Nystatin
Nystatin Oral Suspension, USP
Approved
Approval ID
a0540f97-18a2-4dd5-b3a8-a899c3831f51
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2019
Manufacturers
FDA
Lohxa
DUNS: 079872715
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 Code70166-331
Application NumberANDA062876
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nystatin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2019
FDA Product Classification
INGREDIENTS (13)
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BENZALDEHYDEInactive
Code: TA269SD04T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
NYSTATINActive
Quantity: 100000 [USP'U] in 1 mL
Code: BDF1O1C72E
Classification: ACTIB