NDC 0002-1457Prescription (Rx only)FDA NDA · NDA215866

Mounjaro

Active substance: Tirzepatide

30 formulations • 49 package configurations

All 79 registered NDCs — click to copy

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Mounjaro (Tirzepatide) NDC 0002-1457 converts to 00002-1457-80 for billing and bills under J3490 at Per single-dose pen.

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Listing: 0002-1457

Billing & reimbursement crosswalk

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

00002-1457-80

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.

Administered Patient Dose

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 (N40002145780)

Every registered strength and package for Mounjaro, with 10-digit and 11-digit NDC formats
Formulation / role	Package NDC	Product NDC	11-digit HIPAA	Packaging detail
7.5 mg/.5mL	0002-1484-80	0002-1484	00002-1484-80	4 SYRINGE in 1 CARTON (0002-1484-80) / .5 mL in 1 SYRINGE (0002-1484-01)
Prefilled syringe	0002-1484-01	0002-1484	00002-1484-01	Inner component of kit (0002-1484-80)
20.8 mg/mL	0002-3422-11	0002-3422	00002-3422-11	1 SYRINGE in 1 CARTON (0002-3422-11) / 2.4 mL in 1 SYRINGE (0002-3422-01)
Prefilled syringe	0002-3422-01	0002-3422	00002-3422-01	Inner component of kit (0002-3422-11)
8.33 mg/mL	0002-3455-11	0002-3455	00002-3455-11	1 SYRINGE in 1 CARTON (0002-3455-11) / 2.4 mL in 1 SYRINGE (0002-3455-01)
Prefilled syringe	0002-3455-01	0002-3455	00002-3455-01	Inner component of kit (0002-3455-11)
4.17 mg/mL	0002-4052-11	0002-4052	00002-4052-11	1 VIAL, MULTI-DOSE in 1 CARTON (0002-4052-11) / 2.4 mL in 1 VIAL, MULTI-DOSE (0002-4052-01)
Vial component	0002-4052-01	0002-4052	00002-4052-01	Inner component of kit (0002-4052-11)
15 mg/.5mL	0002-1457-80	0002-1457	00002-1457-80	4 SYRINGE in 1 CARTON (0002-1457-80) / .5 mL in 1 SYRINGE (0002-1457-01)
Prefilled syringe	0002-1457-01	0002-1457	00002-1457-01	Inner component of kit (0002-1457-80)
12.5 mg/.5mL	0002-2423-01	0002-2423	00002-2423-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0002-2423-01) / .5 mL in 1 VIAL, SINGLE-DOSE
20.8 mg/mL	0002-4523-11	0002-4523	00002-4523-11	1 VIAL, MULTI-DOSE in 1 CARTON (0002-4523-11) / 2.4 mL in 1 VIAL, MULTI-DOSE (0002-4523-01)
Vial component	0002-4523-01	0002-4523	00002-4523-01	Inner component of kit (0002-4523-11)
2.5 mg/.5mL	0002-1152-01	0002-1152	00002-1152-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0002-1152-01) / .5 mL in 1 VIAL, SINGLE-DOSE
16.7 mg/mL	0002-3433-11	0002-3433	00002-3433-11	1 SYRINGE in 1 CARTON (0002-3433-11) / 2.4 mL in 1 SYRINGE (0002-3433-01)
Prefilled syringe	0002-3433-01	0002-3433	00002-3433-01	Inner component of kit (0002-3433-11)
4.17 mg/mL	0002-3466-11	0002-3466	00002-3466-11	1 SYRINGE in 1 CARTON (0002-3466-11) / 2.4 mL in 1 SYRINGE (0002-3466-01)
Prefilled syringe	0002-3466-01	0002-3466	00002-3466-01	Inner component of kit (0002-3466-11)
12.5 mg/.5mL	0002-1460-80	0002-1460	00002-1460-80	4 SYRINGE in 1 CARTON (0002-1460-80) / .5 mL in 1 SYRINGE (0002-1460-01)
Prefilled syringe	0002-1460-01	0002-1460	00002-1460-01	Inner component of kit (0002-1460-80)
8.33 mg/mL	0002-4103-11	0002-4103	00002-4103-11	1 VIAL, MULTI-DOSE in 1 CARTON (0002-4103-11) / 2.4 mL in 1 VIAL, MULTI-DOSE (0002-4103-01)
Vial component	0002-4103-01	0002-4103	00002-4103-01	Inner component of kit (0002-4103-11)
5 mg/.5mL	0002-1495-80	0002-1495	00002-1495-80	4 SYRINGE in 1 CARTON (0002-1495-80) / .5 mL in 1 SYRINGE (0002-1495-01)
Prefilled syringe	0002-1495-01	0002-1495	00002-1495-01	Inner component of kit (0002-1495-80)
10 mg/.5mL	0002-2340-01	0002-2340	00002-2340-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0002-2340-01) / .5 mL in 1 VIAL, SINGLE-DOSE
