azacitidine

Generic: azacitidine

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azacitidine
Generic Name azacitidine
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

azacitidine 100 mg/30mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-771
Product ID 63323-771_4becda8d-8042-4cf1-bef3-c0ec3c23eebe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207518
Listing Expiration 2026-12-31
Marketing Start 2017-03-16

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 63323771
Hyphenated Format 63323-771

Supplemental Identifiers

RxCUI
485246
UPC
0363323771393
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 ANDA207518 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/30mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-771-39) / 30 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

63323-771-39 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-771-39) / 30 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

azacitidine (100 mg/30mL)

Linked Drug Pages (1)

Azacitidine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "4becda8d-8042-4cf1-bef3-c0ec3c23eebe", "openfda": {"nui": ["N0000000233", "N0000175595"], "upc": ["0363323771393"], "unii": ["M801H13NRU"], "rxcui": ["485246"], "spl_set_id": ["3b594aba-e798-4105-b801-0b0d970747c1"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (63323-771-39)  / 30 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "63323-771-39", "marketing_start_date": "20170316"}], "brand_name": "Azacitidine", "product_id": "63323-771_4becda8d-8042-4cf1-bef3-c0ec3c23eebe", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "63323-771", "generic_name": "Azacitidine", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azacitidine", "active_ingredients": [{"name": "AZACITIDINE", "strength": "100 mg/30mL"}], "application_number": "ANDA207518", "marketing_category": "ANDA", "marketing_start_date": "20170316", "listing_expiration_date": "20261231"}