Cytarabine
Cytarabine Injection
Approved
Approval ID
e3a8c0e9-19ed-49b7-8464-11e8806f47fd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 7, 2025
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 Code61703-155
Application NumberANDA075383
Product Classification
M
Marketing Category
C73584
G
Generic Name
CYTARABINE
Product Specifications
Route of AdministrationINTRAVENOUS, INTRATHECAL, SUBCUTANEOUS
Effective DateApril 7, 2025
FDA Product Classification
INGREDIENTS (4)
CYTARABINEActive
Quantity: 100 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
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/7/2025
Boxed Warning section
LOINC: 34066-1Updated: 4/7/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 4/7/2025
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 4/7/2025
ADVERSE REACTIONS SECTION
LOINC: 34084-4Updated: 4/7/2025
DESCRIPTION SECTION
LOINC: 34089-3Updated: 4/7/2025
CLINICAL PHARMACOLOGY SECTION
LOINC: 34090-1Updated: 4/7/2025
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 4/7/2025
WARNINGS SECTION
LOINC: 34071-1Updated: 4/7/2025
PRECAUTIONS SECTION
LOINC: 42232-9Updated: 4/7/2025
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 4/7/2025
OVERDOSAGE SECTION
LOINC: 34088-5Updated: 4/7/2025
DISPOSAL AND WASTE HANDLING
LOINC: 69763-1Updated: 4/7/2025
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 4/7/2025
STORAGE AND HANDLING SECTION
LOINC: 44425-7Updated: 4/7/2025
REFERENCES SECTION
LOINC: 34093-5Updated: 4/7/2025