Palonosetron Hydrochloride
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 HCl injection, for intravenous use Initial U.S. Approval: 2003
Approved
Approval ID
5bfb3984-2b47-4e06-9bbb-d055ebc376c8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 13, 2022
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Palonosetron Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0781-3415
Application NumberANDA202521
Product Classification
M
Marketing Category
C73584
G
Generic Name
Palonosetron Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 13, 2022
FDA Product Classification
INGREDIENTS (8)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
PALONOSETRON HYDROCHLORIDEActive
Quantity: 0.25 mg in 5 mL
Code: 23310D4I19
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT