azacitidine

Generic: azacitidine

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name azacitidine
Generic Name azacitidine
Labeler bluepoint laboratories
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

azacitidine 100 mg/1

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-313
Product ID 68001-313_36080e4e-a0fe-ba15-e063-6394a90aed5c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208216
Marketing Start 2017-07-01
Marketing End 2026-12-31

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 68001313
Hyphenated Format 68001-313

Supplemental Identifiers

RxCUI
485246
UPC
0368001313568
UNII
M801H13NRU
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 azacitidine (source: ndc)
Generic Name azacitidine (source: ndc)
Application Number NDA208216 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (68001-313-56)
source: ndc

Packages (1)

68001-313-56 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (68001-313-56)

Ingredients (1)

azacitidine (100 mg/1)

Linked Drug Pages (1)

Azacitidine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "36080e4e-a0fe-ba15-e063-6394a90aed5c", "openfda": {"nui": ["N0000000233", "N0000175595"], "upc": ["0368001313568"], "unii": ["M801H13NRU"], "rxcui": ["485246"], "spl_set_id": ["5f0f9ee3-a5b1-4a25-a34c-7f38c8433f4a"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (68001-313-56)", "package_ndc": "68001-313-56", "marketing_end_date": "20261231", "marketing_start_date": "20170701"}], "brand_name": "Azacitidine", "product_id": "68001-313_36080e4e-a0fe-ba15-e063-6394a90aed5c", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "68001-313", "generic_name": "Azacitidine", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azacitidine", "active_ingredients": [{"name": "AZACITIDINE", "strength": "100 mg/1"}], "application_number": "NDA208216", "marketing_category": "NDA", "marketing_end_date": "20261231", "marketing_start_date": "20170701"}