Nystatin
NYSTATIN ORAL SUSPENSION, USP
Approved
Approval ID
ceb0fc2d-9039-4961-84b6-ceb2a2649c50
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2011
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 Code42254-067
Application NumberANDA062512
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nystatin
Product Specifications
Route of AdministrationORAL
Effective DateJune 28, 2010
FDA Product Classification
INGREDIENTS (12)
NystatinActive
Quantity: 100000 [USP'U] in 1 mL
Code: BDF1O1C72E
Classification: ACTIB
waterInactive
Code: 059QF0KO0R
Classification: IACT
sucroseInactive
Code: C151H8M554
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
magnesium aluminum silicateInactive
Code: 6M3P64V0NC
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
potassium phosphate, dibasicInactive
Code: CI71S98N1Z
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
D&C yellow no. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C red no. 40Inactive
Code: WZB9127XOA
Classification: IACT