Nystatin
Nystatin Cream USP, 100,000 units per gram FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE
Approved
Approval ID
f4c298d5-b012-7b56-e053-2a95a90a3d55
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 15, 2023
Manufacturers
FDA
RedPharm Drug, Inc
DUNS: 828374897
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 Code67296-1519
Application NumberANDA212557
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nystatin
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 15, 2023
FDA Product Classification
INGREDIENTS (12)
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
NYSTATINActive
Quantity: 100000 U in 1 g
Code: BDF1O1C72E
Classification: ACTIB
ALUMINUM HYDROXIDEInactive
Code: 5QB0T2IUN0
Classification: IACT
CETEARETH-15Inactive
Code: 867H4YOZ8Z
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POLYOXYL 8 STEARATEInactive
Code: 2P9L47VI5E
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT