FDA.reportPublic FDA data

fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule

RxCUI
1012895
RxNorm name
fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule
Display name
fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule
Full name
fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:21

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

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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 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FingolimodFINGOLIMODXLCare Pharmaceuticals Inc.c5402dd1-c496-405d-9cae-07ccf184339c2024-06-20Warnings, Adverse reactionsExact identifier
rxcui: 1012895

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 20 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
cc9e1c8c-0e2b-44e2-878b-27057f786be9fingolimod 0.5 MG Oral Capsule [PSN] · fingolimod 0.5 MG Oral Capsule [SCD] · fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule [SY] · fingolimod 500 MCG Oral Capsule [SY]439These highlights do not include all the information needed to use GILENYA ® safely and effectively. See full prescribing information for GILENYA. GILENYA (fingolimod) capsules, for oral use Initial U.S. Approval: 201020250822
550a5fa3-94a4-0b55-9cb5-c0178acfe319fingolimod 0.5 MG Oral Capsule [PSN] · fingolimod 0.5 MG Oral Capsule [SCD] · fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule [SY] · fingolimod 500 MCG Oral Capsule [SY]422These highlights do not include all the information needed to use FINGOLIMOD CAPSULES safely and effectively. See full prescribing information for FINGOLIMOD CAPSULES. FINGOLIMOD capsules, for oral use Initial U.S. Approval: 201020251126
0f638feb-6986-41e4-8f9c-2e6b84a5bb44fingolimod 0.5 MG Oral Capsule [PSN] · fingolimod 0.5 MG Oral Capsule [SCD] · fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule [SY] · fingolimod 500 MCG Oral Capsule [SY]419These highlights do not include all the information needed to use FINGOLIMOD CAPSULES safely and effectively. See full prescribing information for FINGOLIMOD CAPSULES. FINGOLIMOD capsules, for oral use Initial U.S. Approval: 201020260327
99e7daf4-ea90-5e47-e053-2a95a90ac1b7fingolimod 0.5 MG Oral Capsule [PSN] · fingolimod 0.5 MG Oral Capsule [SCD] · fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule [SY] · fingolimod 500 MCG Oral Capsule [SY]417These highlights do not include all the information needed to use FINGOLIMOD CAPSULES safely and effectively. See full prescribing information for FINGOLIMOD CAPSULES. FINGOLIMOD capsules, for oral use Initial U.S. Approval: 201020241104
56badc2a-6747-9284-300e-bf072eb072edfingolimod 0.5 MG Oral Capsule [PSN] · fingolimod 0.5 MG Oral Capsule [SCD] · fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule [SY] · fingolimod 500 MCG Oral Capsule [SY]413These highlights do not include all the information needed to use FINGOLIMOD CAPSULES safely and effectively. See full prescribing information for FINGOLIMOD CAPSULES . FINGOLIMOD capsules, for oral use Initial U.S. Approval: 201020251022
54bf842e-9772-424d-87b2-61863b6f4b19fingolimod 0.5 MG Oral Capsule [PSN] · fingolimod 0.5 MG Oral Capsule [SCD] · fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule [SY] · fingolimod 500 MCG Oral Capsule [SY]410These highlights do not include all the information needed to use FINGOLIMOD CAPSULES safely and effectively. See full prescribing information for FINGOLIMOD CAPSULES. FINGOLIMOD capsules, for oral use Initial U.S. Approval: 201020260427
a545c6fc-7006-52c2-f476-34e9801ac04ffingolimod 0.5 MG Oral Capsule [PSN] · fingolimod 0.5 MG Oral Capsule [SCD] · fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule [SY] · fingolimod 500 MCG Oral Capsule [SY]48These highlights do not include all the information needed to use FINGOLIMOD CAPSULES safely and effectively. See full prescribing information for FINGOLIMOD CAPSULES. FINGOLIMOD capsules, for oral use Initial U.S. Approval: 201020250911
b228dac8-b07d-424d-b23b-a03573517c54fingolimod 0.5 MG Oral Capsule [PSN] · fingolimod 0.5 MG Oral Capsule [SCD] · fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule [SY] · fingolimod 500 MCG Oral Capsule [SY]48These highlights do not include all the information needed to use FINGOLIMOD CAPSULES safely and effectively. See full prescribing information for FINGOLIMOD CAPSULES. FINGOLIMOD capsules, for oral use Initial U.S. Approval: 201020250905
e738dbd9-f4cc-49a0-98ce-73dd0c3ff3b3fingolimod 0.5 MG Oral Capsule [PSN] · fingolimod 0.5 MG Oral Capsule [SCD] · fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule [SY] · fingolimod 500 MCG Oral Capsule [SY]48These highlights do not include all the information needed to use FINGOLIMOD CAPSULES safely and effectively. See full prescribing information for FINGOLIMOD CAPSULES. FINGOLIMOD capsules, for oral use Initial U.S. Approval: 201020250902
