decitabine

Generic: decitabine

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name decitabine
Generic Name decitabine
Labeler mylan institutional llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

decitabine 50 mg/20mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-316
Product ID 67457-316_b47bee52-7718-749c-e053-2a95a90a0f38
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204607
Listing Expiration 2026-12-31
Marketing Start 2018-10-10

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 67457316
Hyphenated Format 67457-316

Supplemental Identifiers

RxCUI
636631
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 ANDA204607 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/20mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (67457-316-25) / 20 mL in 1 VIAL
source: ndc

Packages (1)

67457-316-25 1 VIAL in 1 CARTON (67457-316-25) / 20 mL in 1 VIAL

Ingredients (1)

decitabine (50 mg/20mL)

Linked Drug Pages (1)

Decitabine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "b47bee52-7718-749c-e053-2a95a90a0f38", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["776B62CQ27"], "rxcui": ["636631"], "spl_set_id": ["447a9fbd-106d-4ff6-8fd0-bb38a8c90e17"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (67457-316-25)  / 20 mL in 1 VIAL", "package_ndc": "67457-316-25", "marketing_start_date": "20181010"}], "brand_name": "Decitabine", "product_id": "67457-316_b47bee52-7718-749c-e053-2a95a90a0f38", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "67457-316", "generic_name": "decitabine", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Decitabine", "active_ingredients": [{"name": "DECITABINE", "strength": "50 mg/20mL"}], "application_number": "ANDA204607", "marketing_category": "ANDA", "marketing_start_date": "20181010", "listing_expiration_date": "20261231"}