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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

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Carboplatin - FDA Drug Approval Details