Nystatin and Triamcinolone Acetonide
NYSTATIN AND TRIAMCINOLONE ACETONIDE Cream, USPRx onlyFOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
Approved
Approval ID
09140e74-c5ea-4c45-a5b1-e6f7f9ee1a23
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2024
Manufacturers
FDA
Lupin Pharmaceuticals, Inc.
DUNS: 089153071
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 Code68180-545
Application NumberANDA208205
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nystatin and Triamcinolone Acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 3, 2024
FDA Product Classification
INGREDIENTS (15)
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
TRIAMCINOLONE ACETONIDEActive
Quantity: 1 mg in 1 g
Code: F446C597KA
Classification: ACTIB
NYSTATINActive
Quantity: 100000 [USP'U] in 1 g
Code: BDF1O1C72E
Classification: ACTIB
ALUMINUM HYDROXIDEInactive
Code: 5QB0T2IUN0
Classification: IACT
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUY
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POLYOXYL 8 STEARATEInactive
Code: 2P9L47VI5E
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT