Cytarabine
Cytarabine Injection
Approved
Approval ID
bc2fa221-ea56-48b8-8304-42cd81b8463b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 9, 2022
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CYTARABINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61703-305
Application NumberANDA071868
Product Classification
M
Marketing Category
C73584
G
Generic Name
CYTARABINE
Product Specifications
Route of AdministrationINTRAVENOUS, INTRATHECAL, SUBCUTANEOUS
Effective DateDecember 9, 2022
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Quantity: 6.8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
CYTARABINEActive
Quantity: 20 mg in 1 mL
Code: 04079A1RDZ
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT