nelarabine

Generic: nelarabine

Labeler: shorla oncology inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nelarabine
Generic Name nelarabine
Labeler shorla oncology inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

nelarabine 5 mg/mL

Manufacturer
Shorla Oncology Inc.

Identifiers & Regulatory

Product NDC 81927-111
Product ID 81927-111_f21b358e-9f41-4dc3-858f-b55f9a8af715
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214809
Listing Expiration 2026-12-31
Marketing Start 2023-03-15

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 81927111
Hyphenated Format 81927-111

Supplemental Identifiers

RxCUI
603566 2722411
UPC
0381927111018
UNII
60158CV180
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 nelarabine (source: ndc)
Generic Name nelarabine (source: ndc)
Application Number ANDA214809 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (81927-111-01) / 50 mL in 1 VIAL, SINGLE-DOSE
  • 6 VIAL, SINGLE-DOSE in 1 CARTON (81927-111-06) / 50 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

81927-111-01 1 VIAL, SINGLE-DOSE in 1 CARTON (81927-111-01) / 50 mL in 1 VIAL, SINGLE-DOSE 81927-111-06 6 VIAL, SINGLE-DOSE in 1 CARTON (81927-111-06) / 50 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

nelarabine (5 mg/mL)

Linked Drug Pages (1)

nelarabine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "f21b358e-9f41-4dc3-858f-b55f9a8af715", "openfda": {"nui": ["N0000000233", "N0000175595"], "upc": ["0381927111018"], "unii": ["60158CV180"], "rxcui": ["603566", "2722411"], "spl_set_id": ["fc401b06-4e3b-413e-a854-3e031c433862"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Shorla Oncology Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (81927-111-01)  / 50 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "81927-111-01", "marketing_start_date": "20230315"}, {"sample": false, "description": "6 VIAL, SINGLE-DOSE in 1 CARTON (81927-111-06)  / 50 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "81927-111-06", "marketing_start_date": "20230315"}], "brand_name": "nelarabine", "product_id": "81927-111_f21b358e-9f41-4dc3-858f-b55f9a8af715", "dosage_form": "INJECTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "81927-111", "generic_name": "nelarabine", "labeler_name": "Shorla Oncology Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "nelarabine", "active_ingredients": [{"name": "NELARABINE", "strength": "5 mg/mL"}], "application_number": "ANDA214809", "marketing_category": "ANDA", "marketing_start_date": "20230315", "listing_expiration_date": "20261231"}