Nystatin
NYSTATIN ORAL SUSPENSION, USP 100,000 Units/mL
Approved
Approval ID
41034d7b-33a1-4d6d-b425-9cfefff8d518
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 30, 2022
Manufacturers
FDA
VistaPharm, Inc.
DUNS: 116743084
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nystatin
PRODUCT DETAILS
NDC Product Code66689-008
Application NumberANDA064142
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 30, 2022
Generic NameNystatin
INGREDIENTS (11)
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
NYSTATINActive
Quantity: 100000 [USP'U] in 1 mL
Code: BDF1O1C72E
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
Nystatin
PRODUCT DETAILS
NDC Product Code66689-037
Application NumberANDA064142
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 30, 2022
Generic NameNystatin
INGREDIENTS (10)
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
NYSTATINActive
Quantity: 100000 [USP'U] in 1 mL
Code: BDF1O1C72E
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT