INQOVI

Product NDC
64842-0727
11-digit product format
648420727
Labeler code
64842
Product ID
64842-0727_12a04358-38a6-4d9d-965b-de70660f9ed0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEDAZURIDINE and DECITABINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Taiho Pharmaceutical Co., Ltd.
Application
NDA212576
Marketing category
NDA
Marketing start
2020-07-07
Substance
CEDAZURIDINE; DECITABINE
Active strength
100; 35 mg/1; mg/1
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
INQOVI
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEDAZURIDINE100 mg/1
DECITABINE35 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii39IS23Q1EW, 776B62CQ27
Rxcui2384457, 2384458, 2384464, 2384465

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba82e818-f876-42bf-ac8a-edb0f7670e1bProduct name120210121
871786fd-2c42-643c-2a8f-45c433540e89Product name920190709

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64842-0727-9INQOVI1 in 1 CARTONTABLET, FILM COATED113
64842-0727-9INQOVI5 in 1 BLISTER PACKTABLET, FILM COATED513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64842-0727-9EA - Each64842-0727506bb21d-677c-49d0-bf9f-56664de83e4512020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64842-0727INQOVI (CEDAZURIDINE AND DECITABINE) TABLET, FILM COATED [TAIHO PHARMACEUTICAL CO., LTD.]10Current NDC, Legacy NDC, 2 package rows20241206_91a0f80b-f865-4d06-a40d-4d148d99ee71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2384465{5 (cedazuridine 100 MG / decitabine 35 MG Oral Tablet [Inqovi]) } Pack [Inqovi 5 Tablet Pack]BPCK91a0f80b-f865-4d06-a40d-4d148d99ee7113
2384458{5 (cedazuridine 100 MG / decitabine 35 MG Oral Tablet) } PackGPCK91a0f80b-f865-4d06-a40d-4d148d99ee7113
2384458cedazuridine 100 MG / decitabine 35 MG (5) Oral Tablet PackPSN91a0f80b-f865-4d06-a40d-4d148d99ee7113
2384457cedazuridine 100 MG / decitabine 35 MG Oral TabletPSN91a0f80b-f865-4d06-a40d-4d148d99ee7113
2384464INQOVI 35 MG / 100 MG Oral TabletPSN91a0f80b-f865-4d06-a40d-4d148d99ee7113
2384465INQOVI 5 Tablet PackPSN91a0f80b-f865-4d06-a40d-4d148d99ee7113
2384464cedazuridine 100 MG / decitabine 35 MG Oral Tablet [Inqovi]SBD91a0f80b-f865-4d06-a40d-4d148d99ee7113
2384457cedazuridine 100 MG / decitabine 35 MG Oral TabletSCD91a0f80b-f865-4d06-a40d-4d148d99ee7113
2384458cedazuridine 100 MG / decitabine 35 MG (5) Oral Tablet PackSY91a0f80b-f865-4d06-a40d-4d148d99ee7113
2384464Inqovi 35 MG / 100 MG Oral TabletSY91a0f80b-f865-4d06-a40d-4d148d99ee7113
2384465Inqovi 5 Tablet PackSY91a0f80b-f865-4d06-a40d-4d148d99ee7113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64842-0727-9648420727091 BLISTER PACK in 1 CARTON (64842-0727-9) / 5 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2020-08-250000-00-00NoNoCurrent