25 mg/mL	0002-4612-11	0002-4612	00002-4612-11	1 VIAL, MULTI-DOSE in 1 CARTON (0002-4612-11) / 2.4 mL in 1 VIAL, MULTI-DOSE (0002-4612-01)
Vial component	0002-4612-01	0002-4612	00002-4612-01	Inner component of kit (0002-4612-11)
16.7 mg/mL	0002-4304-11	0002-4304	00002-4304-11	1 VIAL, MULTI-DOSE in 1 CARTON (0002-4304-11) / 2.4 mL in 1 VIAL, MULTI-DOSE (0002-4304-01)
Vial component	0002-4304-01	0002-4304	00002-4304-01	Inner component of kit (0002-4304-11)
25 mg/mL	0002-3411-11	0002-3411	00002-3411-11	1 SYRINGE in 1 CARTON (0002-3411-11) / 2.4 mL in 1 SYRINGE (0002-3411-01)
Prefilled syringe	0002-3411-01	0002-3411	00002-3411-01	Inner component of kit (0002-3411-11)
12.5 mg/mL	0002-3444-11	0002-3444	00002-3444-11	1 SYRINGE in 1 CARTON (0002-3444-11) / 2.4 mL in 1 SYRINGE (0002-3444-01)
Prefilled syringe	0002-3444-01	0002-3444	00002-3444-01	Inner component of kit (0002-3444-11)
10 mg/.5mL	50090-8021-0	50090-8021	50090-8021-00	4 SYRINGE in 1 CARTON (50090-8021-0) / .5 mL in 1 SYRINGE
12.5 mg/.5mL	50090-8022-0	50090-8022	50090-8022-00	4 SYRINGE in 1 CARTON (50090-8022-0) / .5 mL in 1 SYRINGE
15 mg/.5mL	50090-8026-0	50090-8026	50090-8026-00	4 SYRINGE in 1 CARTON (50090-8026-0) / .5 mL in 1 SYRINGE
7.5 mg/.5mL	50090-8023-0	50090-8023	50090-8023-00	4 SYRINGE in 1 CARTON (50090-8023-0) / .5 mL in 1 SYRINGE
5 mg/.5mL	50090-8024-0	50090-8024	50090-8024-00	4 SYRINGE in 1 CARTON (50090-8024-0) / .5 mL in 1 SYRINGE
2.5 mg/.5mL	50090-8025-0	50090-8025	50090-8025-00	4 SYRINGE in 1 CARTON (50090-8025-0) / .5 mL in 1 SYRINGE
10 mg/.5mL	0002-1471-80	0002-1471	00002-1471-80	4 SYRINGE in 1 CARTON (0002-1471-80) / .5 mL in 1 SYRINGE (0002-1471-01)
Prefilled syringe	0002-1471-01	0002-1471	00002-1471-01	Inner component of kit (0002-1471-80)
12.5 mg/mL	0002-4210-11	0002-4210	00002-4210-11	1 VIAL, MULTI-DOSE in 1 CARTON (0002-4210-11) / 2.4 mL in 1 VIAL, MULTI-DOSE (0002-4210-01)
Vial component	0002-4210-01	0002-4210	00002-4210-01	Inner component of kit (0002-4210-11)
2.5 mg/.5mL	0002-1506-61	0002-1506	00002-1506-61	4 SYRINGE in 1 CARTON (0002-1506-61) / .5 mL in 1 SYRINGESample
2.5 mg/.5mL	0002-1506-80	0002-1506	00002-1506-80	4 SYRINGE in 1 CARTON (0002-1506-80) / .5 mL in 1 SYRINGE (0002-1506-01)
Prefilled syringe	0002-1506-01	0002-1506	00002-1506-01	Inner component of kit (0002-1506-80)
7.5 mg/.5mL	0002-2214-01	0002-2214	00002-2214-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0002-2214-01) / .5 mL in 1 VIAL, SINGLE-DOSE
5 mg/.5mL	0002-1243-01	0002-1243	00002-1243-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0002-1243-01) / .5 mL in 1 VIAL, SINGLE-DOSE
15 mg/.5mL	0002-3002-01	0002-3002	00002-3002-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0002-3002-01) / .5 mL in 1 VIAL, SINGLE-DOSE

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 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

INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

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.

DOSAGE FORMS AND STRENGTHS

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)

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). • Known serious hypersensitivity to tirzepatide or any of the excipients in MOUNJARO.

WARNINGS AND PRECAUTIONS

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.

ADVERSE 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%)

HOW SUPPLIED / STORAGE AND HANDLING

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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G-Protein-linked Receptor Interactions

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Terms used here11-digit NDC Billable unit N4 qualifier

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Mounjaro — J3490

Eli Lilly and Company

G-Protein-linked Receptor Interactions