Cladribine
Cladribine Injection, USP
Approved
Approval ID
a2592a9b-bca6-4a5a-89c2-855a0634d5fe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 31, 2019
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CLADRIBINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-140
Application NumberANDA076571
Product Classification
M
Marketing Category
C73584
G
Generic Name
CLADRIBINE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 31, 2019
FDA Product Classification
INGREDIENTS (4)
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
CLADRIBINEActive
Quantity: 1 mg in 1 mL
Code: 47M74X9YT5
Classification: ACTIB
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT