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Active ingredient

Insulin Lispro

29 finished FDA listings contain Insulin Lispro as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
INSULIN LISPRO
Dosage forms
Injection, Solution, Injection, Suspension
Routes
Intravenous, Subcutaneous
Manufacturers / labelers
4
Strengths listed
100 [iu]/ml · 100 u/ml · 200 [iu]/ml
Brand names in FDA listings
Admelog, Humalog, Humalog Junior Kwikpen, Humalog Kwikpen, Humalog Mix50/50 Kwikpen, Humalog Mix75/25, Humalog Mix75/25 Kwikpen, Humalog Tempo Pen, Insulin Lispro Junior Kwikpen, Insulin Lispro Kwikpen, Insulin Lispro Protamine And Insulin Lispro Injectable Suspension Mix75/25 Kwikpen, Lyumjev, Lyumjev Junior Kwikpen, Lyumjev Kwikpen, Lyumjev Tempo Pen

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 86009

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 020563LILLY1996-06-1413
BLA 021017LILLY1999-12-223
BLA 021018LILLY1999-12-221
BLA 205747ELI LILLY AND CO2015-05-261
BLA 209196SANOFI-AVENTIS US2017-12-114
BLA 761109ELI LILLY AND CO2020-06-157

Official labeling on DailyMed

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