Nystatin and Triamcinolone
Nystatin and Triamcinolone Acetonide Cream, USP
Approved
Approval ID
9b245d7c-00c0-472e-b213-13fbe9973ee1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 22, 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 and Triamcinolone Acetonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-185
Application NumberANDA062364
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nystatin and Triamcinolone Acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 5, 2008
FDA Product Classification
INGREDIENTS (16)
NystatinActive
Quantity: 100000 [USP'U] in 1 g
Code: BDF1O1C72E
Classification: ACTIB
Triamcinolone AcetonideActive
Quantity: 1 mg in 1 g
Code: F446C597KA
Classification: ACTIB
ALUMINUM HYDROXIDEInactive
Code: 5QB0T2IUN0
Classification: IACT
CETEARETH-15Inactive
Code: 867H4YOZ8Z
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sorbic acidInactive
Code: X045WJ989B
Classification: IACT
sorbitolInactive
Code: 506T60A25R
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT