Home NDC 0078-0651 FARYDAK
Product NDC 0078-0651
11-digit product format 000780651
Labeler code 0078
Product ID 0078-0651_8d8f5dd5-879b-4f1a-a239-74ae9eb358fc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name panobinostat
Dosage form CAPSULE
Route ORAL
Labeler Novartis Pharmaceuticals Corporation
Application NDA205353
Marketing category NDA
Marketing start 2015-02-23
Marketing end 2022-12-31
Substance PANOBINOSTAT LACTATE
Active strength 15 mg/1
Pharmacologic classes Histone Deacetylase Inhibitor [EPC],Histone Deacetylase Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0078-0651-06 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0078-0651-06 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0078-0651-06 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0078-0651-06 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0078-0651-06 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0078-0651-06 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0078-0651-06 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0078-0651-06 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0078-0651-06 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0078-0651-06 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0078-0651-06 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0078-0651-06 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205353-001 FARYDAK PANOBINOSTAT LACTATE EQ 10MG BASE CAPSULE / ORAL RLD 2015-02-23 N205353-002 FARYDAK PANOBINOSTAT LACTATE EQ 15MG BASE CAPSULE / ORAL RLD 2015-02-23 N205353-003 FARYDAK PANOBINOSTAT LACTATE EQ 20MG BASE CAPSULE / ORAL RLD 2015-02-23
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205353-001 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 N205353-001 8883842 2028-06-13 U-1669 2015-03-20 N205353-002 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 N205353-002 8883842 2028-06-13 U-1669 2015-03-20 N205353-003 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 N205353-003 8883842 2028-06-13 U-1669 2015-03-20
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.
Product history page 1 of 4 · 132 observed 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 2026-10-15 13:18:30 2026-09 N205353-001 FARYDAK EQ 10MG BASE CAPSULE / ORAL RLD 2015-02-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205353-002 FARYDAK EQ 15MG BASE CAPSULE / ORAL RLD 2015-02-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205353-003 FARYDAK EQ 20MG BASE CAPSULE / ORAL RLD 2015-02-23 c2088c7a36db…2026-09-14 22:38:34 2026-08 N205353-001 FARYDAK EQ 10MG BASE CAPSULE / ORAL RLD 2015-02-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205353-002 FARYDAK EQ 15MG BASE CAPSULE / ORAL RLD 2015-02-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205353-003 FARYDAK EQ 20MG BASE CAPSULE / ORAL RLD 2015-02-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N205353-001 FARYDAK EQ 10MG BASE CAPSULE / ORAL RLD 2015-02-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205353-002 FARYDAK EQ 15MG BASE CAPSULE / ORAL RLD 2015-02-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205353-003 FARYDAK EQ 20MG BASE CAPSULE / ORAL RLD 2015-02-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205353-001 FARYDAK EQ 10MG BASE CAPSULE / ORAL RLD 2015-02-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205353-002 FARYDAK EQ 15MG BASE CAPSULE / ORAL RLD 2015-02-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205353-003 FARYDAK EQ 20MG BASE CAPSULE / ORAL RLD 2015-02-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205353-001 FARYDAK EQ 10MG BASE CAPSULE / ORAL RLD 2015-02-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205353-002 FARYDAK EQ 15MG BASE CAPSULE / ORAL RLD 2015-02-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205353-003 FARYDAK EQ 20MG BASE CAPSULE / ORAL RLD 2015-02-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205353-001 FARYDAK EQ 10MG BASE CAPSULE / ORAL RLD 2015-02-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205353-002 FARYDAK EQ 15MG BASE CAPSULE / ORAL RLD 2015-02-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205353-003 FARYDAK EQ 20MG BASE CAPSULE / ORAL RLD 2015-02-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205353-001 FARYDAK EQ 10MG BASE CAPSULE / ORAL RLD 2015-02-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205353-002 FARYDAK EQ 15MG BASE CAPSULE / ORAL RLD 2015-02-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205353-003 FARYDAK EQ 20MG BASE CAPSULE / ORAL RLD 2015-02-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205353-001 FARYDAK EQ 10MG BASE CAPSULE / ORAL RLD 2015-02-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205353-002 FARYDAK EQ 15MG BASE CAPSULE / ORAL RLD 2015-02-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205353-003 FARYDAK EQ 20MG BASE CAPSULE / ORAL RLD 2015-02-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205353-001 FARYDAK EQ 10MG BASE CAPSULE / ORAL RLD 2015-02-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205353-002 FARYDAK EQ 15MG BASE CAPSULE / ORAL RLD 