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Active ingredient

Tirzepatide

54 finished FDA listings contain Tirzepatide as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
TIRZEPATIDE
Dosage forms
Injection, Solution
Routes
Subcutaneous
Manufacturers / labelers
2
Strengths listed
10 mg/.5ml · 12.5 mg/.5ml · 12.5 mg/ml · 15 mg/.5ml · 16.7 mg/ml · 2.5 mg/.5ml · 20.8 mg/ml · 25 mg/ml · 4.17 mg/ml · 5 mg/.5ml · 7.5 mg/.5ml · 8.33 mg/ml
Brand names in FDA listings
Mounjaro, Mounjaro Kwikpen, Zepbound, Zepbound Kwikpen

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 2601723

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 215866ELI LILLY AND CO2022-05-1330
NDA 217806ELI LILLY AND CO2023-11-0824

Official labeling on DailyMed

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