Etoposide
ETOPOSIDE INJECTION USP
Approved
Approval ID
4f850eb2-3542-43a0-90e8-bb37fa05cf15
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 9, 2020
Manufacturers
FDA
Accord Healthcare Inc.
DUNS: 604222237
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Etoposide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16729-114
Application NumberANDA074513
Product Classification
M
Marketing Category
C73584
G
Generic Name
Etoposide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 9, 2020
FDA Product Classification
INGREDIENTS (6)
ALCOHOLInactive
Quantity: 0.305 mL in 1 mL
Code: 3K9958V90M
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Quantity: 2 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 80 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 30 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
POLYETHYLENE GLYCOL 300Inactive
Quantity: 650 mg in 1 mL
Code: 5655G9Y8AQ
Classification: IACT
ETOPOSIDEActive
Quantity: 20 mg in 1 mL
Code: 6PLQ3CP4P3
Classification: ACTIB