decitabine

Generic: decitabine

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name decitabine
Generic Name decitabine
Labeler bluepoint laboratories
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

decitabine 50 mg/10mL

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-642
Product ID 68001-642_3ff1337b-204f-2c46-e063-6394a90a4ebe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215355
Listing Expiration 2026-12-31
Marketing Start 2025-05-01

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 68001642
Hyphenated Format 68001-642

Supplemental Identifiers

RxCUI
636631
UPC
0368001642415
UNII
776B62CQ27
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 decitabine (source: ndc)
Generic Name decitabine (source: ndc)
Application Number ANDA215355 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/10mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-642-41) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

68001-642-41 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-642-41) / 10 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

decitabine (50 mg/10mL)

Linked Drug Pages (1)

Decitabine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3ff1337b-204f-2c46-e063-6394a90a4ebe", "openfda": {"nui": ["N0000000233", "N0000175595"], "upc": ["0368001642415"], "unii": ["776B62CQ27"], "rxcui": ["636631"], "spl_set_id": ["de303068-589e-4e0a-90ed-e60b2c1a2b56"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (68001-642-41)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "68001-642-41", "marketing_start_date": "20250501"}], "brand_name": "Decitabine", "product_id": "68001-642_3ff1337b-204f-2c46-e063-6394a90a4ebe", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "68001-642", "generic_name": "Decitabine", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Decitabine", "active_ingredients": [{"name": "DECITABINE", "strength": "50 mg/10mL"}], "application_number": "ANDA215355", "marketing_category": "ANDA", "marketing_start_date": "20250501", "listing_expiration_date": "20261231"}