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Active ingredient

Sitagliptin

36 finished FDA listings contain Sitagliptin as their only active ingredient; 39 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
SITAGLIPTIN, SITAGLIPTIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE
Dosage forms
Solution, Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
10
Strengths listed
100 mg/1 · 25 mg/1 · 25 mg/ml · 50 mg/1
Brand names in FDA listings
Brynovin, Januvia, Zituvio

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 593411

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 021995MSD2006-10-1611
NDA 211566ZYDUS LIFESCIENCES2023-10-1812
NDA 219122AZURITY2025-01-161
ANDA 202327WATSON LABS INC2025-12-293
ANDA 202387SANDOZ2026-01-143
ANDA 202425APOTEX2026-01-206

Official labeling on DailyMed

Showing the 12 most recent of 17 labels.

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