Gilenya

Product NDC: 0078-0965
11-digit product format: 000780965
Labeler code: 0078
Product ID: 0078-0965_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: .25 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 82 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
2026-02-19 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…`
2021-12-28 21:50 UTC	2021-12	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL	AB	RLD	2018-05-11	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-10-28 04:53 UTC	2022-10	N022527-001	AB	1	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 284 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
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…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022527-001	9187405*PED	2027-12-25		Pediatric extension		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022527-002	9592208*PED	2032-09-30		Pediatric extension		`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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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): 0078-0965

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FINGOLIMOD HYDROCHLORIDE	.25 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	Strength	SPL version
0078-0965-89	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
0078-0965-89	EA - Each	0078-0965	3c25c2c2-c2cb-4a48-8b65-0b7deebe8121	1	2018-06-11

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
0078-0965	GILENYA (FINGOLIMOD HCL) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	38	Current NDC, Legacy NDC, 1 package rows	20250503_cc9e1c8c-0e2b-44e2-878b-27057f786be9.zip

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
0078-0965-89	00078096589	7 CAPSULE in 1 CARTON (0078-0965-89)	7 capsule	2018-05-11	0000-00-00	No	No	Current