Gilenya

Product NDC: 0078-0607
11-digit product format: 000780607
Labeler code: 0078
Product ID: 0078-0607_7b0c88c7-0bb4-44a4-9855-3156bfc63a66
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fingolimod hcl
Dosage form: CAPSULE
Route: ORAL
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA022527
Marketing category: NDA
Marketing start: 2010-09-21
Substance: FINGOLIMOD HYDROCHLORIDE
Active strength: .5 mg/1
Pharmacologic classes: Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0078-0607	0078-0607-51	D	Discontinued by firm		2026-08-17
excluded package	package	0078-0607	0078-0607-89	D	Discontinued by firm		2026-08-17

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, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	0078-0607-51	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0078-0607-89	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	0078-0607-89	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0078-0607-51	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	0078-0607-51	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0078-0607-89	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	0078-0607-51	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0078-0607-89	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	0078-0607-51	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0078-0607-89	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	0078-0607-51	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0078-0607-89	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	0078-0607-51	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0078-0607-89	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	0078-0607-51	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	0078-0607-89	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	0078-0607-51	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	0078-0607-89	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	0078-0607-51	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	0078-0607-89	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	0078-0607-51	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	0078-0607-89	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	0078-0607-51	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	0078-0607-89	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022527-001	GILENYA	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21
N022527-002	GILENYA	FINGOLIMOD HYDROCHLORIDE	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N022527-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022527-001	10543179	2027-12-25	U-2719		2020-01-28
N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19
N022527-002	9592208*PED	2032-09-30		Pediatric extension

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 3 · 84 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
2026-08-18 06:07:40	2026-07	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL	AB	RLD	2018-05-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL	AB	RLD	2018-05-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL	AB	RLD	2018-05-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL		RLD, RS	2010-09-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL	AB	RLD	2018-05-11	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N022527-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022527-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022527-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022527-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022527-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022527-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022527-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022527-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022527-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022527-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022527-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022527-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022527-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022527-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022527-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022527-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022527-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022527-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022527-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022527-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022527-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022527-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022527-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022527-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022527-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022527-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022527-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022527-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022527-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022527-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022527-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022527-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022527-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022527-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022527-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022527-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022527-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022527-001	AB	1	`3a93d1ddd44b…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 287 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	N022527-001	10543179	2027-12-25	U-2719		2020-01-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022527-002	9592208*PED	2032-09-30		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022527-001	10543179	2027-12-25	U-2719		2020-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022527-002	9592208*PED	2032-09-30		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022527-001	10543179	2027-12-25	U-2719		2020-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022527-002	9592208*PED	2032-09-30		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022527-001	10543179	2027-12-25	U-2719		2020-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022527-002	9592208*PED	2032-09-30		Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022527-001	10543179	2027-12-25	U-2719		2020-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022527-002	9592208*PED	2032-09-30		Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-001	8324283	2026-03-29		Drug product	2013-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-001	8324283*PED	2026-09-29		Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-001	9187405	2027-06-25	U-2613		2015-12-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-001	10543179	2027-12-25	U-2719		2020-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-001	9187405*PED	2027-12-25		Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-002	9592208*PED	2032-09-30		Pediatric extension		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-001	8324283	2026-03-29		Drug product	2013-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-001	8324283*PED	2026-09-29		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-001	9187405	2027-06-25	U-2613		2015-12-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-001	10543179	2027-12-25	U-2719		2020-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-001	9187405*PED	2027-12-25		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-002	9592208*PED	2032-09-30		Pediatric extension		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022527-001	8324283	2026-03-29		Drug product	2013-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022527-001	8324283*PED	2026-09-29		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022527-001	9187405	2027-06-25	U-2613		2015-12-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022527-001	10543179	2027-12-25	U-2719		2020-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022527-001	9187405*PED	2027-12-25		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022527-002	9592208*PED	2032-09-30		Pediatric extension		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022527-001	8324283	2026-03-29		Drug product	2013-01-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022527-001	8324283*PED	2026-09-29		Pediatric extension		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022527-001	9187405	2027-06-25	U-2613		2015-12-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022527-001	10543179	2027-12-25	U-2719		2020-01-28	`5bbf6a4d5a75…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022527-001	NPP	2021-05-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022527-001	PED	2021-11-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022527-002	NS	2021-05-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022527-002	PED	2021-11-11	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N022527-001	NPP	2021-05-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022527-001	PED	2021-11-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022527-002	NS	2021-05-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022527-002	PED	2021-11-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022527-001	NPP	2021-05-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022527-001	PED	2021-11-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022527-002	NS	2021-05-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022527-002	PED	2021-11-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022527-001	NPP	2021-05-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022527-001	PED	2021-11-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022527-002	NS	2021-05-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022527-002	PED	2021-11-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022527-001	NPP	2021-05-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022527-001	PED	2021-11-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022527-002	NS	2021-05-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022527-002	PED	2021-11-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022527-001	NPP	2021-05-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022527-001	PED	2021-11-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022527-002	NS	2021-05-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022527-002	PED	2021-11-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022527-001	NPP	2021-05-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022527-001	PED	2021-11-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022527-002	NS	2021-05-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022527-002	PED	2021-11-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022527-001	NPP	2021-05-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022527-001	PED	2021-11-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022527-002	NS	2021-05-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022527-002	PED	2021-11-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022527-001	NPP	2021-05-11	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022527-001	PED	2021-11-11	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022527-002	NS	2021-05-11	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022527-002	PED	2021-11-11	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Gilenya
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FINGOLIMOD HYDROCHLORIDE	.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G926EC510T	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1012895	Internal RxNorm lookup
1012899	Internal RxNorm lookup
2045491	Internal RxNorm lookup
2045493	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
cc9e1c8c-0e2b-44e2-878b-27057f786be9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
665f4aef-df96-42b3-97d1-5971737de3dc	Product name	9	20250121
6b6bc7ea-a5a8-4e5e-b81d-4b6b4cbe6f45	Product name	1	20230919

