Nystatin
NYSTATIN CREAM USP
Approved
Approval ID
6cf3daed-075e-4cb8-84fc-00a376fb549f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 4, 2019
Manufacturers
FDA
Central Texas Community Health Centers
DUNS: 079674019
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nystatin
PRODUCT DETAILS
NDC Product Code76413-167
Application NumberANDA062949
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateApril 28, 2017
Generic NameNystatin
INGREDIENTS (15)
NYSTATINActive
Quantity: 100000 [USP'U] in 1 g
Code: BDF1O1C72E
Classification: ACTIB
ALUMINUM HYDROXIDEInactive
Code: 5QB0T2IUN0
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9I
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT