FARYDAK

Product NDC: 73116-101
Requested package NDC: 73116-101-06
11-digit product format: 731160101
Labeler code: 73116
Product ID: 73116-101_8368e056-cfe2-4f4b-8033-dd7e14689eaf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: panobinostat
Dosage form: CAPSULE
Route: ORAL
Labeler: Secura Bio, Inc.
Application: NDA205353
Marketing category: NDA
Marketing start: 2015-02-23
Marketing end: 0000-00-00
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: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	73116-101	73116-101-06	I	Inactivated by FDA		2026-10-16

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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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	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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205353-001	ODE-89	2022-02-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205353-002	ODE-89	2022-02-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205353-003	ODE-89	2022-02-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205353-001	ODE-89	2022-02-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N205353-002	ODE-89	2022-02-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N205353-003	ODE-89	2022-02-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205353-001	ODE-89	2022-02-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N205353-002	ODE-89	2022-02-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N205353-003	ODE-89	2022-02-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205353-001	NCE	2020-02-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205353-001	ODE-89	2022-02-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205353-002	NCE	2020-02-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205353-002	ODE-89	2022-02-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205353-003	NCE	2020-02-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205353-003	ODE-89	2022-02-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205353-001	ODE-89	2022-02-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N205353-002	ODE-89	2022-02-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N205353-003	ODE-89	2022-02-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205353-001	ODE-89	2022-02-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N205353-002	ODE-89	2022-02-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N205353-003	ODE-89	2022-02-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205353-001	ODE-89	2022-02-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205353-002	ODE-89	2022-02-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205353-003	ODE-89	2022-02-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205353-001	ODE-89	2022-02-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N205353-002	ODE-89	2022-02-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N205353-003	ODE-89	2022-02-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205353-001	NCE	2020-02-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205353-001	ODE-89	2022-02-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205353-002	NCE	2020-02-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205353-002	ODE-89	2022-02-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205353-003	NCE	2020-02-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205353-003	ODE-89	2022-02-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205353-001	NCE	2020-02-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205353-001	ODE-89	2022-02-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205353-002	NCE	2020-02-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205353-002	ODE-89	2022-02-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205353-003	NCE	2020-02-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205353-003	ODE-89	2022-02-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205353-001	NCE	2020-02-23	`3f01610625f2…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
7a7fbcda-1e19-4011-83b5-030a5c13a2d0	Product name	1	20150319
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
73116-101-06	2023-01-30	C162847	48780-1	c7ccaba7-2835-fd44-e053-dadaa90aa01b	These highlights do not include all the information needed to use FARYDAK safely and effectively. See full prescribing information for FARYDAK. FARYDAK ® (panobinostat) capsules, for oral use Initial U.S. Approval: 2015
73116-101-06	2021-07-28	C162847	48780-1	c7ccaba7-2835-fd44-e053-dadaa90aa01b	These highlights do not include all the information needed to use FARYDAK safely and effectively. See full prescribing information for FARYDAK. FARYDAK ® (panobinostat) capsules, for oral use Initial U.S. Approval: 2015
73116-101-06	2021-07-23	C162847	48780-1	c7ccaba7-2835-fd44-e053-dadaa90aa01b	These highlights do not include all the information needed to use FARYDAK safely and effectively. See full prescribing information for FARYDAK. FARYDAK ® (panobinostat) capsules, for oral use Initial U.S. Approval: 2015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73116-101-06	FARYDAK	1 in 1 CARTON	CAPSULE	1		3
73116-101-06	FARYDAK	6 in 1 BLISTER PACK	CAPSULE	6		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
73116-101-06	EA - Each	73116-101	6ee2ffe1-9a65-40a8-a94c-864f3b9ccf33	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73116-101	FARYDAK (PANOBINOSTAT) CAPSULE [SECURA BIO, INC.]	3	Legacy NDC, 2 package rows	20210729_1b97bd3a-1040-4511-b0e6-4758e8083ae5.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HN0T99OO4V	PANOBINOSTAT LACTATE	960055-56-5	PANOBINOSTAT LACTATE
9647FM7Y3Z	PANOBINOSTAT	404950-80-7	panobinostat

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1603361	FARYDAK 10 MG Oral Capsule	PSN	1b97bd3a-1040-4511-b0e6-4758e8083ae5	3
1603365	FARYDAK 15 MG Oral Capsule	PSN	1b97bd3a-1040-4511-b0e6-4758e8083ae5	3
1603369	FARYDAK 20 MG Oral Capsule	PSN	1b97bd3a-1040-4511-b0e6-4758e8083ae5	3
1603355	panobinostat 10 MG Oral Capsule	PSN	1b97bd3a-1040-4511-b0e6-4758e8083ae5	3
1603363	panobinostat 15 MG Oral Capsule	PSN	1b97bd3a-1040-4511-b0e6-4758e8083ae5	3
1603367	panobinostat 20 MG Oral Capsule	PSN	1b97bd3a-1040-4511-b0e6-4758e8083ae5	3
1603361	panobinostat 10 MG Oral Capsule [Farydak]	SBD	1b97bd3a-1040-4511-b0e6-4758e8083ae5	3
1603365	panobinostat 15 MG Oral Capsule [Farydak]	SBD	1b97bd3a-1040-4511-b0e6-4758e8083ae5	3
1603369	panobinostat 20 MG Oral Capsule [Farydak]	SBD	1b97bd3a-1040-4511-b0e6-4758e8083ae5	3
1603355	panobinostat 10 MG Oral Capsule	SCD	1b97bd3a-1040-4511-b0e6-4758e8083ae5	3
1603363	panobinostat 15 MG Oral Capsule	SCD	1b97bd3a-1040-4511-b0e6-4758e8083ae5	3
1603367	panobinostat 20 MG Oral Capsule	SCD	1b97bd3a-1040-4511-b0e6-4758e8083ae5	3
1603361	Farydak 10 MG Oral Capsule	SY	1b97bd3a-1040-4511-b0e6-4758e8083ae5	3
1603365	Farydak 15 MG Oral Capsule	SY	1b97bd3a-1040-4511-b0e6-4758e8083ae5	3
1603369	Farydak 20 MG Oral Capsule	SY	1b97bd3a-1040-4511-b0e6-4758e8083ae5	3
1603355	panobinostat 10 MG (as panobinostat lactate 12.58 MG) Oral Capsule	SY	1b97bd3a-1040-4511-b0e6-4758e8083ae5	3
1603363	panobinostat 15 MG (as panobinostat lactate 18.86 MG) Oral Capsule	SY	1b97bd3a-1040-4511-b0e6-4758e8083ae5	3
1603367	panobinostat 20 MG (as panobinostat lactate 25.15 MG) Oral Capsule	SY	1b97bd3a-1040-4511-b0e6-4758e8083ae5	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
73116-101-06	73116010106	1 BLISTER PACK in 1 CARTON (73116-101-06) > 6 CAPSULE in 1 BLISTER PACK	1 blister pack	2015-02-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FARYDAK	Secura Bio, Inc. \| Siegfried Barbera, S.L. \| Novartis Pharma Schweizerhalle AG	2021-07-27	HUMAN PRESCRIPTION DRUG LABEL	3