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
bda7562e-7e6f-d661-f959-2184c4b51a13
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2022
Manufacturers
FDA
NorthStar RxLLC
DUNS: 830546433
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fosaprepitant
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-929
Application NumberANDA209965
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fosaprepitant
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 21, 2022
FDA Product Classification
INGREDIENTS (6)
Fosaprepitant DimeglumineActive
Quantity: 150 mg in 5 mL
Code: D35FM8T64X
Classification: ACTIR
Anhydrous LactoseInactive
Quantity: 375 mg in 5 mL
Code: 3SY5LH9PMK
Classification: IACT
Edetate SodiumInactive
Quantity: 5.4 mg in 5 mL
Code: MP1J8420LU
Classification: IACT
Polysorbate 80Inactive
Quantity: 75 mg in 5 mL
Code: 6OZP39ZG8H
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT