Palonosetron
These highlights do not include all the information needed to use PALONOSETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for PALONOSETRON HYDROCHLORIDE INJECTION. PALONOSETRON HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 2003
Approved
Approval ID
689c953c-2120-2546-67a4-22bb34ba3330
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 26, 2023
Manufacturers
FDA
NorthStar Rx LLC
DUNS: 830546433
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Palonosetron
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-834
Application NumberANDA201533
Product Classification
M
Marketing Category
C73584
G
Generic Name
Palonosetron
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 26, 2023
FDA Product Classification
INGREDIENTS (5)
Palonosetron HydrochlorideActive
Quantity: 0.05 mg in 1 mL
Code: 23310D4I19
Classification: ACTIM
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
sodium acetateInactive
Code: 4550K0SC9B
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT