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.
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 2026-08-01 22:54:32 2026-06 N022527-001 GILENYA EQ 0.5MG BASE CAPSULE / ORAL AB RLD, RS 2010-09-21 a50c72e98297…2026-08-01 22:54:32 2026-06 N022527-002 GILENYA EQ 0.25MG BASE CAPSULE / ORAL RLD 2018-05-11 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N022527-001 AB 1 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N022527-001 10543179 2027-12-25 U-2719 2020-01-28 a50c72e98297…2026-08-01 22:54:32 2026-06 N022527-002 9592208 2032-03-30 U-2315 Drug product 2018-06-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N022527-002 9592208*PED 2032-09-30 Pediatric extension a50c72e98297…
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