NYSTATIN
Approved
Approval ID
bdb80797-20c8-4fbc-8ef8-b85d6aebdce5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 10, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nystatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0242
Application NumberANDA064022
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nystatin
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 10, 2011
FDA Product Classification
INGREDIENTS (12)
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ALGELDRATEInactive
Code: 03J11K103C
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
NYSTATINActive
Quantity: 100000 [USP'U] in 1 g
Code: BDF1O1C72E
Classification: ACTIB
CETEARETH-15Inactive
Code: 867H4YOZ8Z
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT