Quick answers
- What is Mounjaro KwikPen?
- Mounjaro KwikPen is a brand name of Tirzepatide, a prescription medicine. The FDA NDC Directory lists 6 Mounjaro KwikPen products in 6 strengths and forms.
- Who makes Mounjaro KwikPen?
- Eli Lilly and Co holds the FDA application for Mounjaro KwikPen (NDA215866, approved May 13, 2022).
- Is there a generic or store brand of Mounjaro KwikPen?
- Yes. The FDA NDC Directory lists 18 other products with the same active ingredients, strength and form as a Mounjaro KwikPen product. Ask your pharmacist whether one is right for you.
- Has Mounjaro KwikPen been recalled?
- No recall linked to Mounjaro KwikPen products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Mounjaro KwikPen is
Each Mounjaro KwikPen product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Tirzepatide · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| tirzepatide 12.5 mg/mL injection, solution (subcutaneous) | Mounjaro KwikPen | 3 products, 1 company | DailyMed |
| tirzepatide 16.7 mg/mL injection, solution (subcutaneous) | Mounjaro KwikPen | 3 products, 1 company | DailyMed |
| tirzepatide 20.8 mg/mL injection, solution (subcutaneous) | Mounjaro KwikPen | 3 products, 1 company | DailyMed |
| tirzepatide 25 mg/mL injection, solution (subcutaneous) | Mounjaro KwikPen | 3 products, 1 company | DailyMed |
| tirzepatide 4.17 mg/mL injection, solution (subcutaneous) | Mounjaro KwikPen | 3 products, 1 company | DailyMed |
| tirzepatide 8.33 mg/mL injection, solution (subcutaneous) | Mounjaro KwikPen | 3 products, 1 company | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Tirzepatide →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA215866 | Eli Lilly and Co | May 13, 2022 | 6 |
Companies that list Mounjaro KwikPen
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Mounjaro KwikPen products.
- Eli Lilly and Company6 products
Recalls
No recall linked to Mounjaro KwikPen products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.