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 HYDROCHLORIDE injection, for intravenous useInitial U.S. Approval: 2003
Approved
Approval ID
ba2ece34-a3da-420d-a79c-4e53d11af5f3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2023
Manufacturers
FDA
Virtus Pharmaceuticals, LLC
DUNS: 079659493
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
NDC Product Code69543-371
Application NumberANDA209287
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateOctober 31, 2023
Generic NamePalonosetron hydrochloride
INGREDIENTS (8)
PALONOSETRON HYDROCHLORIDEActive
Quantity: 0.25 mg in 5 mL
Code: 23310D4I19
Classification: ACTIM
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT