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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

2d30d839-bb88-46ce-a9ed-66fe32a12a7a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 7, 2025

Manufacturers
FDA

BluePoint Laboratories

DUNS: 985523874

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 Code68001-523
Application NumberANDA214616
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fosaprepitant dimeglumine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 7, 2025
FDA Product Classification

INGREDIENTS (6)

EDETATE DISODIUMInactive
Quantity: 5.4 mg in 5 mL
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
FOSAPREPITANT DIMEGLUMINEActive
Quantity: 150 mg in 5 mL
Code: D35FM8T64X
Classification: ACTIR
ANHYDROUS LACTOSEInactive
Quantity: 375 mg in 5 mL
Code: 3SY5LH9PMK
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 75 mg in 5 mL
Code: 6OZP39ZG8H
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/30/2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fosaprepitant for Injection label 032025Fosaprepitant for Injection Carton rev 032025Fosaprepitant for Injection 150 mg per vial - Vial Carton Label

carton

Fosaprepitant for Injection 150 mg per vial - Vial Label

label

DESCRIPTION SECTION

LOINC: 34089-3Updated: 9/30/2022

11 DESCRIPTION

Fosaprepitant for injection is a sterile, lyophilized formulation containing fosaprepitant dimeglumine, a prodrug of aprepitant, a substance P/neurokinin-1 (NK 1) receptor antagonist, an antiemetic agent, chemically described as 1-Deoxy-1-(methylamino)-D-glucitol[3-[[(2 R,3 S)-2-[(1 R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-2,5-dihydro-5-oxo-1 H-1,2,4-triazol-1-yl]phosphonate (2:1) (salt).
Its empirical formula is C 23H 22F 7N 4O 6P ⋅ 2(C 7H 17NO 5) and its structural formula is:

structure.jpg

Fosaprepitant dimeglumine is a white to light brown powder with a molecular weight of 1004.83. It is soluble in water and methanol.
Each vial of fosaprepitant for injection for administration as an intravenous infusion contains 150 mg of fosaprepitant (equivalent to 245.3 mg of fosaprepitant dimeglumine) and the following inactive ingredients: edetate disodium (5.4 mg), lactose anhydrous (375 mg), polysorbate 80 (75 mg), sodium hydroxide and/or hydrochloric acid (for pH adjustment).

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Fosaprepitant - FDA Drug Approval Details