Palonosetron Hydrochloride

Product NDC: 36000-326
11-digit product format: 360000326
Labeler code: 36000
Product ID: 36000-326_4d54b4d2-3572-4693-bfe1-2550abc5f439
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: palonosetron hydrochloride
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Corporation
Application: ANDA206916
Marketing category: ANDA
Marketing start: 2021-11-12
Substance: PALONOSETRON HYDROCHLORIDE
Active strength: .25 mg/5mL
Pharmacologic classes: Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
PALONOSETRON HYDROCHLORIDE	.25 mg/5mL

Field, Values table
Field	Values
Unii	23310D4I19
Rxcui	1728055

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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36000-326-01	Palonosetron Hydrochloride	5 mL in 1 VIAL	INJECTION	5		5
36000-326-02	Palonosetron Hydrochloride	1 in 1 CARTON	INJECTION	1		5

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36000-326-01	ML - Milliliter	36000-326	8a80c252-a1ee-4290-90fb-9c68343b1c39	1	2022-03-09
36000-326-02	ML - Milliliter	36000-326	4e2e03b8-b09e-4bde-bbde-a6113840fa72	1	2022-03-09

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36000-326	PALONOSETRON HYDROCHLORIDE INJECTION [BAXTER HEALTHCARE CORPORATION]	4	Current NDC, Legacy NDC, 2 package rows	20240621_0f3bfe3d-75c8-42eb-84be-570f8e251fdd.zip

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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1728055	palonosetron 0.25 MG in 5 ML Injection	PSN	0f3bfe3d-75c8-42eb-84be-570f8e251fdd	5
1728055	5 ML palonosetron 0.05 MG/ML Injection	SCD	0f3bfe3d-75c8-42eb-84be-570f8e251fdd	5
1728055	palonosetron 0.25 MG per 5 ML Injection	SY	0f3bfe3d-75c8-42eb-84be-570f8e251fdd	5

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36000-326-01	36000032601	5 mL in 1 VIAL	5 ml					Historical
36000-326-02	36000032602	1 VIAL in 1 CARTON (36000-326-02) / 5 mL in 1 VIAL (36000-326-01)	1 vial	2021-11-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Palonosetron Hydrochloride	Baxter Healthcare Corporation	2020-09-15	HUMAN PRESCRIPTION DRUG LABEL	5