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Active ingredient

Fingolimod

25 finished FDA listings contain Fingolimod as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
FINGOLIMOD, FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD LAURYL SULFATE
Dosage forms
Capsule, Tablet, Orally Disintegrating
Routes
Oral
Manufacturers / labelers
23
Strengths listed
.25 mg/1 · .5 mg/1
Brand names in FDA listings
Fingolimod, Gilenya, Tascenso Odt

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 1012892

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 022527NOVARTIS2010-09-212
ANDA 208014SUN PHARM2019-12-041
ANDA 207979BIOCON LTD2019-12-042
ANDA 207933HETERO LABS LTD V2020-05-182
ANDA 207985GLENMARK PHARMS LTD2020-06-181
ANDA 208008TEVA PHARMS USA2020-07-022
ANDA 207994ZYDUS PHARMS2020-10-142
ANDA 207991ACCORD HLTHCARE2020-10-281
ANDA 207993APOTEX2020-12-182
ANDA 208004ALKEM LABS LTD2020-12-302
ANDA 208000DR REDDYS2021-03-051
ANDA 207939HEC PHARM CO LTD2021-11-101
NDA 214962CYCLE2021-12-232
ANDA 208003PRINSTON INC2022-09-071
ANDA 207983AUROBINDO PHARMA LTD2024-02-281
ANDA 207974ALEMBIC2026-04-242

Official labeling on DailyMed

Showing the 12 most recent of 22 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.