Ondansetron
Approved
Approval ID
a360d43c-bed8-4f41-ab36-e2aa77dfbff2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 15, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ondansetron Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5888
Application NumberANDA076781
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ondansetron Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 15, 2011
FDA Product Classification
INGREDIENTS (6)
ONDANSETRON HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: NMH84OZK2B
Classification: ACTIB
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT