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Active ingredient

Zolmitriptan

46 finished FDA listings contain Zolmitriptan as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
ZOLMITRIPTAN
Dosage forms
Spray, Spray, Metered, Tablet, Tablet, Film Coated, Tablet, Orally Disintegrating
Routes
Nasal, Oral
Manufacturers / labelers
21
Strengths listed
2.5 mg/1 · 5 mg/1
Brand names in FDA listings
Zolmiptriptan, Zolmitriptan Od, Zomig

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 135775

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 021450AMNEAL2003-09-302
ANDA 202560GLENMARK PHARMS LTD2013-05-142
ANDA 201779GLENMARK PHARMS LTD2013-05-144
ANDA 202890ZYDUS PHARMS USA INC2013-05-154
ANDA 204284INVAGEN PHARMS2014-04-092
ANDA 202956JUBILANT GENERICS2015-09-174
ANDA 204232ALEMBIC2015-09-304
ANDA 207021AUROBINDO PHARMA2016-05-114
ANDA 204041AJANTA PHARMA LTD2016-05-206
ANDA 205074ALEMBIC2016-12-014
ANDA 207867PLD ACQUISITIONS LLC2017-02-276
ANDA 212469PADAGIS ISRAEL2021-09-304

Official labeling on DailyMed

Showing the 12 most recent of 26 labels.

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