FOSAPREPITANT
These highlights do not include all the information needed to use FOSAPREPITANT FOR INJECTION safely and effectively. See full prescribing information for FOSAPREPITANT FOR INJECTION. Fosaprepitant for injection, for intravenous use Initial U.S. Approval: 2008
Approved
Approval ID
7375ab3f-a6fc-4601-9415-07b4f681cdef
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 10, 2023
Manufacturers
FDA
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
DUNS: 542977621
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
FOSAPREPITANT DIMEGLUMINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71731-5111
Application NumberANDA212143
Product Classification
M
Marketing Category
C73584
G
Generic Name
FOSAPREPITANT DIMEGLUMINE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 10, 2023
FDA Product Classification
INGREDIENTS (6)
FOSAPREPITANT DIMEGLUMINEActive
Quantity: 150 mg in 5 mL
Code: D35FM8T64X
Classification: ACTIR
EDETATE DISODIUMInactive
Quantity: 5.4 mg in 5 mL
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
LACTOSE MONOHYDRATEInactive
Quantity: 395 mg in 5 mL
Code: EWQ57Q8I5X
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 75 mg in 5 mL
Code: 6OZP39ZG8H
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT