cytarabine

Generic: cytarabine

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cytarabine
Generic Name cytarabine
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRATHECAL INTRAVENOUS SUBCUTANEOUS
Active Ingredients

cytarabine 2 g/20mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-109
Product ID 71288-109_695b376b-3972-4aef-b003-f1fb6fcde5b7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205696
Listing Expiration 2026-12-31
Marketing Start 2018-07-17

Pharmacologic Class

Established (EPC)
nucleoside metabolic inhibitor [epc]
Mechanism of Action
nucleic acid synthesis inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288109
Hyphenated Format 71288-109

Supplemental Identifiers

RxCUI
249364
UNII
04079A1RDZ
NUI
N0000000233 N0000175595

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cytarabine (source: ndc)
Generic Name cytarabine (source: ndc)
Application Number ANDA205696 (source: ndc)
Routes
INTRATHECAL INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 2 g/20mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-109-20) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

71288-109-20 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-109-20) / 20 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

cytarabine (2 g/20mL)

Linked Drug Pages (1)

Cytarabine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRATHECAL", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "695b376b-3972-4aef-b003-f1fb6fcde5b7", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["04079A1RDZ"], "rxcui": ["249364"], "spl_set_id": ["8105e590-fc7e-45b7-9604-c2d0d1be5eac"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-109-20)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-109-20", "marketing_start_date": "20180717"}], "brand_name": "Cytarabine", "product_id": "71288-109_695b376b-3972-4aef-b003-f1fb6fcde5b7", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "71288-109", "generic_name": "Cytarabine", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cytarabine", "active_ingredients": [{"name": "CYTARABINE", "strength": "2 g/20mL"}], "application_number": "ANDA205696", "marketing_category": "ANDA", "marketing_start_date": "20180717", "listing_expiration_date": "20261231"}