Etoposide
ETOPOSIDE INJECTION, USP
Approved
Approval ID
6dfedeff-a807-4405-a482-2f7109ad31c9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 14, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Etoposide
PRODUCT DETAILS
NDC Product Code0143-9512
Application NumberANDA074290
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateSeptember 14, 2023
Generic NameEtoposide
INGREDIENTS (6)
ETOPOSIDEActive
Quantity: 20 mg in 1 mL
Code: 6PLQ3CP4P3
Classification: ACTIB
BENZYL ALCOHOLInactive
Quantity: 30 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
ALCOHOLInactive
Quantity: 0.305 mL in 1 mL
Code: 3K9958V90M
Classification: IACT
POLYETHYLENE GLYCOL 300Inactive
Quantity: 650 mg in 1 mL
Code: 5655G9Y8AQ
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 2 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 80 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
Etoposide
PRODUCT DETAILS
NDC Product Code0143-9510
Application NumberANDA074290
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateSeptember 14, 2023
Generic NameEtoposide
INGREDIENTS (6)
ETOPOSIDEActive
Quantity: 20 mg in 1 mL
Code: 6PLQ3CP4P3
Classification: ACTIB
BENZYL ALCOHOLInactive
Quantity: 30 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
ALCOHOLInactive
Quantity: 0.305 mL in 1 mL
Code: 3K9958V90M
Classification: IACT
POLYETHYLENE GLYCOL 300Inactive
Quantity: 650 mg in 1 mL
Code: 5655G9Y8AQ
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 2 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 80 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
Etoposide
PRODUCT DETAILS
NDC Product Code0143-9511
Application NumberANDA074290
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateSeptember 14, 2023
Generic NameEtoposide
INGREDIENTS (6)
ALCOHOLInactive
Quantity: 0.305 mL in 1 mL
Code: 3K9958V90M
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 30 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 2 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
ETOPOSIDEActive
Quantity: 20 mg in 1 mL
Code: 6PLQ3CP4P3
Classification: ACTIB
POLYSORBATE 80Inactive
Quantity: 80 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL 300Inactive
Quantity: 650 mg in 1 mL
Code: 5655G9Y8AQ
Classification: IACT