NebuPent
NebuPent
Approved
Approval ID
e2ad9d3c-b6c3-4f70-87e0-722a8ff94ccb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 23, 2020
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PENTAMIDINE ISETHIONATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-877
Application NumberNDA019887
Product Classification
M
Marketing Category
C73594
G
Generic Name
PENTAMIDINE ISETHIONATE
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJanuary 23, 2020
FDA Product Classification
INGREDIENTS (1)
PENTAMIDINE ISETHIONATEActive
Quantity: 300 mg in 6 mL
Code: V2P3K60DA2
Classification: ACTIB