inqovi

Generic: cedazuridine and decitabine

Labeler: taiho pharmaceutical co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name inqovi
Generic Name cedazuridine and decitabine
Labeler taiho pharmaceutical co., ltd.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cedazuridine 100 mg/1, decitabine 35 mg/1

Manufacturer
Taiho Pharmaceutical Co., Ltd.

Identifiers & Regulatory

Product NDC 64842-0727
Product ID 64842-0727_12a04358-38a6-4d9d-965b-de70660f9ed0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212576
Listing Expiration 2026-12-31
Marketing Start 2020-07-07

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 648420727
Hyphenated Format 64842-0727

Supplemental Identifiers

RxCUI
2384457 2384458 2384464 2384465
UNII
39IS23Q1EW 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 inqovi (source: ndc)
Generic Name cedazuridine and decitabine (source: ndc)
Application Number NDA212576 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
  • 35 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (64842-0727-9) / 5 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

64842-0727-9 1 BLISTER PACK in 1 CARTON (64842-0727-9) / 5 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (2)

cedazuridine (100 mg/1) decitabine (35 mg/1)

Linked Drug Pages (1)

INQOVI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "12a04358-38a6-4d9d-965b-de70660f9ed0", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["39IS23Q1EW", "776B62CQ27"], "rxcui": ["2384457", "2384458", "2384464", "2384465"], "spl_set_id": ["91a0f80b-f865-4d06-a40d-4d148d99ee71"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Taiho Pharmaceutical Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (64842-0727-9)  / 5 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "64842-0727-9", "marketing_start_date": "20200825"}], "brand_name": "INQOVI", "product_id": "64842-0727_12a04358-38a6-4d9d-965b-de70660f9ed0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "64842-0727", "generic_name": "CEDAZURIDINE and DECITABINE", "labeler_name": "Taiho Pharmaceutical Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "INQOVI", "active_ingredients": [{"name": "CEDAZURIDINE", "strength": "100 mg/1"}, {"name": "DECITABINE", "strength": "35 mg/1"}], "application_number": "NDA212576", "marketing_category": "NDA", "marketing_start_date": "20200707", "listing_expiration_date": "20261231"}