FDA.reportPublic FDA data

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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0078-06070078-0607-51DDiscontinued by firm2026-07-31
excluded packagepackage0078-06070078-0607-89DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022527-001GILENYAFINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALABRLD, RS2010-09-21
N022527-002GILENYAFINGOLIMOD HYDROCHLORIDEEQ 0.25MG BASECAPSULE / ORALRLD2018-05-11

Therapeutic equivalence codes#

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

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

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022527-001105431792027-12-25U-27192020-01-28
N022527-00295922082032-03-30U-2315Drug product2018-06-19
N022527-0029592208*PED2032-09-30Pediatric 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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N022527-001GILENYAEQ 0.5MG BASECAPSULE / ORALABRLD, RS2010-09-21a50c72e98297…
2026-08-01 22:54:322026-06N022527-002GILENYAEQ 0.25MG BASECAPSULE / ORALRLD2018-05-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N022527-001AB1a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N022527-001105431792027-12-25U-27192020-01-28a50c72e98297…
2026-08-01 22:54:322026-06N022527-00295922082032-03-30U-2315Drug product2018-06-19a50c72e98297…
2026-08-01 22:54:322026-06N022527-0029592208*PED2032-09-30Pediatric extensiona50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GilenyaFINGOLIMOD HCLNovartis Pharmaceuticals Corporationcc9e1c8c-0e2b-44e2-878b-27057f786be92026-07-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 022527
application number: NDA022527
ndc (product): 0078-0607

Additional Listing Data#

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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G926EC510TInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cc9e1c8c-0e2b-44e2-878b-27057f786be9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
665f4aef-df96-42b3-97d1-5971737de3dcProduct name920250121
6b6bc7ea-a5a8-4e5e-b81d-4b6b4cbe6f45Product name120230919

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0607-15Gilenya30 in 1 BOTTLECAPSULE3039
0078-0607-51Gilenya28 in 1 CARTONCAPSULE2839
0078-0607-89Gilenya7 in 1 CARTONCAPSULE739

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0607-15EA - Each0078-060734e73d40-24cb-4244-888d-e6089add02f112015-02-02
0078-0607-51EA - Each0078-0607370f1dce-3eb2-497b-971a-6e448e815d4f12012-07-24
0078-0607-89EA - Each0078-06079854909f-eb50-4eec-a924-a700e920128e12015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FINGOLIMOD HYDROCHLORIDEACTIVE INGREDIENTG926EC510TGILENYA (FINGOLIMOD HCL) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]18
FINGOLIMODACTIVE MOIETY3QN8BYN5QFGILENYA (FINGOLIMOD HCL) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]18
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGILENYA (FINGOLIMOD HCL) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]18
GELATININACTIVE INGREDIENT2G86QN327LGILENYA (FINGOLIMOD HCL) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]18
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GILENYA (FINGOLIMOD HCL) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]18
MANNITOLINACTIVE INGREDIENT3OWL53L36AGILENYA (FINGOLIMOD HCL) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]18
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGILENYA (FINGOLIMOD HCL) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0607GILENYA (FINGOLIMOD HCL) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]38Current NDC, Legacy NDC, 3 package rows20250503_cc9e1c8c-0e2b-44e2-878b-27057f786be9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2045491fingolimod 0.25 MG Oral CapsulePSNcc9e1c8c-0e2b-44e2-878b-27057f786be939
1012895fingolimod 0.5 MG Oral CapsulePSNcc9e1c8c-0e2b-44e2-878b-27057f786be939
2045493Gilenya 0.25 MG Oral CapsulePSNcc9e1c8c-0e2b-44e2-878b-27057f786be939
1012899Gilenya 0.5 MG Oral CapsulePSNcc9e1c8c-0e2b-44e2-878b-27057f786be939
2045493fingolimod 0.25 MG Oral Capsule [Gilenya]SBDcc9e1c8c-0e2b-44e2-878b-27057f786be939
1012899fingolimod 0.5 MG Oral Capsule [Gilenya]SBDcc9e1c8c-0e2b-44e2-878b-27057f786be939
2045491fingolimod 0.25 MG Oral CapsuleSCDcc9e1c8c-0e2b-44e2-878b-27057f786be939
1012895fingolimod 0.5 MG Oral CapsuleSCDcc9e1c8c-0e2b-44e2-878b-27057f786be939
2045491fingolimod 0.25 MG (as fingolimod HCl 0.28 MG) Oral CapsuleSYcc9e1c8c-0e2b-44e2-878b-27057f786be939
1012895fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral CapsuleSYcc9e1c8c-0e2b-44e2-878b-27057f786be939
1012895fingolimod 500 MCG Oral CapsuleSYcc9e1c8c-0e2b-44e2-878b-27057f786be939
2045493Gilenya 0.25 MG (as fingolimod HCl 0.28 MG) Oral CapsuleSYcc9e1c8c-0e2b-44e2-878b-27057f786be939
2045493Gilenya 0.25 MG Oral CapsuleSYcc9e1c8c-0e2b-44e2-878b-27057f786be939
1012899Gilenya 0.5 MG (as fingolimod HCl 0.56 MG) Oral CapsuleSYcc9e1c8c-0e2b-44e2-878b-27057f786be939
1012899Gilenya 0.5 MG Oral CapsuleSYcc9e1c8c-0e2b-44e2-878b-27057f786be939

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0607-150007806071530 CAPSULE in 1 BOTTLE (0078-0607-15) 30 capsule2010-09-210000-00-00NoNoCurrent
0078-0607-510007806075128 in 1 CARTONHistorical
0078-0607-89000780607897 CAPSULE in 1 CARTON (0078-0607-89) 7 capsule2010-09-210000-00-00NoNoCurrent