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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9512
Application NumberANDA074290
Product Classification
M
Marketing Category
C73584
G
Generic Name
Etoposide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 14, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9510
Application NumberANDA074290
Product Classification
M
Marketing Category
C73584
G
Generic Name
Etoposide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 14, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9511
Application NumberANDA074290
Product Classification
M
Marketing Category
C73584
G
Generic Name
Etoposide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 14, 2023
FDA Product Classification
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