d9aa1078-fd72-47ef-84b2-2e1ad17b12a2fingolimod 0.5 MG Oral Capsule [PSN] · fingolimod 0.5 MG Oral Capsule [SCD] · fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule [SY] · fingolimod 500 MCG Oral Capsule [SY]47These highlights do not include all the information needed to use FINGOLIMOD CAPSULES safely and effectively. See full prescribing information for FINGOLIMOD CAPSULES. FINGOLIMOD capsules, for oral use Initial U.S. Approval: 201020251101
8fe14efd-8f61-40db-9069-bb17daf3261afingolimod 0.5 MG Oral Capsule [PSN] · fingolimod 0.5 MG Oral Capsule [SCD] · fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule [SY] · fingolimod 500 MCG Oral Capsule [SY]45These highlights do not include all the information needed to use FINGOLIMOD CAPSULES safely and effectively. See full prescribing information for FINGOLIMOD CAPSULES. FINGOLIMOD capsules, for oral use Initial U.S. Approval: 201020260131
d6301307-55c6-4b91-a505-ff93c865f859fingolimod 0.5 MG Oral Capsule [PSN] · fingolimod 0.5 MG Oral Capsule [SCD] · fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule [SY] · fingolimod 500 MCG Oral Capsule [SY]45These highlights do not include all the information needed to use FINGOLIMOD CAPSULES safely and effectively. See full prescribing information for FINGOLIMOD CAPSULES. FINGOLIMOD capsules, for oral use Initial U.S. Approval: 201020260101
c3199508-3d6a-4e44-96f0-bbde9969edcbfingolimod 0.5 MG Oral Capsule [PSN] · fingolimod 0.5 MG Oral Capsule [SCD] · fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule [SY] · fingolimod 500 MCG Oral Capsule [SY]45These highlights do not include all the information needed to use FINGOLIMOD CAPSULES safely and effectively. See full prescribing information for FINGOLIMOD CAPSULES. FINGOLIMOD capsules, for oral use Initial U.S. Approval: 201020251218
65e59a51-c9c2-47b4-84fc-e0f8879eb26cfingolimod 0.5 MG Oral Capsule [PSN] · fingolimod 0.5 MG Oral Capsule [SCD] · fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule [SY] · fingolimod 500 MCG Oral Capsule [SY]45These highlights do not include all the information needed to use FINGOLIMOD CAPSULES safely and effectively. See full prescribing information for FINGOLIMOD CAPSULES. FINGOLIMOD capsules, for oral use Initial U.S. Approval: 201020251016
5a0319b4-4bc6-4564-9687-9cfd5c1b23a8fingolimod 0.5 MG Oral Capsule [PSN] · fingolimod 0.5 MG Oral Capsule [SCD] · fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule [SY] · fingolimod 500 MCG Oral Capsule [SY]45Fingolimod Capsules20241130
5434bd4a-2610-0e17-4f14-513ff1cbb822fingolimod 0.5 MG Oral Capsule [PSN] · fingolimod 0.5 MG Oral Capsule [SCD] · fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule [SY] · fingolimod 500 MCG Oral Capsule [SY]43These highlights do not include all the information needed to use FINGOLIMOD CAPSULES safely and effectively. See full prescribing information for FINGOLIMOD CAPSULES. FINGOLIMOD capsules, for oral use Initial U.S. Approval: 201020251215
1171df44-48b4-6ef2-e063-6294a90aa121fingolimod 0.5 MG Oral Capsule [PSN] · fingolimod 0.5 MG Oral Capsule [SCD] · fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule [SY] · fingolimod 500 MCG Oral Capsule [SY]42FINGOLIMOD These highlights do not include all the information needed to use FINGOLIMOD CAPSULES safely and effectively. See full prescribing information for FINGOLIMOD CAPSULES. Initial U.S. Approval: 201020260113
6c0faf2b-21fb-4830-bb78-5f2dbceb2c82fingolimod 0.5 MG Oral Capsule [PSN] · fingolimod 0.5 MG Oral Capsule [SCD] · fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule [SY] · fingolimod 500 MCG Oral Capsule [SY]42These highlights do not include all the information needed to use FINGOLIMOD CAPSULES safely and effectively. See full prescribing information for FINGOLIMOD CAPSULES . FINGOLIMOD capsules, for oral use Initial U.S. Approval: 201020240731
c5402dd1-c496-405d-9cae-07ccf184339cfingolimod 0.5 MG Oral Capsule [PSN] · fingolimod 0.5 MG Oral Capsule [SCD] · fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule [SY] · fingolimod 500 MCG Oral Capsule [SY]42These highlights do not include all the information needed to use FINGOLIMOD CAPSULES safely and effectively. See full prescribing information for FINGOLIMOD CAPSULES. FINGOLIMOD capsules, for oral use Initial U.S. Approval: 201020240620
d0538769-3cec-4cf2-97e5-41e79599c181fingolimod 0.5 MG Oral Capsule [PSN] · fingolimod 0.5 MG Oral Capsule [SCD] · fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule [SY] · fingolimod 500 MCG Oral Capsule [SY]41These highlights do not include all the information needed to use FINGOLIMOD CAPSULES safely and effectively. See full prescribing information for FINGOLIMOD CAPSULES. FINGOLIMOD capsules, for oral use Initial U.S. Approval: 201020260430