FDA.reportPublic FDA data

DUVYZAT

Product NDC
11797-110
11-digit product format
117970110
Labeler code
11797
Product ID
11797-110_23b3f0a7-bf0e-4221-a534-145f6c4ea8b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
givinostat
Dosage form
SUSPENSION
Route
ORAL
Labeler
Italfarmaco SPA
Application
NDA217865
Marketing category
NDA
Marketing start
2024-03-21
Substance
GIVINOSTAT
Active strength
8.86 mg/mL
Pharmacologic classes
Cytochrome P450 3A4 Inhibitors [MoA], Histone Deacetylase Inhibitor [EPC], Histone Deacetylase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GIVINOSTAT8.86 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5P60F84FBH
Rxcui2678894, 2678900

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dd16300d-bcef-4a0a-b2ad-e31c521d1185Product name120250124
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11797-110-01DUVYZAT140 mL in 1 BOTTLESUSPENSION1402
11797-110-02DUVYZAT1 in 1 CARTONSUSPENSION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11797-110-01ML - Milliliter11797-1108c614108-c78e-4f6f-944e-f38e1f619cb712024-07-12
11797-110-02ML - Milliliter11797-110bdd484e2-50f8-4730-baf0-57371b9128c612024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11797-110DUVYZAT (GIVINOSTAT) SUSPENSION [ITALFARMACO SPA]1Current NDC, 2 package rows20240405_1a28a3db-7880-4ac2-a2f2-2b4e362aafb6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2678900Duvyzat 8.86 MG/mL Oral SuspensionPSN1a28a3db-7880-4ac2-a2f2-2b4e362aafb62
2678894givinostat 8.86 MG/mL Oral SuspensionPSN1a28a3db-7880-4ac2-a2f2-2b4e362aafb62
2678900givinostat 8.86 MG/ML Oral Suspension [Duvyzat]SBD1a28a3db-7880-4ac2-a2f2-2b4e362aafb62
2678894givinostat 8.86 MG/ML Oral SuspensionSCD1a28a3db-7880-4ac2-a2f2-2b4e362aafb62
2678900Duvyzat 8.86 MG/mL (equivalent to givinostat HCl monohydrate) Oral SuspensionSY1a28a3db-7880-4ac2-a2f2-2b4e362aafb62
2678900Duvyzat 8.86 MG/mL Oral SuspensionSY1a28a3db-7880-4ac2-a2f2-2b4e362aafb62
2678894givinostat 8.86 MG/mL (equivalent to givinostat HCl monohydrate) Oral SuspensionSY1a28a3db-7880-4ac2-a2f2-2b4e362aafb62
2678894givinostat 8.86 MG/mL Oral SuspensionSY1a28a3db-7880-4ac2-a2f2-2b4e362aafb62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11797-110-0111797011001140 mL in 1 BOTTLE140 mlHistorical
11797-110-02117970110021 BOTTLE in 1 CARTON (11797-110-02) / 140 mL in 1 BOTTLE (11797-110-01) 1 bottle2024-03-21NoNoHistorical