Aloxi

Product NDC: 62856-797
11-digit product format: 628560797
Labeler code: 62856
Product ID: 62856-797_afcfa291-df05-4e5a-9976-87b0cc8bd378
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: palonosetron hydrochloride
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Eisai Inc.
Application: NDA021372
Marketing category: NDA
Marketing start: 2014-05-28
Marketing end: 2022-10-31
Substance: PALONOSETRON HYDROCHLORIDE
Active strength: 0 mg/5mL
Pharmacologic classes: Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	62856-797		D	Discontinued by firm		2026-08-17
excluded package	package	62856-797	62856-797-01	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62856-797-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62856-797-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	62856-797-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	62856-797-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	62856-797-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	62856-797-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	62856-797-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	62856-797-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62856-797-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	62856-797-01	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	62856-797-01	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	62856-797-01	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	62856-797-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	62856-797-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	62856-797-01	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021372-001	ALOXI	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25
N021372-002	ALOXI	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29

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 3 · 84 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
2026-08-18 06:07:40	2026-07	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2003-07-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-02-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021372-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021372-002	AP	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021372-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021372-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021372-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021372-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021372-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021372-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021372-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021372-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021372-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021372-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021372-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021372-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021372-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021372-002	AP	1	`ea99ee380514…`

Observed Orange Book patent history#

Patent history page 1 of 37 · 1,470 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	7947724	2024-01-30		Drug product	2011-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	7947725	2024-01-30		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	7960424	2024-01-30		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	8518981	2024-01-30		Drug product	2013-09-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	8598218	2024-01-30		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	8598219	2024-01-30		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	8729094	2024-01-30	U-528	Drug product	2014-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9066980	2024-01-30	U-528	Drug product	2015-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9125905	2024-01-30		Drug product	2015-09-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9173942	2024-01-30		Drug product	2015-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9439854	2024-01-30		Drug product	2016-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9457020	2024-01-30		Drug product	2016-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9457021	2024-01-30		Drug product	2016-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	7947724*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	7947725*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	7960424*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	8518981*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	8598218*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	8598219*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	8729094*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9066980*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9125905*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9173942*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9439854*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9457020*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9457021*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	7947724	2024-01-30		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	7947725	2024-01-30		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	7960424	2024-01-30		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	8518981	2024-01-30		Drug product	2013-09-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	8598218	2024-01-30		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	9173942	2024-01-30		Drug product	2015-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	9439854	2024-01-30		Drug product	2016-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	9457020	2024-01-30		Drug product	2016-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	7947724*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	7947725*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	7960424*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	8518981*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	8598218*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	9173942*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62856-797-01	2020-12-28	C162847	48780-1	9d75b9cf-f42b-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use ALOXI safely and effectively. See full prescribing information for ALOXI ALOXI ® (palonosetron HCl) Injection for Intravenous Use Initial U.S. Approval: 2003
62856-797-01	2020-01-31	C162847	48780-1	9d75b9cf-f42b-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use ALOXI safely and effectively. See full prescribing information for ALOXI ALOXI ® (palonosetron HCl) Injection for Intravenous Use Initial U.S. Approval: 2003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62856-797-01	ML - Milliliter	62856-797	2e85bbe2-494b-4ac7-91b2-e5a8f0735129	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PALONOSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	23310D4I19	ALOXI (PALONOSETRON HYDROCHLORIDE) INJECTION [EISAI INC.]	14
PALONOSETRON	ACTIVE MOIETY	5D06587D6R	ALOXI (PALONOSETRON HYDROCHLORIDE) INJECTION [EISAI INC.]	14
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ALOXI (PALONOSETRON HYDROCHLORIDE) INJECTION [EISAI INC.]	14
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	ALOXI (PALONOSETRON HYDROCHLORIDE) INJECTION [EISAI INC.]	14
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ALOXI (PALONOSETRON HYDROCHLORIDE) INJECTION [EISAI INC.]	14
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ALOXI (PALONOSETRON HYDROCHLORIDE) INJECTION [EISAI INC.]	14
WATER	INACTIVE INGREDIENT	059QF0KO0R	ALOXI (PALONOSETRON HYDROCHLORIDE) INJECTION [EISAI INC.]	14

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
palonosetron hydrochloride	PALONOSETRON HYDROCHLORIDE	Cipla USA Inc.	37e7ef89-fd77-44e0-9271-ae91f8822603	2022-01-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021372 application number: NDA021372

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62856-797-01	62856079701	1 VIAL in 1 CARTON (62856-797-01) > 5 mL in 1 VIAL	1 vial	2014-05-28	2022-10-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Aloxi	Eisai Inc. \| Helsinn Advanced Synthesis SA \| Pierre Fabre Medicament Production	2015-12-26	HUMAN PRESCRIPTION DRUG LABEL	21