EMEND
These highlights do not include all the information needed to use EMEND FOR INJECTION safely and effectively. See full prescribing information for EMEND FOR INJECTION. EMEND (fosaprepitant) for injection, for intravenous useInitial U.S. Approval: 2008
Approved
Approval ID
44f634f4-b794-4d55-8ab7-037fdef8ff0f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 26, 2018
Manufacturers
FDA
Merck Sharp & Dohme Corp.
DUNS: 001317601
Products 2
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 Code0006-3941
Application NumberNDA022023
Product Classification
M
Marketing Category
C73594
G
Generic Name
FOSAPREPITANT DIMEGLUMINE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 26, 2018
FDA Product Classification
INGREDIENTS (6)
ANHYDROUS LACTOSEInactive
Quantity: 375 mg in 5 mL
Code: 3SY5LH9PMK
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 75 mg in 5 mL
Code: 6OZP39ZG8H
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
FOSAPREPITANT DIMEGLUMINEActive
Quantity: 150 mg in 5 mL
Code: D35FM8T64X
Classification: ACTIR
EDETATE DISODIUMInactive
Quantity: 18.8 mg in 5 mL
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
FOSAPREPITANT DIMEGLUMINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0006-3884
Application NumberNDA022023
Product Classification
M
Marketing Category
C73594
G
Generic Name
FOSAPREPITANT DIMEGLUMINE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 26, 2018
FDA Product Classification
INGREDIENTS (6)
ANHYDROUS LACTOSEInactive
Quantity: 287.5 mg in 5 mL
Code: 3SY5LH9PMK
Classification: IACT
FOSAPREPITANT DIMEGLUMINEActive
Quantity: 115 mg in 5 mL
Code: D35FM8T64X
Classification: ACTIR
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 14.4 mg in 5 mL
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 57.5 mg in 5 mL
Code: 6OZP39ZG8H
Classification: IACT