Nystatin
Nystatin Cream USP, 100,000 units per gram
Approved
Approval ID
fb98a6b8-da0c-40f4-9e53-487b541865b5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 8, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-761
Application NumberANDA064022
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nystatin
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 8, 2008
FDA Product Classification
INGREDIENTS (13)
NystatinActive
Quantity: 100000 mg in 1 g
Code: BDF1O1C72E
Classification: ACTIB
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
glyceryl monostearateInactive
Code: 230OU9XXE4
Classification: IACT
CETEARETH-12Inactive
Code: 7V4MR24V5P
Classification: IACT
ALGELDRATEInactive
Code: 03J11K103C
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT