pentamidine isethionate
For Injection Only
Approved
Approval ID
5c14fbf2-e21f-44b3-b35c-06919d40d7e0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2023
Manufacturers
FDA
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
DUNS: 780779901
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 Code23155-748
Application NumberANDA213806
Product Classification
M
Marketing Category
C73584
G
Generic Name
pentamidine isethionate
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateApril 1, 2021
FDA Product Classification
INGREDIENTS (1)
PENTAMIDINE ISETHIONATEActive
Quantity: 300 mg in 300 mg
Code: V2P3K60DA2
Classification: ACTIB