decitabine

Generic: decitabine

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

decitabine 50 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9385
Product ID 0143-9385_4f8aacab-18de-4748-9552-76dcd9fb8e7a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213472
Listing Expiration 2026-12-31
Marketing Start 2022-04-15

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 01439385
Hyphenated Format 0143-9385

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 ANDA213472 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0143-9385-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0143-9385-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0143-9385-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Ingredients (1)

decitabine (50 mg/1)

Linked Drug Pages (1)

decitabine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "4f8aacab-18de-4748-9552-76dcd9fb8e7a", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["776B62CQ27"], "rxcui": ["636631"], "spl_set_id": ["8c5d6067-16a1-43ab-9e52-a33c600a5c44"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0143-9385-01)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE", "package_ndc": "0143-9385-01", "marketing_start_date": "20220415"}], "brand_name": "decitabine", "product_id": "0143-9385_4f8aacab-18de-4748-9552-76dcd9fb8e7a", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "0143-9385", "generic_name": "decitabine", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "decitabine", "active_ingredients": [{"name": "DECITABINE", "strength": "50 mg/1"}], "application_number": "ANDA213472", "marketing_category": "ANDA", "marketing_start_date": "20220415", "listing_expiration_date": "20261231"}