2015-02-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205353-003 FARYDAK EQ 20MG BASE CAPSULE / ORAL RLD 2015-02-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205353-001 FARYDAK EQ 10MG BASE CAPSULE / ORAL RLD 2015-02-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205353-002 FARYDAK EQ 15MG BASE CAPSULE / ORAL RLD 2015-02-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205353-003 FARYDAK EQ 20MG BASE CAPSULE / ORAL RLD 2015-02-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205353-001 FARYDAK EQ 10MG BASE CAPSULE / ORAL RLD 2015-02-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205353-002 FARYDAK EQ 15MG BASE CAPSULE / ORAL RLD 2015-02-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205353-003 FARYDAK EQ 20MG BASE CAPSULE / ORAL RLD 2015-02-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205353-001 FARYDAK EQ 10MG BASE CAPSULE / ORAL RLD 2015-02-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205353-002 FARYDAK EQ 15MG BASE CAPSULE / ORAL RLD 2015-02-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205353-003 FARYDAK EQ 20MG BASE CAPSULE / ORAL RLD 2015-02-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205353-001 FARYDAK EQ 10MG BASE CAPSULE / ORAL RLD 2015-02-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205353-002 FARYDAK EQ 15MG BASE CAPSULE / ORAL RLD 2015-02-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205353-003 FARYDAK EQ 20MG BASE CAPSULE / ORAL RLD 2015-02-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205353-001 FARYDAK EQ 10MG BASE CAPSULE / ORAL RLD 2015-02-23 79d66fd596c7…
Observed Orange Book patent history# Patent history page 1 of 9 · 345 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N205353-001 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205353-001 8883842 2028-06-13 U-1669 2015-03-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205353-002 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205353-002 8883842 2028-06-13 U-1669 2015-03-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205353-003 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205353-003 8883842 2028-06-13 U-1669 2015-03-20 c2088c7a36db…2026-09-14 22:38:34 2026-08 N205353-001 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205353-001 8883842 2028-06-13 U-1669 2015-03-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205353-002 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205353-002 8883842 2028-06-13 U-1669 2015-03-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205353-003 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205353-003 8883842 2028-06-13 U-1669 2015-03-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N205353-001 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205353-001 8883842 2028-06-13 U-1669 2015-03-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205353-002 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205353-002 8883842 2028-06-13 U-1669 2015-03-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205353-003 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205353-003 8883842 2028-06-13 U-1669 2015-03-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205353-001 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205353-001 8883842 2028-06-13 U-1669 2015-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205353-002 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205353-002 8883842 2028-06-13 U-1669 2015-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205353-003 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205353-003 8883842 2028-06-13 U-1669 2015-03-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205353-001 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205353-001 8883842 2028-06-13 U-1669 2015-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205353-002 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205353-002 8883842 2028-06-13 U-1669 2015-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205353-003 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205353-003 8883842 2028-06-13 U-1669 2015-03-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205353-001 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205353-001 8883842 2028-06-13 U-1669 2015-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205353-002 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205353-002 8883842 2028-06-13 U-1669 2015-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205353-003 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205353-003 8883842 2028-06-13 U-1669 2015-03-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205353-001 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205353-001 8883842 2028-06-13 U-1669 2015-03-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205353-002 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205353-002 8883842 2028-06-13 U-1669 2015-03-20 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 72 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0078-0651-06 00078065106 6 CAPSULE in 1 BLISTER PACK (0078-0651-06) 6 capsule 2015-02-23 2022-12-31 No No Current