AKYNZEO

Product NDC: 69639-105
11-digit product format: 696390105
Labeler code: 69639
Product ID: 69639-105_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: 2020-06-15
Substance: FOSNETUPITANT; PALONOSETRON HYDROCHLORIDE
Active strength: 260; .28 mg/20mL; mg/20mL
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

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 (product): 69639-105

Additional Listing Data#

Finished product: Yes
Brand name base: AKYNZEO
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FOSNETUPITANT	260 mg/20mL
PALONOSETRON HYDROCHLORIDE	.28 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
23310D4I19	Internal UNII lookup
7732P08TIR	Internal UNII lookup
T672P80L2S	Internal UNII lookup
5D06587D6R	Internal UNII lookup

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8e47618e-af46-4d82-94e8-1507c042252d	Available on FDA.report

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
69639-105-01	AKYNZEO	20 mL in 1 VIAL	INJECTION	20		18
69639-105-01	AKYNZEO	1 in 1 CARTON	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
69639-105-01	ML - Milliliter	69639-105	e7d7cbe1-35fb-42e9-8544-dc0fb48cc90c	1	2020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69639-105	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
69639-105-01	69639010501	1 VIAL in 1 CARTON (69639-105-01) / 20 mL in 1 VIAL	1 vial	2020-06-15	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