Nystatin
Nystatin Ointment, USP 100,000 USP Nystatin Units p er Gram For Topical Use Only. Not For Ophthalmic Use. Rx Only
Approved
Approval ID
8f87de59-33f2-32af-ae17-78bf30fb424d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 29, 2023
Manufacturers
FDA
Cosette Pharmaceuticals, Inc.
DUNS: 116918230
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nystatin Ointment
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0713-0686
Application NumberANDA209114
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nystatin Ointment
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 29, 2023
FDA Product Classification
INGREDIENTS (2)
NYSTATINActive
Quantity: 100000 [USP'U] in 1 g
Code: BDF1O1C72E
Classification: ACTIB
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT