Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Hospira Australia Pty Ltd
Hospira, Inc.
758967652
Zydus Hospira Oncology Private Limited
Hospira, Inc.
676190889
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nipent
Product Details
NDC Product Code
0409-0801Application Number
NDA020122Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
December 20, 2023PentostatinActive
Code: 395575MZO7Class: ACTIBQuantity: 2 mg in 1 mL
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT