azacitidine

Generic: azacitidine

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azacitidine
Generic Name azacitidine
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

azacitidine 100 mg/1

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-153
Product ID 71288-153_6b7269e4-757b-4209-b142-d3a2ba369bd4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212128
Listing Expiration 2026-12-31
Marketing Start 2020-11-02

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 71288153
Hyphenated Format 71288-153

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 ANDA212128 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-153-95) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

71288-153-95 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-153-95) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

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": "6b7269e4-757b-4209-b142-d3a2ba369bd4", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["M801H13NRU"], "rxcui": ["485246"], "spl_set_id": ["3b96b508-046b-49ae-aefe-6d39c89a1d0e"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-153-95)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-153-95", "marketing_start_date": "20201102"}], "brand_name": "Azacitidine", "product_id": "71288-153_6b7269e4-757b-4209-b142-d3a2ba369bd4", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "71288-153", "generic_name": "Azacitidine", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azacitidine", "active_ingredients": [{"name": "AZACITIDINE", "strength": "100 mg/1"}], "application_number": "ANDA212128", "marketing_category": "ANDA", "marketing_start_date": "20201102", "listing_expiration_date": "20261231"}