NITROFURANTOIN
Nitrofurantoin Oral Suspension, USPFOR ORAL USE ONLYRx Only
Approved
Approval ID
c4fc70b5-f6eb-417e-8cc9-5b6e8a6e649f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 5, 2021
Manufacturers
FDA
Nostrum Laboratories, Inc.
DUNS: 791055549
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NITROFURANTOIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70408-239
Application NumberANDA201355
Product Classification
M
Marketing Category
C73584
G
Generic Name
NITROFURANTOIN
Product Specifications
Route of AdministrationORAL
Effective DateJune 5, 2021
FDA Product Classification
INGREDIENTS (11)
NITROFURANTOINActive
Quantity: 25 mg in 5 mL
Code: 927AH8112L
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT