely and effectively. See full prescribing information for NERLYNX. NERLYNX ® (neratinib) tablets, for oral use Initial U.S. Approval: 2017 70437-240-18 2020-01-31 These highlights do not include all the information needed to use NERLYNX safely and effectively. See full prescribing information for NERLYNX. NERLYNX ® (neratinib) tablets, for oral use Initial U.S. Approval: 2017 70437-240-18 2020-01-31 These highlights do not include all the information needed to use NERLYNX safely and effectively. See full prescribing information for NERLYNX. NERLYNX ® (neratinib) tablets, for oral use Initial U.S. Approval: 2017 70437-240-26 2020-01-31 These highlights do not include all the information needed to use NERLYNX safely and effectively. See full prescribing information for NERLYNX. NERLYNX ® (neratinib) tablets, for oral use Initial U.S. Approval: 2017 70437-240-26 2020-01-31 These highlights do not include all the information needed to use NERLYNX safely and effectively. See full prescribing information for NERLYNX. NERLYNX ® (neratinib) tablets, for oral use Initial U.S. Approval: 2017
DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70437-240 NERLYNX (NERATINIB) TABLET [PUMA BIOTECHNOLOGY, INC.] 17 Current NDC, Legacy NDC, 6 package rows 20240327_d1e41dcf-e82a-47c2-a0ad-6c6eef621834.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 Marketing end Sample Exclude flag Status 70437-240-18 70437024018 1 BOTTLE in 1 BOX (70437-240-18) / 180 TABLET in 1 BOTTLE 1 bottle 2017-07-17 0000-00-00 No No Current 70437-240-26 70437024026 1 BOTTLE in 1 BOX (70437-240-26) / 126 TABLET in 1 BOTTLE 1 bottle 2017-07-17 0000-00-00 No No Current 70437-240-33 70437024033 1 BOTTLE in 1 BOX (70437-240-33) / 133 TABLET in 1 BOTTLE 1 bottle 2017-07-17 0000-00-00 No No Current