Home NDC 0078-0965 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.
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# 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.
DailyMed Product Concepts# 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 Socrata Ingredients# 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
DailyMed RxNorm Mappings# 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