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Active ingredient

Insulin Glargine

22 finished FDA listings contain Insulin Glargine as their only active ingredient; 1 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
INSULIN GLARGINE
Dosage forms
Injection, Solution, Liquid
Routes
Oral, Subcutaneous
Manufacturers / labelers
8
Strengths listed
100 [iu]/ml · 300 [iu]/ml · 300 u/ml · 9 [hp_x]/29.5ml
Brand names in FDA listings
Basaglar Kwikpen, Insulin 1556, Insulin Glargine, Insulin Glargine U-300, Insulin Glargine U-300 Max, Langlara, Lantus, Lantus Solostar, Rezvoglar Kwikpen, Semglee, Toujeo, Toujeo Max

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 274783

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
BLA 021081SANOFI AVENTIS US2000-04-205
BLA 206538SANOFI US SERVICES2015-02-256
BLA 205692ELI LILLY AND CO2015-12-161
BLA 761201MYLAN PHARMS INC2021-07-286
BLA 761215ELI LILLY CO2021-12-172
BLA 761412SUNSHINE LAKE PHARMA CO LTD2026-04-291

Official labeling on DailyMed

Showing the 12 most recent of 16 labels.

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