azacitidine

Generic: azacitidine

Labeler: reliance life sciences private limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azacitidine
Generic Name azacitidine
Labeler reliance life sciences private limited
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

azacitidine 100 mg/1

Manufacturer
Reliance Life Sciences Private Limited

Identifiers & Regulatory

Product NDC 58458-002
Product ID 58458-002_36422686-af0f-a4e1-e063-6294a90a1b44
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217453
Listing Expiration 2026-12-31
Marketing Start 2025-07-30

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 58458002
Hyphenated Format 58458-002

Supplemental Identifiers

RxCUI
485246
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 ANDA217453 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (58458-002-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS
source: ndc

Packages (1)

58458-002-02 1 VIAL, GLASS in 1 CARTON (58458-002-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS

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": "36422686-af0f-a4e1-e063-6294a90a1b44", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["M801H13NRU"], "rxcui": ["485246"], "spl_set_id": ["5804d999-96eb-4fd1-b7d8-de7867c5f1d6"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Reliance Life Sciences Private Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (58458-002-02)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS", "package_ndc": "58458-002-02", "marketing_start_date": "20250730"}], "brand_name": "Azacitidine", "product_id": "58458-002_36422686-af0f-a4e1-e063-6294a90a1b44", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "58458-002", "generic_name": "Azacitidine", "labeler_name": "Reliance Life Sciences Private Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azacitidine", "active_ingredients": [{"name": "AZACITIDINE", "strength": "100 mg/1"}], "application_number": "ANDA217453", "marketing_category": "ANDA", "marketing_start_date": "20250730", "listing_expiration_date": "20261231"}