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Active ingredient

Dapagliflozin

50 finished FDA listings contain Dapagliflozin as their only active ingredient; 34 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
DAPAGLIFLOZIN, DAPAGLIFLOZIN 2,3-BUTANEDIOL MONOHYDRATE, DAPAGLIFLOZIN PROPANEDIOL
Dosage forms
Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
24
Strengths listed
10 mg/1 · 5 mg/1
Brand names in FDA listings
Farxiga

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 1488564

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 202293ASTRAZENECA AB2014-01-0810
ANDA 211156INVENTIA2026-04-064
ANDA 211468AUROBINDO PHARMA2026-04-064
ANDA 211582ZYDUS PHARMS2026-04-064
ANDA 211478MSN2026-04-064
ANDA 211560ALEMBIC2026-04-064
ANDA 211541TEVA PHARMS USA2026-04-063
ANDA 211506MACLEODS PHARMS2026-04-063
ANDA 211531LUPIN2026-04-062
ANDA 211535CIPLA2026-04-062
ANDA 211545ALKEM LABS LTD2026-04-062
ANDA 211470BIOCON PHARMA2026-04-062
ANDA 211482AJANTA PHARMA LTD2026-04-062
ANDA 211312SANDOZ2026-04-062
ANDA 211523AIZANT2026-04-062

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.