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
633abdc2-a942-4eb2-a0f8-f9f4e727211e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 2021
Manufacturers
FDA
Qilu Pharmaceutical Co., Ltd.
DUNS: 653878256
Products 2
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 Code67184-0514
Application NumberANDA205648
Product Classification
M
Marketing Category
C73584
G
Generic Name
Palonosetron Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 11, 2020
FDA Product Classification
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PALONOSETRON HYDROCHLORIDEActive
Quantity: 0.25 mg in 5 mL
Code: 23310D4I19
Classification: ACTIM
CITRIC ACID MONOHYDRATEInactive
Quantity: 7.8 mg in 5 mL
Code: 2968PHW8QP
Classification: IACT
SODIUM CITRATEInactive
Quantity: 18.5 mg in 5 mL
Code: 1Q73Q2JULR
Classification: IACT
MANNITOLInactive
Quantity: 207.5 mg in 5 mL
Code: 3OWL53L36A
Classification: IACT
Palonosetron Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67184-0515
Application NumberANDA205648
Product Classification
M
Marketing Category
C73584
G
Generic Name
Palonosetron Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 11, 2020
FDA Product Classification
INGREDIENTS (5)
CITRIC ACID MONOHYDRATEInactive
Quantity: 2.34 mg in 1.5 mL
Code: 2968PHW8QP
Classification: IACT
SODIUM CITRATEInactive
Quantity: 5.55 mg in 1.5 mL
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PALONOSETRON HYDROCHLORIDEActive
Quantity: 0.075 mg in 1.5 mL
Code: 23310D4I19
Classification: ACTIM
MANNITOLInactive
Quantity: 62.25 mg in 1.5 mL
Code: 3OWL53L36A
Classification: IACT