Prescription drug · NDA
Mounjaro KwikPen (tirzepatide) NDC 0002-3422
Tirzepatide 20.8 mg/mL · Injection, Solution · Subcutaneous · Eli Lilly and Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0002-3422-11 | 00002342211 | 1 SYRINGE in 1 CARTON (0002-3422-11) / 2.4 mL in 1 SYRINGE (0002-3422-01)Marketed from Jan 20, 2026 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Mounjaro KwikPenSuffix: KwikPen
- Generic name (nonproprietary)
- tirzepatide
- Active ingredients
- Tirzepatide — 20.8 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Eli Lilly and Company
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215866
- Marketing start
- Listing expires
- Other FDA classes
- G-Protein-linked Receptor Interactions (Mechanism)Glucagon-like Peptide-1 (GLP-1) Agonists (Mechanism)
- Identifiers
- Product ID 0002-3422_8f6367b6-bf0d-46e1-ba7d-0417523474e5SPL ID 8f6367b6-bf0d-46e1-ba7d-0417523474e5SPL set ID d2d7da5d-ad07-4228-955f-cf7e355c8cc0RxCUI 2601743, 2601746, 2601755, 2601758, 2601761, 2601764, 2601767, 2601770, 2601773, 2601776, 2601784, 2601785, 2644396, 2644399, 2644401, 2644403, 2644405, 2644407, 2644409, 2644411, 2644413, 2644415, 2644417, 2644419, 2732437, 2732442, 2732446, 2732449, 2732452, 2732456, 2733666, 2733668, 2733670, 2733671, 2733673, 2733675, 2734623, 2734628, 2734632, 2734636, 2734640, 2734644, 2735286, 2735288, 2735290, 2735292, 2735294, 2735297UNII OYN3CCI6QEUPC 0300023002013, 0300021152017, 0300022423017, 0300024612112, 0300024052116, 0300024304116, 0300021243012, 0300024523111
- Pharmacologic class
- GLP-1 Receptor Agonist; Glucose-dependent Insulinotropic Polypeptide Receptor Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeMed-Code curated
No drug-specific HCPCS code in Med-Code’s directory for this product.
Med-Code's directory has no drug-specific HCPCS code for Mounjaro. It is usually self-administered and billed by NDC through a pharmacy benefit.
If a payer accepts an unclassified code for it in a clinical setting, that would be J3490 (Unclassified drugs), with the NDC, quantity and often the invoice. Acceptance varies by payer.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400002342211followed by a unit qualifier and the quantityPackage 00002-3422-11. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the 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. 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 ) to reduce t…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 215866
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Mounjaro KwikPentirzepatide | Tirzepatide 16.7 mg/mL | Injection, SolutionSubcutaneous | Eli Lilly and Company | 0002-3433 |
| Mounjaro KwikPentirzepatide | Tirzepatide 4.17 mg/mL | Injection, SolutionSubcutaneous | Eli Lilly and Company | 0002-3466 |
| Mounjarotirzepatide | Tirzepatide 12.5 mg/.5mL | Injection, SolutionSubcutaneous | Eli Lilly and Company | 0002-1460 |
| Mounjarotirzepatide | Tirzepatide 8.33 mg/mL | Injection, SolutionSubcutaneous | Eli Lilly and Company | 0002-4103 |
| Mounjarotirzepatide | Tirzepatide 5 mg/.5mL | Injection, SolutionSubcutaneous | Eli Lilly and Company | 0002-1495 |
| Mounjarotirzepatide | Tirzepatide 25 mg/mL | Injection, SolutionSubcutaneous | Eli Lilly and Company | 0002-4612 |
| Mounjaro KwikPentirzepatide | Tirzepatide 25 mg/mL | Injection, SolutionSubcutaneous | Eli Lilly and Company | 0002-3411 |
| Mounjaro KwikPentirzepatide | Tirzepatide 12.5 mg/mL | Injection, SolutionSubcutaneous | Eli Lilly and Company | 0002-3444 |
| Mounjarotirzepatide | Tirzepatide 10 mg/.5mL | Injection, SolutionSubcutaneous | Eli Lilly and Company | 0002-1471 |
| Mounjarotirzepatide | Tirzepatide 12.5 mg/mL | Injection, SolutionSubcutaneous | Eli Lilly and Company | 0002-4210 |
| Mounjarotirzepatide | Tirzepatide 2.5 mg/.5mL | Injection, SolutionSubcutaneous | Eli Lilly and Company | 0002-1506 |
| Mounjarotirzepatide | Tirzepatide 7.5 mg/.5mL | Injection, SolutionSubcutaneous | Eli Lilly and Company | 0002-2214 |
| Mounjarotirzepatide | Tirzepatide 5 mg/.5mL | Injection, SolutionSubcutaneous | Eli Lilly and Company | 0002-1243 |
| Mounjarotirzepatide | Tirzepatide 15 mg/.5mL | Injection, SolutionSubcutaneous | Eli Lilly and Company | 0002-3002 |
| Mounjarotirzepatide | Tirzepatide 10 mg/.5mL | Injection, SolutionSubcutaneous | Eli Lilly and Company | 0002-2340 |
| Mounjaro KwikPentirzepatide | Tirzepatide 8.33 mg/mL | Injection, SolutionSubcutaneous | Eli Lilly and Company | 0002-3455 |
| Mounjarotirzepatide | Tirzepatide 4.17 mg/mL | Injection, SolutionSubcutaneous | Eli Lilly and Company | 0002-4052 |
| Mounjarotirzepatide | Tirzepatide 15 mg/.5mL | Injection, SolutionSubcutaneous | Eli Lilly and Company | 0002-1457 |
| Mounjarotirzepatide | Tirzepatide 7.5 mg/.5mL | Injection, SolutionSubcutaneous | Eli Lilly and Company | 0002-1484 |
| Mounjarotirzepatide | Tirzepatide 16.7 mg/mL | Injection, SolutionSubcutaneous | Eli Lilly and Company | 0002-4304 |
Showing 20 of 29.
- Source
- FDA NDC Directory via openFDA; FDA SPL via openFDA and DailyMed; Med-Code HCPCS directory (curated)
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.