Ondansetron
Ondansetron Oral Solution, USP 4 MG/5 ML
Approved
Approval ID
7a3c9566-1847-4867-b528-0e91fb8bab94
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 10, 2011
Manufacturers
FDA
Atlantic Biologicals Corps
DUNS: 047437707
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ondansetron
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code17856-4091
Application NumberANDA091483
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ondansetron
Product Specifications
Route of AdministrationORAL
Effective DateJune 10, 2011
FDA Product Classification
INGREDIENTS (8)
ONDANSETRON HYDROCHLORIDEActive
Quantity: 4 mg in 5 mL
Code: NMH84OZK2B
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SACCHARIN SODIUM DIHYDRATEInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
STRAWBERRYInactive
Code: 4J2TY8Y81V
Classification: IACT