Home NDC 69639-101-01 AKYNZEO
Product NDC 69639-101
Requested package NDC 69639-101-01
11-digit product format 696390101
Labeler code 69639
Product ID 69639-101_4a6ba486-f8be-41a3-847e-429548867605
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Netupitant and Palonosetron
Dosage form CAPSULE
Route ORAL
Labeler Helsinn Therapeutics (U.S.), Inc.
Application NDA205718
Marketing category NDA
Marketing start 2014-10-13
Substance NETUPITANT; PALONOSETRON
Active strength 300; .5 mg/1; mg/1
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], P-Glycoprotein Inhibitors [MoA], Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC], Substance P/Neurokinin-1 Receptor Antagonist [EPC]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205718-001 AKYNZEO NETUPITANT; PALONOSETRON HYDROCHLORIDE 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205718-001 11559523 2030-11-18 U-3522 Drug product 2023-02-22 N205718-001 12042494 2030-11-18 U-3522 Drug product 2024-08-07 N205718-001 8623826 2030-11-18 U-2293 2014-11-06 N205718-001 8951969 2030-11-18 Drug product 2015-03-06 N205718-001 9186357 2030-11-18 U-2293 2015-12-02 N205718-001 9943515 2030-11-18 U-2293 2018-05-16 N205718-001 10828297 2030-12-17 U-2293 2020-12-04 N205718-001 9271975 2031-09-09 U-2293 2016-07-14 N205718-001 10233154 2035-09-25 Drug substance 2019-03-28 N205718-001 10676440 2035-09-25 Drug substance, Drug product 2020-07-08 N205718-001 10961195 2035-09-25 Drug substance, Drug product 2021-04-15 N205718-001 9951016 2035-09-25 Drug substance, Drug product 2018-05-16
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 · 41 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 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N205718-001 AKYNZEO 300MG;EQ 0.5MG BASE CAPSULE / ORAL RLD, RS 2014-10-10 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 12 · 451 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 N205718-001 11559523 2030-11-18 U-3522 Drug product 2023-02-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205718-001 12042494 2030-11-18 U-3522 Drug product 2024-08-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205718-001 8623826 2030-11-18 U-2293 2014-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205718-001 8951969 2030-11-18 Drug product 2015-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205718-001 9186357 2030-11-18 U-2293 2015-12-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205718-001 9943515 2030-11-18 U-2293 2018-05-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205718-001 10828297 2030-12-17 U-2293 2020-12-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205718-001 9271975 2031-09-09 U-2293 2016-07-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205718-001 10233154 2035-09-25 Drug substance 2019-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205718-001 10676440 2035-09-25 Drug substance, Drug product 2020-07-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205718-001 10961195 2035-09-25 Drug substance, Drug product 2021-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205718-001 9951016 2035-09-25 Drug substance, Drug product 2018-05-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205718-001 11559523 2030-11-18 U-3522 Drug product 2023-02-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205718-001 12042494 2030-11-18 U-3522 Drug product 2024-08-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205718-001 8623826 2030-11-18 U-2293 2014-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205718-001 8951969 2030-11-18 Drug product 2015-03-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205718-001 9186357 2030-11-18 U-2293 2015-12-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205718-001 9943515 2030-11-18 U-2293 2018-05-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205718-001 10828297 2030-12-17 U-2293 2020-12-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205718-001 9271975 2031-09-09 U-2293 2016-07-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205718-001 10233154 2035-09-25 Drug substance 2019-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205718-001 10676440 2035-09-25 Drug substance, Drug product 2020-07-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205718-001 10961195 2035-09-25 Drug substance, Drug product 2021-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205718-001 9951016 2035-09-25 Drug substance, Drug product 2018-05-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205718-001 11559523 2030-11-18 U-3522 Drug product 2023-02-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205718-001 12042494 2030-11-18 U-3522 Drug product 2024-08-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205718-001 8623826 2030-11-18 U-2293 2014-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205718-001 8951969 2030-11-18 Drug product 2015-03-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205718-001 9186357 2030-11-18 U-2293 2015-12-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205718-001 9943515 2030-11-18 U-2293 2018-05-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205718-001 10828297 2030-12-17 U-2293 2020-12-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205718-001 9271975 2031-09-09 U-2293 2016-07-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205718-001 10233154 2035-09-25 Drug substance 2019-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205718-001 10676440 2035-09-25 Drug substance, Drug product 2020-07-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205718-001 10961195 2035-09-25 Drug substance, Drug product 2021-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205718-001 9951016 2035-09-25 Drug substance, Drug product 2018-05-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205718-001 11559523 2030-11-18 U-3522 Drug product 2023-02-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205718-001 12042494 2030-11-18 U-3522 Drug product 2024-08-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205718-001 8623826 2030-11-18 U-2293 2014-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205718-001 8951969 2030-11-18 Drug product 2015-03-06 fd3edfee7708…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2019-12-13 00:20 UTC 2019-12 N205718-001 NCE 2019-10-10 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N205718-001 NCE 2019-10-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205718-001 NCE 2019-10-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205718-001 NCE 2019-10-10 ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base AKYNZEO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NETUPITANT 300 mg/1 PALONOSETRON .5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1552343 Internal RxNorm lookup 1552349 Internal RxNorm lookup 2044429 Internal RxNorm lookup 2044431 Internal RxNorm lookup 2374366 Internal RxNorm lookup 2374368 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69639-101 AKYNZEO (NETUPITANT AND PALONOSETRON) CAPSULE AKYNZEO (FOSNETUPITANT AND PALONOSETRON) INJECTION [HELSINN THERAPEUTICS (U.S.), INC.] 16 Current NDC, Legacy NDC, 4 package rows 20231205_8e47618e-af46-4d82-94e8-1507c042252d.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 69639-101-01 69639010101 1 BLISTER PACK in 1 CARTON (69639-101-01) / 1 CAPSULE in 1 BLISTER PACK 1 blister pack 2014-10-13 0000-00-00 No No Current