Package 11797-110-02

Brand: duvyzat

Generic: givinostat
NDC Package

Package Facts

Identity

Package NDC 11797-110-02
Digits Only 1179711002
Product NDC 11797-110
Description

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

Marketing

Marketing Status
Marketed Since 2024-03-21
Brand duvyzat
Generic givinostat
Sample Package No

Linked Drug Pages (1)

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"}