Quick answers
- What is Tirzepatide used for?
- The FDA-approved label (Mounjaro, Eli Lilly and Company, August 27, 2026) says: “MOUNJARO ® is indicated: as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction (MI), or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tirzepatide have a boxed warning?
- Yes. The FDA label for Mounjaro has a boxed warning (“WARNING: RISK OF THYROID C-CELL TUMORS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Tirzepatide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tirzepatide been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Tirzepatide?
- 2 companies list prescription products of Tirzepatide in the FDA NDC Directory, including Eli Lilly and Company and A-S Medication Solutions.
What Tirzepatide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
MOUNJARO ® is indicated: as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction (MI), or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events. …
— FDA label: Mounjaro, Eli Lilly and Company, effective August 27, 2026. Read the full label on DailyMed →
The FDA has 8 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: RISK OF THYROID C-CELL TUMORS
. Read it on the full label →
8 of 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 54 in the FDA NDC Directory |
| Brand names | Mounjaro, Zepbound, Mounjaro Kwikpen, Zepbound Kwikpen |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| tirzepatide 10 mg/0.5 mL injection, solution | Brand: Mounjaro | $538.76 per mL |
| tirzepatide 10 mg/0.5 mL injection, solution | Brand: Zepbound | $526.07 per mL |
| tirzepatide 12.5 mg/0.5 mL injection, solution | Brand: Mounjaro | $538.59 per mL |
| tirzepatide 12.5 mg/0.5 mL injection, solution | Brand: Zepbound | $525.83 per mL |
| tirzepatide 12.5 mg/mL injection, solution | Brand: Zepbound KwikPen | $201.16 per mL |
| tirzepatide 15 mg/0.5 mL injection, solution | Brand: Mounjaro | $538.57 per mL |
| tirzepatide 15 mg/0.5 mL injection, solution | Brand: Zepbound | $525.93 per mL |
| tirzepatide 16.7 mg/mL injection, solution | Brand: Zepbound KwikPen | $281.78 per mL |
| tirzepatide 2.5 mg/0.5 mL injection, solution | Brand: Mounjaro | $538.75 per mL |
| tirzepatide 2.5 mg/0.5 mL injection, solution | Brand: Zepbound | $526.23 per mL |
| tirzepatide 20.8 mg/mL injection, solution | Brand: Zepbound KwikPen | $282.23 per mL |
| tirzepatide 25 mg/mL injection, solution | Brand: Zepbound KwikPen | $281.68 per mL |
| tirzepatide 4.17 mg/mL injection, solution | Brand: Zepbound KwikPen | $201.39 per mL |
| tirzepatide 5 mg/0.5 mL injection, solution | Brand: Mounjaro | $538.70 per mL |
| tirzepatide 5 mg/0.5 mL injection, solution | Brand: Zepbound | $526.10 per mL |
| tirzepatide 7.5 mg/0.5 mL injection, solution | Brand: Mounjaro | $538.74 per mL |
| tirzepatide 7.5 mg/0.5 mL injection, solution | Brand: Zepbound | $526.04 per mL |
| tirzepatide 8.33 mg/mL injection, solution | Brand: Zepbound KwikPen | $201.20 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Eli Lilly and Company48 products
- A-S Medication Solutions6 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA215866 MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | Eli Lilly and Co | May 13, 2022 | 12, latest August 27, 2026 2026: Efficacy · 2026: Efficacy · 2026: Labeling |
| NDA217806 ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | Eli Lilly and Co | November 8, 2023 | 13, latest August 26, 2026 2026: Efficacy · 2026: Labeling · 2026: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Mounjaro, Eli Lilly and Company, effective August 27, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →