decitabine

Generic: decitabine

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

Drug Facts

Product Profile

Brand Name decitabine
Generic Name decitabine
Labeler nivagen pharmaceuticals, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

decitabine 50 mg/20mL

Manufacturer
Nivagen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 75834-190
Product ID 75834-190_e20c2038-e61d-4c04-8b35-f2ff37a1b8d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212117
Listing Expiration 2026-12-31
Marketing Start 2020-12-17

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 75834190
Hyphenated Format 75834-190

Supplemental Identifiers

RxCUI
636631
UPC
0375834190013
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 ANDA212117 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/20mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (75834-190-01) / 20 mL in 1 VIAL
source: ndc

Packages (1)

75834-190-01 1 VIAL in 1 CARTON (75834-190-01) / 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": "e20c2038-e61d-4c04-8b35-f2ff37a1b8d5", "openfda": {"nui": ["N0000000233", "N0000175595"], "upc": ["0375834190013"], "unii": ["776B62CQ27"], "rxcui": ["636631"], "spl_set_id": ["150537a8-10ac-422d-bf33-68b1a408e566"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Nivagen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (75834-190-01)  / 20 mL in 1 VIAL", "package_ndc": "75834-190-01", "marketing_start_date": "20201217"}], "brand_name": "DECITABINE", "product_id": "75834-190_e20c2038-e61d-4c04-8b35-f2ff37a1b8d5", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "75834-190", "generic_name": "decitabine", "labeler_name": "Nivagen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DECITABINE", "active_ingredients": [{"name": "DECITABINE", "strength": "50 mg/20mL"}], "application_number": "ANDA212117", "marketing_category": "ANDA", "marketing_start_date": "20201217", "listing_expiration_date": "20261231"}