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
NDC Product Code61703-155
Application NumberANDA075383
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, INTRATHECAL, SUBCUTANEOUS
Effective DateApril 7, 2025
Generic NameCYTARABINE
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