Fosaprepitant
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Approved
Approval ID
47177d8c-389f-46e8-aadf-5b69ceaeaf8b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 20, 2020
Manufacturers
FDA
CELLTRION USA, INC.
DUNS: 116587378
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 Code72606-569
Application NumberANDA211624
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fosaprepitant Dimeglumine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 15, 2020
FDA Product Classification
INGREDIENTS (6)
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
POLYSORBATE 80Inactive
Quantity: 75 mg in 5 mL
Code: 6OZP39ZG8H
Classification: IACT
ANHYDROUS LACTOSEInactive
Quantity: 375 mg in 5 mL
Code: 3SY5LH9PMK
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT