NDC 0002-3455Prescription (Rx only)FDA NDA · NDA215866

Mounjaro KwikPen

Active substance: Tirzepatide

FDA labeler: Eli Lilly and Company

6 formulations • 12 package configurations
All 18 registered NDCs — click to copy
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Mounjaro KwikPen (Tirzepatide) NDC 0002-3455 converts to 00002-3455-11 for billing and bills under J3490 at Per single-dose pen.

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Listing: 0002-3455
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NDC • HCPCS Level II • CPT administration

HCPCS Level II J-Code
J3490
Unclassified drugs / Tirzepatide
Billable unit: Per single-dose pen
11-digit HIPAA NDC
00002-3455-11
Zero-padded 5-4-2 format
Standard conversion
CPT administration code
96372
Therapeutic, prophylactic, or diagnostic injection; subcutaneous or intramuscular
UB-04 revenue code
Rev 0636
0636 (Pharmacy - Extension of 0250 Drugs Requiring Detail)
Qualifier: ML

Interactive Unit Multiplier Calculator

J3490

Calculate the exact number of billable HCPCS units to report on CMS-1500 / 837P claims based on the patient dose and single-dose vial waste.

MG
Units to report on claim:
100 Units
Based on 1 mg = 1 billable unit (100.0 exact)
Box 24 / HCPCS Quantity Formatted Line:J3490 UN100 (N40002345511)
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All registered strengths & packaging

Every registered strength and package for Mounjaro KwikPen, with 10-digit and 11-digit NDC formats
Formulation / rolePackage NDCProduct NDC11-digit HIPAAPackaging detailCopy
20.8 mg/mL0002-3422-110002-342200002-3422-111 SYRINGE in 1 CARTON (0002-3422-11) / 2.4 mL in 1 SYRINGE (0002-3422-01)
Prefilled syringe0002-3422-010002-342200002-3422-01Inner component of kit (0002-3422-11)
8.33 mg/mL0002-3455-110002-345500002-3455-111 SYRINGE in 1 CARTON (0002-3455-11) / 2.4 mL in 1 SYRINGE (0002-3455-01)
Prefilled syringe0002-3455-010002-345500002-3455-01Inner component of kit (0002-3455-11)
16.7 mg/mL0002-3433-110002-343300002-3433-111 SYRINGE in 1 CARTON (0002-3433-11) / 2.4 mL in 1 SYRINGE (0002-3433-01)
Prefilled syringe0002-3433-010002-343300002-3433-01Inner component of kit (0002-3433-11)
4.17 mg/mL0002-3466-110002-346600002-3466-111 SYRINGE in 1 CARTON (0002-3466-11) / 2.4 mL in 1 SYRINGE (0002-3466-01)
Prefilled syringe0002-3466-010002-346600002-3466-01Inner component of kit (0002-3466-11)
25 mg/mL0002-3411-110002-341100002-3411-111 SYRINGE in 1 CARTON (0002-3411-11) / 2.4 mL in 1 SYRINGE (0002-3411-01)
Prefilled syringe0002-3411-010002-341100002-3411-01Inner component of kit (0002-3411-11)
12.5 mg/mL0002-3444-110002-344400002-3444-111 SYRINGE in 1 CARTON (0002-3444-11) / 2.4 mL in 1 SYRINGE (0002-3444-01)
Prefilled syringe0002-3444-010002-344400002-3444-01Inner component of kit (0002-3444-11)
FDA drug label

Prescribing information

Taken from the manufacturer's FDA Structured Product Labeling submission. This is the label as filed, not a summary. Initial U.S. approval: 2022.

FDA boxed warning
WARNING: RISK OF THYROID C-CELL TUMORS • In rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether MOUNJARO causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. • MOUNJARO is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Highlights

These highlights do not include all the information needed to use Mounjaro KwikPen safely and effectively. The full sections follow.

Indications and usage
MOUNJARO is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: Has not been studied in patients with a history of pancreatitis. Not indicated for use in type 1 diabetes mellitus.
Dosage and administration
• Subcutaneous injection once weekly in abdomen, thigh, or upper arm. • Initiate at 2.5 mg once weekly. After 4 weeks, increase to 5 mg once weekly. • If additional glycemic control is needed, increase in 2.5 mg increments after at least 4 weeks on current dose. • Maximum dosage is 15 mg once weekly.
Dosage forms and strengths
Single-dose auto-injector pen: 2.5 mg/0.5 mL, 5 mg/0.5 mL, 7.5 mg/0.5 mL, 10 mg/0.5 mL, 12.5 mg/0.5 mL, 15 mg/0.5 mL.
Contraindications
Personal or family history of Medullary Thyroid Carcinoma (MTC) or MEN 2 syndrome. Known severe hypersensitivity to tirzepatide.
Warnings and precautions
• Pancreatitis: Discontinue promptly if pancreatitis is suspected. • Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin. • Severe Gastrointestinal Disease: Not recommended in severe gastroparesis. • Diabetic Retinopathy Complications in patients with a history of retinopathy. • Acute Kidney Injury and Acute Gallbladder Disease.
Adverse reactions
Most common adverse reactions (≥5%): nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain.
7 Label Sections
MOUNJARO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: • MOUNJARO has not been studied in patients with a history of pancreatitis [see Warnings and Precautions (5.2)]. • MOUNJARO is not indicated for use in patients with type 1 diabetes mellitus.
2.1 Recommended Dosage • The recommended starting dosage is 2.5 mg injected subcutaneously once weekly. The 2.5 mg dosage is for treatment initiation and is not effective for glycemic control. • After 4 weeks, increase the dosage to 5 mg once weekly. • If additional glycemic control is needed, increase the dosage in 2.5 mg increments after at least 4 weeks on the current dose. • The maximum dosage is 15 mg injected subcutaneously once weekly. 2.2 Administration Instructions • Administer MOUNJARO once weekly, any time of day, with or without food. • Inject subcutaneously in the abdomen, thigh, or upper arm. Rotate injection sites with each dose.
Injection: Clear, colorless to slightly yellow solution in pre-filled single-dose pens delivering: • 2.5 mg/0.5 mL (NDC 0002-1401-01) • 5 mg/0.5 mL (NDC 0002-1402-01) • 7.5 mg/0.5 mL (NDC 0002-1403-01) • 10 mg/0.5 mL (NDC 0002-1404-01) • 12.5 mg/0.5 mL (NDC 0002-1405-01) • 15 mg/0.5 mL (NDC 0002-1406-01)
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). • Known serious hypersensitivity to tirzepatide or any of the excipients in MOUNJARO.
5.1 Risk of Thyroid C-Cell Tumors Counsel patients regarding the potential risk for MTC and symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). 5.2 Pancreatitis Acute pancreatitis has been observed in clinical trials. If pancreatitis is suspected, discontinue MOUNJARO. 5.3 Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin The risk of hypoglycemia is increased when MOUNJARO is used in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin. 5.4 Acute Kidney Injury Monitor renal function when initiating or escalating doses of MOUNJARO in patients reporting severe adverse gastrointestinal reactions.
In clinical trials, adverse reactions reported in ≥5% of patients treated with MOUNJARO included: • Nausea (12% to 18%) • Diarrhea (12% to 17%) • Decreased appetite (5% to 11%) • Vomiting (5% to 9%) • Constipation (6% to 7%) • Dyspepsia (5% to 8%) • Abdominal pain (5% to 6%)
Store MOUNJARO in the refrigerator between 2°C to 8°C (36°F to 46°F). If needed, each single-dose pen may be stored unrefrigerated at temperatures up to 30°C (86°F) for up to 21 days. Do not freeze. Protect from light.
Billing code

Mounjaro — J3490

Unclassified drugs / Tirzepatide (Mounjaro). Billed at Per single-dose pen.

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Labeler

Eli Lilly and Company

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Pharmacologic class

G-Protein-linked Receptor Interactions

Every other National Drug Code registered in the same established class.

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