Home NDC 11797-110 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N217865-001 DUVYZAT GIVINOSTAT HYDROCHLORIDE EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217865-001 7329689 2027-01-15 Drug substance, Drug product 2024-04-19 N217865-001 9421184 2032-02-03 U-3885 2024-04-19 N217865-001 9867799 2032-02-03 U-3885 2024-04-19 N217865-001 10688047 2036-10-28 U-3885 Drug product 2024-04-19 N217865-001 12606519 2040-05-03 Drug substance, Drug product 2026-05-07
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N217865-001 NCE 2029-03-21 N217865-001 ODE-473 2031-03-21
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 66 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N217865-001 7329689 2027-01-15 Drug substance, Drug product 2024-04-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217865-001 9421184 2032-02-03 U-3885 2024-04-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217865-001 9867799 2032-02-03 U-3885 2024-04-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217865-001 10688047 2036-10-28 U-3885 Drug product 2024-04-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217865-001 12606519 2040-05-03 Drug substance, Drug product 2026-05-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217865-001 7329689 2027-01-15 Drug substance, Drug product 2024-04-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217865-001 9421184 2032-02-03 U-3885 2024-04-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217865-001 9867799 2032-02-03 U-3885 2024-04-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217865-001 10688047 2036-10-28 U-3885 Drug product 2024-04-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217865-001 7329689 2026-01-15 Drug substance, Drug product 2024-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217865-001 9421184 2032-02-03 U-3885 2024-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217865-001 9867799 2032-02-03 U-3885 2024-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217865-001 10688047 2036-10-28 U-3885 Drug product 2024-04-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217865-001 7329689 2026-01-15 Drug substance, Drug product 2024-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217865-001 9421184 2032-02-03 U-3885 2024-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217865-001 9867799 2032-02-03 U-3885 2024-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217865-001 10688047 2036-10-28 U-3885 Drug product 2024-04-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217865-001 7329689 2026-01-15 Drug substance, Drug product 2024-04-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217865-001 9421184 2032-02-03 U-3885 2024-04-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217865-001 9867799 2032-02-03 U-3885 2024-04-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217865-001 10688047 2036-10-28 U-3885 Drug product 2024-04-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217865-001 7329689 2026-01-15 Drug substance, Drug product 2024-04-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217865-001 9421184 2032-02-03 U-3885 2024-04-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217865-001 9867799 2032-02-03 U-3885 2024-04-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217865-001 10688047 2036-10-28 U-3885 Drug product 2024-04-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217865-001 7329689 2026-01-15 Drug substance, Drug product 2024-04-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217865-001 9421184 2032-02-03 U-3885 2024-04-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217865-001 9867799 2032-02-03 U-3885 2024-04-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217865-001 10688047 2036-10-28 U-3885 Drug product 2024-04-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217865-001 7329689 2025-01-15 Drug substance, Drug product 2024-04-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217865-001 9421184 2032-02-03 U-3885 2024-04-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217865-001 9867799 2032-02-03 U-3885 2024-04-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217865-001 10688047 2036-10-28 U-3885 Drug product 2024-04-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217865-001 7329689 2025-01-15 Drug substance, Drug product 2024-04-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217865-001 9421184 2032-02-03 U-3885 2024-04-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217865-001 9867799 2032-02-03 U-3885 2024-04-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217865-001 10688047 2036-10-28 U-3885 Drug product 2024-04-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217865-001 7329689 2025-01-15 Drug substance, Drug product 2024-04-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217865-001 9421184 2032-02-03 U-3885 2024-04-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217865-001 9867799 2032-02-03 U-3885 2024-04-19 d8e5a09893c0…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base DUVYZAT
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GIVINOSTAT 8.86 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5P60F84FBH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2678894 Internal RxNorm lookup 2678900 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11797-110-01 DUVYZAT 140 mL in 1 BOTTLE SUSPENSION 140 2 11797-110-02 DUVYZAT 1 in 1 CARTON SUSPENSION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11797-110 DUVYZAT (GIVINOSTAT) SUSPENSION [ITALFARMACO SPA] 1 Current NDC, 2 package rows 20240405_1a28a3db-7880-4ac2-a2f2-2b4e362aafb6.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 11797-110-01 11797011001 140 mL in 1 BOTTLE 140 ml Historical 11797-110-02 11797011002 1 BOTTLE in 1 CARTON (11797-110-02) / 140 mL in 1 BOTTLE (11797-110-01) 1 bottle 2024-03-21 No No Current