azacitidine

Generic: azacitidine for

Labeler: pilnova pharma inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azacitidine
Generic Name azacitidine for
Labeler pilnova pharma inc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

azacitidine 100 mg/1

Manufacturer
Pilnova Pharma Inc

Identifiers & Regulatory

Product NDC 83774-102
Product ID 83774-102_a531999b-865f-4e84-bd6f-818f8f377a3c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207518
Listing Expiration 2026-12-31
Marketing Start 2024-03-14

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 83774102
Hyphenated Format 83774-102

Supplemental Identifiers

RxCUI
485246
UPC
0383774102010
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 for (source: ndc)
Application Number ANDA207518 (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 (83774-102-01)
source: ndc

Packages (1)

83774-102-01 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (83774-102-01)

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": "a531999b-865f-4e84-bd6f-818f8f377a3c", "openfda": {"nui": ["N0000000233", "N0000175595"], "upc": ["0383774102010"], "unii": ["M801H13NRU"], "rxcui": ["485246"], "spl_set_id": ["0095c67b-42f3-47e6-92db-f77843727bca"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Pilnova Pharma Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (83774-102-01)", "package_ndc": "83774-102-01", "marketing_start_date": "20240314"}], "brand_name": "AZACITIDINE", "product_id": "83774-102_a531999b-865f-4e84-bd6f-818f8f377a3c", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "83774-102", "generic_name": "azacitidine for", "labeler_name": "Pilnova Pharma Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AZACITIDINE", "active_ingredients": [{"name": "AZACITIDINE", "strength": "100 mg/1"}], "application_number": "ANDA207518", "marketing_category": "ANDA", "marketing_start_date": "20240314", "listing_expiration_date": "20261231"}