onureg

Generic: azacitidine

Labeler: celgene corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name onureg
Generic Name azacitidine
Labeler celgene corporation
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

azacitidine 200 mg/1

Manufacturer
Celgene Corporation

Identifiers & Regulatory

Product NDC 59572-730
Product ID 59572-730_d8188fe8-50cb-4e5d-ad48-f27d068a89f6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214120
Listing Expiration 2026-12-31
Marketing Start 2020-09-01

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 59572730
Hyphenated Format 59572-730

Supplemental Identifiers

RxCUI
2396764 2396770 2396772 2396774
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 onureg (source: ndc)
Generic Name azacitidine (source: ndc)
Application Number NDA214120 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 7 TABLET, FILM COATED in 1 BLISTER PACK (59572-730-07)
  • 14 TABLET, FILM COATED in 1 BOTTLE (59572-730-14)
source: ndc

Packages (2)

59572-730-07 7 TABLET, FILM COATED in 1 BLISTER PACK (59572-730-07) 59572-730-14 14 TABLET, FILM COATED in 1 BOTTLE (59572-730-14)

Ingredients (1)

azacitidine (200 mg/1)

Linked Drug Pages (1)

ONUREG ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d8188fe8-50cb-4e5d-ad48-f27d068a89f6", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["M801H13NRU"], "rxcui": ["2396764", "2396770", "2396772", "2396774"], "spl_set_id": ["0e95e33f-8aba-4f19-b332-2416580d358b"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Celgene Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "7 TABLET, FILM COATED in 1 BLISTER PACK (59572-730-07)", "package_ndc": "59572-730-07", "marketing_start_date": "20201218"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE (59572-730-14)", "package_ndc": "59572-730-14", "marketing_start_date": "20200901"}], "brand_name": "ONUREG", "product_id": "59572-730_d8188fe8-50cb-4e5d-ad48-f27d068a89f6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "59572-730", "generic_name": "azacitidine", "labeler_name": "Celgene Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ONUREG", "active_ingredients": [{"name": "AZACITIDINE", "strength": "200 mg/1"}], "application_number": "NDA214120", "marketing_category": "NDA", "marketing_start_date": "20200901", "listing_expiration_date": "20261231"}