NYSTATIN
NYSTATIN ORAL SUSPENSION, USP (100,000 units per mL)
Approved
Approval ID
608d6f66-64ac-499d-af7c-a7561bdd934c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2024
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code63629-2492
Application NumberANDA062832
Product Classification
M
Marketing Category
C73584
G
Generic Name
NYSTATIN
Product Specifications
Route of AdministrationORAL
Effective DateMarch 11, 2022
FDA Product Classification
INGREDIENTS (11)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
HEXASODIUM HEXAMETAPHOSPHATEInactive
Code: N40N91DW96
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
NYSTATINActive
Quantity: 100000 [USP'U] in 1 mL
Code: BDF1O1C72E
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Code: 70WT22SF4B
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT