Palonosetron Hydrochloride

Product NDC: 0143-9513
11-digit product format: 001439513
Labeler code: 0143
Product ID: 0143-9513_7dc05b1a-344a-410b-a7b3-171727713cf1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Palonosetron Hydrochloride
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: West-Ward Pharmaceuticals Corp
Application: NDA207963
Marketing category: NDA
Marketing start: 2017-09-01
Marketing end: 0000-00-00
Substance: PALONOSETRON HYDROCHLORIDE
Active strength: 0 mg/2mL
Pharmacologic classes: Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	0143-9513		D	Discontinued by firm		2026-08-17
excluded package	package	0143-9513	0143-9513-01	D	Discontinued by firm		2026-08-17

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

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
N207963-001	PALONOSETRON HYDROCHLORIDE	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS			2016-08-22

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS	2016-08-22	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9513-01	ML - Milliliter	0143-9513	cd062fd2-fc5f-4d1c-b738-5bac4ae158bf	1	2018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0143-9513	PALONOSETRON HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICALS CORP]	3	Legacy NDC	20181213_bb20ba9b-aa8c-4b24-8124-aff0cb6c956b.zip

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
0143-9513-01	00143951301	2 mL in 1 VIAL (0143-9513-01)	2 ml	2017-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Palonosetron Hydrochloride	West-Ward Pharmaceuticals Corp	2018-12-12	HUMAN PRESCRIPTION DRUG LABEL	3