duvyzat

Generic: givinostat

Labeler: italfarmaco spa
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name duvyzat
Generic Name givinostat
Labeler italfarmaco spa
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

givinostat 8.86 mg/mL

Manufacturer
Italfarmaco SPA

Identifiers & Regulatory

Product NDC 11797-110
Product ID 11797-110_23b3f0a7-bf0e-4221-a534-145f6c4ea8b7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217865
Listing Expiration 2027-12-31
Marketing Start 2024-03-21

Pharmacologic Class

Established (EPC)
histone deacetylase inhibitor [epc]
Mechanism of Action
histone deacetylase inhibitors [moa] cytochrome p450 3a4 inhibitors [moa] organic cation transporter 2 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 11797110
Hyphenated Format 11797-110

Supplemental Identifiers

RxCUI
2678894 2678900
UPC
0311797110019
UNII
5P60F84FBH
NUI
N0000175588 N0000175071 N0000182141 N0000187061

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 duvyzat (source: ndc)
Generic Name givinostat (source: ndc)
Application Number NDA217865 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8.86 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (11797-110-02) / 140 mL in 1 BOTTLE (11797-110-01)
source: ndc

Packages (1)

11797-110-02 1 BOTTLE in 1 CARTON (11797-110-02) / 140 mL in 1 BOTTLE (11797-110-01)

Ingredients (1)

givinostat (8.86 mg/mL)

Linked Drug Pages (1)

DUVYZAT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "23b3f0a7-bf0e-4221-a534-145f6c4ea8b7", "openfda": {"nui": ["N0000175588", "N0000175071", "N0000182141", "N0000187061"], "upc": ["0311797110019"], "unii": ["5P60F84FBH"], "rxcui": ["2678894", "2678900"], "spl_set_id": ["1a28a3db-7880-4ac2-a2f2-2b4e362aafb6"], "pharm_class_epc": ["Histone Deacetylase Inhibitor [EPC]"], "pharm_class_moa": ["Histone Deacetylase Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]"], "manufacturer_name": ["Italfarmaco SPA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (11797-110-02)  / 140 mL in 1 BOTTLE (11797-110-01)", "package_ndc": "11797-110-02", "marketing_start_date": "20240321"}], "brand_name": "DUVYZAT", "product_id": "11797-110_23b3f0a7-bf0e-4221-a534-145f6c4ea8b7", "dosage_form": "SUSPENSION", "pharm_class": ["Cytochrome P450 3A4 Inhibitors [MoA]", "Histone Deacetylase Inhibitor [EPC]", "Histone Deacetylase Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]"], "product_ndc": "11797-110", "generic_name": "givinostat", "labeler_name": "Italfarmaco SPA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DUVYZAT", "active_ingredients": [{"name": "GIVINOSTAT", "strength": "8.86 mg/mL"}], "application_number": "NDA217865", "marketing_category": "NDA", "marketing_start_date": "20240321", "listing_expiration_date": "20271231"}