Is Zepbound the Same as Mounjaro? What the Two FDA Labels Say

Zepbound and Mounjaro contain the same active ingredient, tirzepatide, and Eli Lilly and Company makes both. They are still two different FDA-approved products. Each one has its own name, its own new drug application and its own label, and the two labels list different uses.

This guide puts the two labels side by side. Every fact below comes from the FDA-approved prescribing information on DailyMed, read through FDA's openFDA service on September 29, 2026, or from FDA's Drugs@FDA records read the same day. Quotes are word for word. The labels print brand names in capital letters, and the quotes keep that.

The page does not reprint the amounts, schedules or clinical study figures in either label. Those belong to the label itself and to the physician who reads it with you.

Zepbound vs Mounjaro at a glance: what each label says

Do Zepbound and Mounjaro contain the same active ingredient?

Yes. Section 11 of the Zepbound label opens: "ZEPBOUND (tirzepatide) injection, for subcutaneous use, contains tirzepatide, a GIP receptor and GLP-1 receptor agonist." Section 11 of the Mounjaro label opens with the same words, "MOUNJARO (tirzepatide) injection, for subcutaneous use, contains tirzepatide", and continues with a description of the drug class.

Both descriptions give the same molecular weight, empirical formula and inactive ingredients. Apart from the brand name and one short phrase, section 11 reads the same on both labels.

So is tirzepatide the same as Mounjaro? Not quite. Tirzepatide is the ingredient. Mounjaro is one brand-name product that contains it, and Zepbound is another.

Each label then explains the mechanism with a different emphasis. Section 12.1 of the Zepbound label says: "GLP-1 is a physiological regulator of appetite and caloric intake." Section 12.1 of the Mounjaro label says: "Tirzepatide enhances first- and second-phase insulin secretion, and reduces glucagon levels, both in a glucose-dependent manner." Each label describes the one molecule from the side of its own approved use. For background on the drug class, see what a GLP-1 medication is.

What is each one FDA-approved to treat?

This is where the two labels differ. Here is section 1 of each, word for word.

The Zepbound label: "ZEPBOUND is indicated in combination with a reduced-calorie diet and increased physical activity: to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity."

The Mounjaro 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."

Three plain points follow from those two paragraphs.

• Section 1 of the Mounjaro label does not list weight reduction as an approved use.
• Section 1 of the Zepbound label does not list blood sugar control in type 2 diabetes as an approved use.
• Only the Zepbound label lists obstructive sleep apnea, and only the Mounjaro label lists children.

Both lists have grown since the first approvals. FDA's approval letter for Zepbound supplement S-013 "provides for the addition of a new indication for Zepbound: to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity." Drugs@FDA dates that approval December 20, 2024. FDA's approval letter for Mounjaro supplements S-044 and S-045 records "the addition of a new indication as a treatment to reduce the risk of major adverse cardiovascular (CV) events" in adults with type 2 diabetes mellitus who are at high risk for these events. Drugs@FDA dates that approval August 27, 2026.

Why does one molecule have two brand names?

FDA's own records show how it happened. They do not show why, and this page does not guess.

FDA's Drugs@FDA data classifies the original Mounjaro application, NDA 215866, as "Type 1 - New Molecular Entity." It was approved May 13, 2022. The same data classifies the original Zepbound application, NDA 217806, as "Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated." It was approved November 8, 2023.

In plain words, the weight management use came to FDA as its own new drug application, not as an addition to the Mounjaro application. FDA's approval letter for Zepbound describes that application as providing "for the use of Zepbound (tirzepatide) injection as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults" who met body mass index criteria stated in the letter.

A separate application brings a separate approval, a separate label and a separate brand name. It also brings separate product codes. Section 16 of each label lists its own National Drug Code numbers, and none of them appears on both labels.

Neither product is a generic of the other. Both are brand-name products under their own new drug applications. For what a generic legally is, see whether a generic Zepbound exists.

Do the two labels carry the same boxed warning?

Yes. A boxed warning is the prominent warning at the top of a prescription label. Both labels carry one with the same title: "WARNING: RISK OF THYROID C-CELL TUMORS."

The Zepbound box, in its highlights form, reads: "In rats, tirzepatide causes thyroid C-cell tumors. It is unknown whether ZEPBOUND causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined."

The Mounjaro box, in its highlights form, reads: "Tirzepatide causes thyroid C-cell tumors in rats. It is unknown whether MOUNJARO causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined."

Both boxes then state that the product "is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)." Both tell prescribers to inform patients "of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness)."

Section 4 of each label lists the same two contraindications. The first is that personal or family history. The second is a known serious hypersensitivity to tirzepatide or to any of the inactive ingredients. The label warnings are covered in more depth in Zepbound side effects.

Which other warnings appear on both labels?

Section 5 of each label, "Warnings and Precautions," has ten headings. The topics match. The order differs, and two headings are worded differently.

Source: DailyMed, section 5 of each label; Zepbound label updated August 28, 2026, Mounjaro label updated August 27, 2026; read September 29, 2026.

The low blood sugar heading on the Mounjaro label names insulin and insulin secretagogues, and the two eye headings describe different groups of patients. The text under each heading is what a prescriber reads.

How are Zepbound and Mounjaro supplied: pens and vials

Section 3 of both labels lists the same forms, in the same words: "pre-filled single-dose pens, single-dose vials, multi-dose vials, or single-patient-use KwikPens."

All four are injections under the skin, and neither label lists a tablet. Each label also lists the amounts available in each form; this page does not reprint them.

Because the products share forms, the name on the carton is what tells them apart. Each carton carries its own brand name and its own National Drug Code number. Both labels also carry the same warning about the KwikPen: never share one between patients, even if the pen needle is changed.

For the multi-use pen, see the Zepbound KwikPen. For storage, see whether Zepbound needs to be refrigerated, which also covers Mounjaro. For where the labels say to inject, see Zepbound injection sites.

Can one be used in place of the other?

The labels and the FDA records answer only part of this question. Here is what they say.

• Neither label names the other product. Both full texts were searched through openFDA on September 29, 2026.
• Neither label says that one product may be used in place of the other.
• Drugs@FDA lists the two under separate applications, NDA 217806 and NDA 215866, each approved for its own uses.
• Section 1 of the Zepbound label says: "ZEPBOUND contains tirzepatide. Coadministration with other tirzepatide-containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended." Mounjaro is a tirzepatide-containing product, so the Zepbound label advises against using the two together.

The labels do not address what a pharmacy may do with a prescription for either product. That question goes to the prescriber and the pharmacist, with the prescription in hand.

Why might a health plan cover one and not the other?

Coverage depends on the indication and the plan. This page does not predict what any plan will do.

Two plan terms explain why the answer can differ between the products. HealthCare.gov defines a formulary as "A list of prescription drugs covered by a prescription drug plan or another insurance plan offering prescription drug benefits." It defines prior authorization as "Approval from a health plan that may be required before you get a service or fill a prescription in order for the service or prescription to be covered by your plan."

Zepbound and Mounjaro are separate products with separate labels. A plan's list can include one, both or neither. When a plan requires prior authorization, the request describes what the medicine is prescribed for, and the two labels list different uses.

Questions for the plan:

• Is Zepbound on the formulary? Is Mounjaro?
• Is prior authorization required for either one, and what does the plan ask for?
• Does coverage differ by diagnosis?

Who decides which one, if either, is appropriate?

A licensed physician does. The prescribing information is written for health care professionals, and each product also comes with a Medication Guide written for patients. Medication is prescribed only if a licensed physician determines it is appropriate, and the answer can be neither product.

Useful questions for that conversation:

1. Which of my diagnoses matches section 1 of either label?
2. Does anything in section 4 or in the boxed warning apply to me or my family history?
3. Which warnings in section 5 matter for my health history?
4. I take other medicines. Does the Limitations of Use line on the Zepbound label, or any other part of either label, apply to them?
5. Which form would I use, and who will show me how to use it?

Where can you read each label yourself?

Both labels are public and free to read.

1. Open DailyMed, the National Library of Medicine's label library, and search for the brand name.
2. Check the set id. Zepbound is 487cd7e7-434c-4925-99fa-aa80b1cc776b. Mounjaro is d2d7da5d-ad07-4228-955f-cf7e355c8cc0.
3. Note the "updated" date on the page. On September 29, 2026, DailyMed showed August 28, 2026 for Zepbound and August 27, 2026 for Mounjaro.
4. Read section 1 for the approved uses, the boxed warning at the top, section 4 for contraindications and section 5 for warnings.
5. For the approval history, open Drugs@FDA and search NDA 217806 or NDA 215866.

For help with the layout of a label, see how to read a prescription label.

What the primary sources say

• Eli Lilly and Company via DailyMed, Zepbound (tirzepatide) prescribing information, set id 487cd7e7-434c-4925-99fa-aa80b1cc776b, updated August 28, 2026 (accessed September 29, 2026): "to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition"; "to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity"; "In rats, tirzepatide causes thyroid C-cell tumors."; "Coadministration with other tirzepatide-containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended."; "The safety and effectiveness of ZEPBOUND have not been established in pediatric patients."
• Eli Lilly and Company via DailyMed, Mounjaro (tirzepatide) prescribing information, set id d2d7da5d-ad07-4228-955f-cf7e355c8cc0, updated August 27, 2026 (accessed September 29, 2026): "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"; "Tirzepatide causes thyroid C-cell tumors in rats."
• U.S. Food and Drug Administration, Drugs@FDA and openFDA application data, NDA 217806 and NDA 215866 (accessed September 29, 2026): Zepbound original approval 11/08/2023, "Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated"; Mounjaro original approval 05/13/2022, "Type 1 - New Molecular Entity"
• U.S. Food and Drug Administration, approval letter, NDA 217806 (accessed September 29, 2026): "This NDA provides for the use of Zepbound (tirzepatide) injection as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults" (the sentence continues with body mass index criteria)
• U.S. Food and Drug Administration, supplement approval letter, NDA 217806 S-013 (accessed September 29, 2026): "provides for the addition of a new indication for Zepbound: to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity."
• U.S. Food and Drug Administration, supplement approval letter, NDA 215866 S-044 and S-045 (accessed September 29, 2026): "the addition of a new indication as a treatment to reduce the risk of major adverse cardiovascular (CV) events"
• HealthCare.gov Glossary, Formulary and Prior authorization (accessed September 29, 2026): "A list of prescription drugs covered by a prescription drug plan or another insurance plan offering prescription drug benefits."; "Approval from a health plan that may be required before you get a service or fill a prescription in order for the service or prescription to be covered by your plan."

Every source is listed with its address below.

This article is for informational purposes only and does not constitute medical advice. Medication is prescribed only if a licensed physician determines it is appropriate. Label sentences are quoted word for word from the FDA-approved prescribing information named above, as published on DailyMed on the dates shown. Labels change, so read the current label and the Medication Guide that came with your own medicine.