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0078-0607-15	Gilenya	30 in 1 BOTTLE	CAPSULE	30	39
0078-0607-51	Gilenya	28 in 1 CARTON	CAPSULE	28	39
0078-0607-89	Gilenya	7 in 1 CARTON	CAPSULE	7	39

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0607-15	EA - Each	0078-0607	34e73d40-24cb-4244-888d-e6089add02f1	1	2015-02-02
0078-0607-51	EA - Each	0078-0607	370f1dce-3eb2-497b-971a-6e448e815d4f	1	2012-07-24
0078-0607-89	EA - Each	0078-0607	9854909f-eb50-4eec-a924-a700e920128e	1	2015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FINGOLIMOD HYDROCHLORIDE	ACTIVE INGREDIENT	G926EC510T	GILENYA (FINGOLIMOD HCL) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	18
FINGOLIMOD	ACTIVE MOIETY	3QN8BYN5QF	GILENYA (FINGOLIMOD HCL) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	18
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GILENYA (FINGOLIMOD HCL) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	18
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GILENYA (FINGOLIMOD HCL) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	18
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GILENYA (FINGOLIMOD HCL) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	18
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	GILENYA (FINGOLIMOD HCL) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	18
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GILENYA (FINGOLIMOD HCL) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0078-0607	GILENYA (FINGOLIMOD HCL) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	38	Current NDC, Legacy NDC, 3 package rows	20250503_cc9e1c8c-0e2b-44e2-878b-27057f786be9.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gilenya	FINGOLIMOD HCL	Novartis Pharmaceuticals Corporation	cc9e1c8c-0e2b-44e2-878b-27057f786be9	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022527 application number: NDA022527 ndc (product): 0078-0607

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G926EC510T	FINGOLIMOD HYDROCHLORIDE	162359-56-0	FINGOLIMOD HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2045491	fingolimod 0.25 MG Oral Capsule	PSN	cc9e1c8c-0e2b-44e2-878b-27057f786be9	39
1012895	fingolimod 0.5 MG Oral Capsule	PSN	cc9e1c8c-0e2b-44e2-878b-27057f786be9	39
2045493	Gilenya 0.25 MG Oral Capsule	PSN	cc9e1c8c-0e2b-44e2-878b-27057f786be9	39
1012899	Gilenya 0.5 MG Oral Capsule	PSN	cc9e1c8c-0e2b-44e2-878b-27057f786be9	39
2045493	fingolimod 0.25 MG Oral Capsule [Gilenya]	SBD	cc9e1c8c-0e2b-44e2-878b-27057f786be9	39
1012899	fingolimod 0.5 MG Oral Capsule [Gilenya]	SBD	cc9e1c8c-0e2b-44e2-878b-27057f786be9	39
2045491	fingolimod 0.25 MG Oral Capsule	SCD	cc9e1c8c-0e2b-44e2-878b-27057f786be9	39
1012895	fingolimod 0.5 MG Oral Capsule	SCD	cc9e1c8c-0e2b-44e2-878b-27057f786be9	39
2045491	fingolimod 0.25 MG (as fingolimod HCl 0.28 MG) Oral Capsule	SY	cc9e1c8c-0e2b-44e2-878b-27057f786be9	39
1012895	fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule	SY	cc9e1c8c-0e2b-44e2-878b-27057f786be9	39
1012895	fingolimod 500 MCG Oral Capsule	SY	cc9e1c8c-0e2b-44e2-878b-27057f786be9	39
2045493	Gilenya 0.25 MG (as fingolimod HCl 0.28 MG) Oral Capsule	SY	cc9e1c8c-0e2b-44e2-878b-27057f786be9	39
2045493	Gilenya 0.25 MG Oral Capsule	SY	cc9e1c8c-0e2b-44e2-878b-27057f786be9	39
1012899	Gilenya 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule	SY	cc9e1c8c-0e2b-44e2-878b-27057f786be9	39
1012899	Gilenya 0.5 MG Oral Capsule	SY	cc9e1c8c-0e2b-44e2-878b-27057f786be9	39

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0607-15	00078060715	30 CAPSULE in 1 BOTTLE (0078-0607-15)	30 capsule	2010-09-21	0000-00-00	No	No	Current
0078-0607-51	00078060751	28 in 1 CARTON						Historical
0078-0607-89	00078060789	7 CAPSULE in 1 CARTON (0078-0607-89)	7 capsule	2010-09-21	0000-00-00	No	No	Current