Palonosetron Hydrochloride

Product NDC: 0143-9513
Requested package NDC: 0143-9513-01
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#

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	0143-9513	0143-9513-01	D	Discontinued by firm		2026-07-31

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
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.

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	N207963-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION / INTRAVENOUS			2016-08-22	`a50c72e98297…`

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