Nipent
Approved
Approval ID
674e0e6d-46ed-4868-9196-04019d667716
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2023
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PENTOSTATIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-0801
Application NumberNDA020122
Product Classification
M
Marketing Category
C73594
G
Generic Name
PENTOSTATIN
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 20, 2023
FDA Product Classification
INGREDIENTS (4)
PENTOSTATINActive
Quantity: 2 mg in 1 mL
Code: 395575MZO7
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT