Nystatin
Nystatin Oral Suspension, USP100,000 units per mL
Approved
Approval ID
8ce02e76-303c-4e06-a47e-0a7bbf46c3f2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 16, 2012
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code42254-322
Application NumberANDA064042
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nystatin
Product Specifications
Route of AdministrationORAL
Effective DateMay 25, 2011
FDA Product Classification
INGREDIENTS (11)
NYSTATINActive
Quantity: 100000 [USP'U] in 1 mL
Code: BDF1O1C72E
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT