AKYNZEO

Product NDC: 69639-102
Requested package NDC: 69639-102-01
11-digit product format: 696390102
Labeler code: 69639
Product ID: 69639-102_4a6ba486-f8be-41a3-847e-429548867605
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fosnetupitant and Palonosetron
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Helsinn Therapeutics (U.S.), Inc.
Application: NDA210493
Marketing category: NDA
Marketing start: 2018-04-20
Substance: FOSNETUPITANT; PALONOSETRON HYDROCHLORIDE
Active strength: 260; .28 mg/1; mg/1
Pharmacologic classes: Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69639-102	69639-102-01	D	Discontinued by firm		2026-08-03

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
N210493-001	AKYNZEO	FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE	EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL	POWDER / INTRAVENOUS		RLD	2018-04-19
N210493-002	AKYNZEO	FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE	EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-05-27

Orange Book patents#

Current patent rows page 1 of 1 · 24 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210493-001	9186357	2030-11-18	U-2301		2018-05-17
N210493-001	10828297	2030-12-17	U-2301		2020-12-09
N210493-001	10208073	2032-05-23	U-2301		2019-03-08
N210493-001	10717721	2032-05-23		Drug substance	2020-08-19
N210493-001	11312698	2032-05-23		Drug substance, Drug product	2022-05-13
N210493-001	8426450	2032-05-23		Drug substance, Drug product	2018-05-17
N210493-001	8895586	2032-05-23	U-2301		2018-05-17
N210493-001	9403772	2032-05-23	U-2301	Drug substance	2018-05-17
N210493-001	9908907	2032-05-23		Drug substance, Drug product	2018-05-17
N210493-001	10624911	2037-06-02		Drug product	2020-05-26
N210493-001	11529362	2037-06-02		Drug product	2023-01-17
N210493-001	12208109	2037-06-02		Drug product	2025-02-20
N210493-002	9186357	2030-11-18	U-2301		2020-06-24
N210493-002	10828297	2030-12-17	U-2301		2020-12-09
N210493-002	10208073	2032-05-23	U-2301		2020-06-24
N210493-002	10717721	2032-05-23		Drug substance	2020-08-19
N210493-002	11312698	2032-05-23		Drug substance, Drug product	2022-05-13
N210493-002	8426450	2032-05-23		Drug substance, Drug product	2020-06-24
N210493-002	8895586	2032-05-23	U-2301		2020-06-24
N210493-002	9403772	2032-05-23	U-2301	Drug substance	2020-06-24
N210493-002	9908907	2032-05-23		Drug substance, Drug product	2020-06-24
N210493-002	10624911	2037-06-02		Drug product	2020-06-24
N210493-002	11529362	2037-06-02		Drug product	2023-01-17
N210493-002	12208109	2037-06-02		Drug product	2025-02-20

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.

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
2026-08-01 22:54:32	2026-06	N210493-001	AKYNZEO	EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL	POWDER / INTRAVENOUS		RLD	2018-04-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-002	AKYNZEO	EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-05-27	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N210493-001	9186357	2030-11-18	U-2301		2018-05-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-001	10828297	2030-12-17	U-2301		2020-12-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-001	10208073	2032-05-23	U-2301		2019-03-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-001	10717721	2032-05-23		Drug substance	2020-08-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-001	11312698	2032-05-23		Drug substance, Drug product	2022-05-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-001	8426450	2032-05-23		Drug substance, Drug product	2018-05-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-001	8895586	2032-05-23	U-2301		2018-05-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-001	9403772	2032-05-23	U-2301	Drug substance	2018-05-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-001	9908907	2032-05-23		Drug substance, Drug product	2018-05-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-001	10624911	2037-06-02		Drug product	2020-05-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-001	11529362	2037-06-02		Drug product	2023-01-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-001	12208109	2037-06-02		Drug product	2025-02-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-002	9186357	2030-11-18	U-2301		2020-06-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-002	10828297	2030-12-17	U-2301		2020-12-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-002	10208073	2032-05-23	U-2301		2020-06-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-002	10717721	2032-05-23		Drug substance	2020-08-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-002	11312698	2032-05-23		Drug substance, Drug product	2022-05-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-002	8426450	2032-05-23		Drug substance, Drug product	2020-06-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-002	8895586	2032-05-23	U-2301		2020-06-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-002	9403772	2032-05-23	U-2301	Drug substance	2020-06-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-002	9908907	2032-05-23		Drug substance, Drug product	2020-06-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-002	10624911	2037-06-02		Drug product	2020-06-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-002	11529362	2037-06-02		Drug product	2023-01-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-002	12208109	2037-06-02		Drug product	2025-02-20	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AKYNZEO	NETUPITANT AND PALONOSETRON	Helsinn Therapeutics (U.S.), Inc.	8e47618e-af46-4d82-94e8-1507c042252d	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210493 application number: NDA210493 ndc (package): 69639-102-01 ndc (product): 69639-102 ndc11 (package): 69639010201

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
61b26fe6-497b-4f61-a1b1-af738421df7e	Product name	1	20260128
bcdb3cc7-59df-d946-62ec-4c975de6d4f2	Product name	9	20241009
7746e9ce-fd27-4057-b741-9dd7c859eeee	Product name	1	20190219
1daa29fd-a861-43a1-a466-85dcbb6be7ec	Product name	2	20180620
06499cfd-dc01-4a13-ac2b-7239d959d760	Product name	1	20180124

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69639-102-01	AKYNZEO	1 in 1 CARTON	INJECTION	1		18
69639-102-01	AKYNZEO	1 in 1 VIAL	INJECTION	1		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69639-102-01	EA - Each	69639-102	bee161b6-a44a-445d-ba8f-3dbe64e3f3ee	1	2018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69639-102	AKYNZEO (NETUPITANT AND PALONOSETRON) CAPSULE AKYNZEO (FOSNETUPITANT AND PALONOSETRON) INJECTION [HELSINN THERAPEUTICS (U.S.), INC.]	16	Current NDC, Legacy NDC, 2 package rows	20231205_8e47618e-af46-4d82-94e8-1507c042252d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
T672P80L2S	FOSNETUPITANT	1703748-89-3	FOSNETUPITANT
23310D4I19	PALONOSETRON HYDROCHLORIDE	135729-62-3	PALONOSETRON HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2374368	Akynzeo 235 MG / 0.25 MG in 20 ML Injection	PSN	8e47618e-af46-4d82-94e8-1507c042252d	18
2044431	Akynzeo 235 MG / 0.25 MG Injection	PSN	8e47618e-af46-4d82-94e8-1507c042252d	18
1552349	Akynzeo 300 MG / 0.5 MG Oral Capsule	PSN	8e47618e-af46-4d82-94e8-1507c042252d	18
2374366	fosnetupitant 235 MG / palonosetron 0.25 MG in 20 ML Injection	PSN	8e47618e-af46-4d82-94e8-1507c042252d	18
2044429	fosnetupitant 235 MG / palonosetron 0.25 MG Injection	PSN	8e47618e-af46-4d82-94e8-1507c042252d	18
1552343	netupitant 300 MG / palonosetron 0.5 MG Oral Capsule	PSN	8e47618e-af46-4d82-94e8-1507c042252d	18
2374368	20 ML fosnetupitant 11.75 MG/ML / palonosetron 0.0125 MG/ML Injection [Akynzeo]	SBD	8e47618e-af46-4d82-94e8-1507c042252d	18
2044431	fosnetupitant 235 MG / palonosetron 0.25 MG Injection [Akynzeo]	SBD	8e47618e-af46-4d82-94e8-1507c042252d	18
1552349	netupitant 300 MG / palonosetron 0.5 MG Oral Capsule [Akynzeo]	SBD	8e47618e-af46-4d82-94e8-1507c042252d	18
2374366	20 ML fosnetupitant 11.75 MG/ML / palonosetron 0.0125 MG/ML Injection	SCD	8e47618e-af46-4d82-94e8-1507c042252d	18
2044429	fosnetupitant 235 MG / palonosetron 0.25 MG Injection	SCD	8e47618e-af46-4d82-94e8-1507c042252d	18
1552343	netupitant 300 MG / palonosetron 0.5 MG Oral Capsule	SCD	8e47618e-af46-4d82-94e8-1507c042252d	18
2374368	Akynzeo (fosnetupitant 235 MG (equivalent to fosnetupitant chloride HCl 260 MG) / palonosetron 0.25 MG (equivalent to palonosetron HCl 28 MG)) per 20 ML Injection	SY	8e47618e-af46-4d82-94e8-1507c042252d	18
2044431	Akynzeo (fosnetupitant 235 MG / palonosetron 0.25 MG) Injection	SY	8e47618e-af46-4d82-94e8-1507c042252d	18
1552349	Akynzeo (netupitant 300 MG / palonosetron 0.5 MG (palonosetron hydrochloride 0.56 MG)) Oral Capsule	SY	8e47618e-af46-4d82-94e8-1507c042252d	18
1552349	Akynzeo (netupitant 300 MG / palonosetron 0.5) MG Oral Capsule	SY	8e47618e-af46-4d82-94e8-1507c042252d	18
2374366	fosnetupitant 235 MG (equivalent to fosnetupitant chloride HCl 260 MG) / palonosetron 0.25 MG (equivalent to palonosetron HCl 28 MG) per 20 ML Injection	SY	8e47618e-af46-4d82-94e8-1507c042252d	18
2374366	fosnetupitant 235 MG / palonosetron 0.25 MG per 20 ML Injection	SY	8e47618e-af46-4d82-94e8-1507c042252d	18
1552343	netupitant 300 MG / palonosetron 0.5 MG (as palonosetron hydrochloride 0.56 MG) Oral Capsule	SY	8e47618e-af46-4d82-94e8-1507c042252d	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69639-102-01	69639010201	1 VIAL in 1 CARTON (69639-102-01) / 1 INJECTION in 1 VIAL	1 vial	2018-04-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AKYNZEO	Helsinn Therapeutics (U.S.), Inc. \| Helsinn Healthcare SA \| Helsinn Advanced Synthesis SA \| Helsinn Birex Pharmaceuticals LTD \| Baxter Oncology GmbH	2026-06-23	HUMAN PRESCRIPTION DRUG LABEL	19