cytarabine

Generic: cytarabine

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cytarabine
Generic Name cytarabine
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRATHECAL INTRAVENOUS SUBCUTANEOUS
Active Ingredients

cytarabine 20 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-343
Product ID 68083-343_47628a16-dba0-4e55-ac61-70fc4d94730a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211937
Listing Expiration 2026-12-31
Marketing Start 2019-12-23

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 68083343
Hyphenated Format 68083-343

Supplemental Identifiers

RxCUI
1731355
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 ANDA211937 (source: ndc)
Routes
INTRATHECAL INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 5 VIAL, SINGLE-DOSE in 1 CARTON (68083-343-05) / 5 mL in 1 VIAL, SINGLE-DOSE (68083-343-01)
source: ndc

Packages (1)

68083-343-05 5 VIAL, SINGLE-DOSE in 1 CARTON (68083-343-05) / 5 mL in 1 VIAL, SINGLE-DOSE (68083-343-01)

Ingredients (1)

cytarabine (20 mg/mL)

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": "47628a16-dba0-4e55-ac61-70fc4d94730a", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["04079A1RDZ"], "rxcui": ["1731355"], "spl_set_id": ["7ab50348-ca78-46a5-aba6-c35b6b21fbfe"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 CARTON (68083-343-05)  / 5 mL in 1 VIAL, SINGLE-DOSE (68083-343-01)", "package_ndc": "68083-343-05", "marketing_start_date": "20191223"}], "brand_name": "Cytarabine", "product_id": "68083-343_47628a16-dba0-4e55-ac61-70fc4d94730a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "68083-343", "generic_name": "Cytarabine", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cytarabine", "active_ingredients": [{"name": "CYTARABINE", "strength": "20 mg/mL"}], "application_number": "ANDA211937", "marketing_category": "ANDA", "marketing_start_date": "20191223", "listing_expiration_date": "20261231"}