Carboplatin
Carboplatin Injection, USPRx only
Approved
Approval ID
475caee0-15a6-4f0d-bca7-f3e472b323f7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 12, 2023
Manufacturers
FDA
Ingenus Pharmaceuticals, LLC
DUNS: 833250017
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Carboplatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50742-448
Application NumberANDA208487
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carboplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 12, 2023
FDA Product Classification
INGREDIENTS (2)
CARBOPLATINActive
Quantity: 600 mg in 60 mL
Code: BG3F62OND5
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Carboplatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50742-447
Application NumberANDA208487
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carboplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 12, 2023
FDA Product Classification
INGREDIENTS (2)
CARBOPLATINActive
Quantity: 450 mg in 45 mL
Code: BG3F62OND5
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT