cytarabine
Cytarabine Injection(For Intravenous, Intrathecal and Subcutaneous Use Only)
Approved
Approval ID
9bc7f6c2-4b16-449b-b383-76106540206c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 22, 2023
Manufacturers
FDA
Sagent Pharmaceuticals
DUNS: 080579617
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 Code25021-223
Application NumberANDA211938
Product Classification
M
Marketing Category
C73584
G
Generic Name
cytarabine
Product Specifications
Route of AdministrationINTRAVENOUS, INTRATHECAL, SUBCUTANEOUS
Effective DateMay 22, 2023
FDA Product Classification
INGREDIENTS (4)
waterInactive
Code: 059QF0KO0R
Classification: IACT
cytarabineActive
Quantity: 100 mg in 1 mL
Code: 04079A1RDZ
Classification: ACTIB
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT