Mounjaro 25 mg/mL
tirzepatide · INJECTION, SOLUTION · Eli Lilly and Company
Mounjaro is a injection, solution containing tirzepatide at 25 mg/mL, taken subcutaneous. Manufactured by Eli Lilly and Company.
Key Facts
- Brand Name
- Mounjaro
- Generic Name
- tirzepatide
- NDC Code (Product)
0002-4612- Manufacturer
- Eli Lilly and Company
- Strength
- 25 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- NDA215866
- Drug Class
- Glucose-dependent Insulinotropic Polypeptide Receptor Agonist [EPC]; GLP-1 Receptor Agonist [EPC]
- Marketing Start
- 01/07/2026
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. MOUNJARO ® is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist 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. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended starting dosage is 2.5 mg injected subcutaneously once weekly. ( 2.1 ) After 4 weeks, increase to 5 mg injected subcutaneously once weekly. ( 2.1 ) If additional glycemic control is needed, increase the dosage in 2.5 mg increments after at least 4 weeks on the current dose. ( 2.1 ) Maximum dosage ( 2.1 ): Adults: 15 mg subcutaneously once weekly. Pediatric patients 10 years of age and older: 10 mg subcutaneously once weekly. Administer once weekly at any time of day, with or without meals. ( 2.2 ) Inject subcutaneously in the abdomen, thigh, or another person should inject in the back of the upper arm. Rotate injection sites with each dose. ( 2.2 ) Refer to the Full Prescribing Information for additional important administration instructions about MOUNJARO presentations. ( 2.2 ) 2.1 Recommended Dosage The recommended starting dosage of MOUNJARO is 2.5 mg injected subcutaneously once weekly [see Dosage and Administration ( 2.2 )] . Follow the dosage escalation below to reduce the risk of gastrointestinal adverse reactions [see Warnings and Precautions ( 5.6 ) and Adverse Reactions ( 6.1 )] . The 2.5 mg dosage is for treatment initiation an…
Contraindications
4 CONTRAINDICATIONS MOUNJARO is contraindicated in patients with: A personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Warnings and Precautions ( 5.1 )] . Known serious hypersensitivity to tirzepatide or any of the excipients in MOUNJARO. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with MOUNJARO [see Warnings and Precautions ( 5.4 )] . Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2. ( 4 ) Known serious hypersensitivity to tirzepatide or any of the excipients in MOUNJARO. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS MOUNJARO delays gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications. ( 7.2 ) 7.1 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin When initiating MOUNJARO, consider reducing the dose of concomitantly administered insulin secretagogues (e.g., sulfonylureas) or insulin to reduce the risk of hypoglycemia [see Warnings and Precautions ( 5.3 )]. 7.2 Oral Medications MOUNJARO delays gastric emptying and thereby has the potential to impact the absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with MOUNJARO. Monitor patients on oral medications dependent on threshold concentrations for efficacy and those with a narrow therapeutic index (e.g., warfarin) when concomitantly administered with MOUNJARO. Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation with MOUNJARO. Hormonal contraceptives that are not administered orally should not be aff…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: Risk of Thyroid C-cell Tumors [see Warnings and Precautions ( 5.1 )] Acute Pancreatitis [see Warnings and Precautions ( 5.2 )] Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin [see Warnings and Precautions ( 5.3 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.5 )] Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.6 )] Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy [see Warnings and Precautions ( 5.7 )] Acute Gallbladder Disease [see Warnings and Precautions ( 5.8 )] Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions ( 5.9 )] The most common adverse reactions, reported in ≥5% of patients treated with MOUNJARO are nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-108…
Frequently Asked Questions
What is Mounjaro used for?
Mounjaro contains tirzepatide. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is Mounjaro a controlled substance?
Mounjaro is not classified as a controlled substance by the DEA.
What is the generic name for Mounjaro?
The generic name for Mounjaro is tirzepatide. There are 6 other brand versions of tirzepatide.
What is the NDC code for Mounjaro 25 mg/mL?
The NDC (National Drug Code) for Mounjaro 25 mg/mL is 0002-4612, listed by Eli Lilly and Company.