NDC codes

FDA NDC Directory
Product NDC (as listed)0002-1460Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00002-1460Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0002-1460-80000021460804 SYRINGE in 1 CARTON (0002-1460-80) / .5 mL in 1 SYRINGE (0002-1460-01)Marketed from May 13, 2022

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
Generic name (nonproprietary)
tirzepatide
Active ingredients
Tirzepatide12.5 mg/.5mL
Dosage form
Injection, Solution
Route
Subcutaneous
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 0002-1460_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.

How CPT relates to drug billing

NDC on a medical claim

N400002146080 followed by a unit qualifier and the quantity

Package 00002-1460-80. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 215866

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 215866
ProductStrengthForm · routeLabelerProduct NDC
Mounjaro KwikPentirzepatideTirzepatide 16.7 mg/mLInjection, SolutionSubcutaneousEli Lilly and Company0002-3433
Mounjaro KwikPentirzepatideTirzepatide 4.17 mg/mLInjection, SolutionSubcutaneousEli Lilly and Company0002-3466
MounjarotirzepatideTirzepatide 8.33 mg/mLInjection, SolutionSubcutaneousEli Lilly and Company0002-4103
MounjarotirzepatideTirzepatide 5 mg/.5mLInjection, SolutionSubcutaneousEli Lilly and Company0002-1495
MounjarotirzepatideTirzepatide 25 mg/mLInjection, SolutionSubcutaneousEli Lilly and Company0002-4612
Mounjaro KwikPentirzepatideTirzepatide 25 mg/mLInjection, SolutionSubcutaneousEli Lilly and Company0002-3411
Mounjaro KwikPentirzepatideTirzepatide 12.5 mg/mLInjection, SolutionSubcutaneousEli Lilly and Company0002-3444
MounjarotirzepatideTirzepatide 10 mg/.5mLInjection, SolutionSubcutaneousEli Lilly and Company0002-1471
MounjarotirzepatideTirzepatide 12.5 mg/mLInjection, SolutionSubcutaneousEli Lilly and Company0002-4210
MounjarotirzepatideTirzepatide 2.5 mg/.5mLInjection, SolutionSubcutaneousEli Lilly and Company0002-1506
MounjarotirzepatideTirzepatide 7.5 mg/.5mLInjection, SolutionSubcutaneousEli Lilly and Company0002-2214
MounjarotirzepatideTirzepatide 5 mg/.5mLInjection, SolutionSubcutaneousEli Lilly and Company0002-1243
MounjarotirzepatideTirzepatide 15 mg/.5mLInjection, SolutionSubcutaneousEli Lilly and Company0002-3002
MounjarotirzepatideTirzepatide 10 mg/.5mLInjection, SolutionSubcutaneousEli Lilly and Company0002-2340
Mounjaro KwikPentirzepatideTirzepatide 20.8 mg/mLInjection, SolutionSubcutaneousEli Lilly and Company0002-3422
Mounjaro KwikPentirzepatideTirzepatide 8.33 mg/mLInjection, SolutionSubcutaneousEli Lilly and Company0002-3455
MounjarotirzepatideTirzepatide 4.17 mg/mLInjection, SolutionSubcutaneousEli Lilly and Company0002-4052
MounjarotirzepatideTirzepatide 15 mg/.5mLInjection, SolutionSubcutaneousEli Lilly and Company0002-1457
MounjarotirzepatideTirzepatide 7.5 mg/.5mLInjection, SolutionSubcutaneousEli Lilly and Company0002-1484
MounjarotirzepatideTirzepatide 16.7 mg/mLInjection, SolutionSubcutaneousEli Lilly and Company0002-4304

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