Pentam 300
Pentam® 300 (pentamidine isethionate for injection)
Approved
Approval ID
cc2b635e-4840-4dc3-a177-5484371680e8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 13, 2022
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 Code63323-113
Application NumberNDA019264
Product Classification
M
Marketing Category
C73594
G
Generic Name
PENTAMIDINE ISETHIONATE
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateSeptember 13, 2022
FDA Product Classification
INGREDIENTS (1)
PENTAMIDINE ISETHIONATEActive
Quantity: 300 mg in 3 mL
Code: V2P3K60DA2
Classification: ACTIB