Palonosetron

Product NDC: 68001-482
Requested package NDC: 68001-482-25
11-digit product format: 680010482
Labeler code: 68001
Product ID: 68001-482_ecf9957d-55d8-6f94-e053-2995a90a6cba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Palonosetron Hydrochloride
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: BluePoint Laboratories
Application: ANDA205648
Marketing category: ANDA
Marketing start: 2021-01-25
Marketing end: 2023-07-31
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#

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	68001-482	68001-482-25	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A205648-001	PALONOSETRON HYDROCHLORIDE	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2018-09-19
A205648-002	PALONOSETRON HYDROCHLORIDE	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2018-09-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A205648-001	AP

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	A205648-001	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP		2018-09-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A205648-002	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS			2018-09-19	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A205648-001	AP	1	`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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Palonosetron	PALONOSETRON HYDROCHLORIDE	BLuePoint Laboratories	bb2be46a-56f7-48b6-bb05-3c6b12c8b1ea	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205648 application number: ANDA205648
Palonosetron	PALONOSETRON HYDROCHLORIDE	Apotex Corp.	4af600d1-0ab1-41c5-af2f-9dc24cf3c90e	2025-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205648 application number: ANDA205648
Palonosetron	PALONOSETRON HYDROCHLORIDE	Apotex Corp.	903d7aba-277e-6d28-4fee-fd2d605ab6a9	2025-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205648 application number: ANDA205648
Palonosetron	PALONOSETRON HYDROCHLORIDE	Qilu Pharmaceutical Co., Ltd.	633abdc2-a942-4eb2-a0f8-f9f4e727211e	2021-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205648 application number: ANDA205648

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-482-25	ML - Milliliter	68001-482	90c9f7ed-27fa-4f76-b17e-90cf80c48c3f	1	2021-04-08

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
68001-482-25	68001048225	1 VIAL in 1 CARTON (68001-482-25) > 5 mL in 1 VIAL	1 vial	2021-01-25	2023-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Palonosetron	BluePoint Laboratories \| Qilu Pharmaceutical Co., Ltd. \| Qilu Pharmaceutical (Hainan) Co., Ltd.	2022-11-08	HUMAN PRESCRIPTION DRUG LABEL	3