FDA.reportPublic FDA data

Mounjaro

Product NDC
0002-4103
11-digit product format
000024103
Labeler code
0002
Product ID
0002-4103_08af2d71-07e5-474b-98a2-eb5be9bcf894
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tirzepatide
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Eli Lilly and Company
Application
NDA215866
Marketing category
NDA
Marketing start
2026-01-07
Substance
TIRZEPATIDE
Active strength
8.33 mg/mL
Pharmacologic classes
G-Protein-linked Receptor Interactions [MoA], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Glucose-dependent Insulinotropic Polypeptide Receptor Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N215866-001MOUNJARO (AUTOINJECTOR)TIRZEPATIDE2.5MG/0.5ML (2.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-05-13
N215866-002MOUNJARO (AUTOINJECTOR)TIRZEPATIDE5MG/0.5ML (5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-05-13
N215866-003MOUNJARO (AUTOINJECTOR)TIRZEPATIDE7.5MG/0.5ML (7.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-05-13
N215866-004MOUNJARO (AUTOINJECTOR)TIRZEPATIDE10MG/0.5ML (10MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-05-13
N215866-005MOUNJARO (AUTOINJECTOR)TIRZEPATIDE12.5MG/0.5ML (12.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-05-13
N215866-006MOUNJARO (AUTOINJECTOR)TIRZEPATIDE15MG/0.5ML (15MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2022-05-13
N215866-007MOUNJAROTIRZEPATIDE2.5MG/0.5ML (2.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-07-28
N215866-008MOUNJAROTIRZEPATIDE5MG/0.5ML (5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-07-28
N215866-009MOUNJAROTIRZEPATIDE7.5MG/0.5ML (7.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-07-28
N215866-010MOUNJAROTIRZEPATIDE10MG/0.5ML (10MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-07-28
N215866-011MOUNJAROTIRZEPATIDE12.5MG/0.5ML (12.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-07-28
N215866-012MOUNJAROTIRZEPATIDE15MG/0.5ML (15MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-07-28
N215866-013MOUNJAROTIRZEPATIDE10MG/2.4ML (4.17MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-07
N215866-014MOUNJAROTIRZEPATIDE20MG/2.4ML (8.33MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-07
N215866-015MOUNJAROTIRZEPATIDE30MG/2.4ML (12.5MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-07
N215866-016MOUNJAROTIRZEPATIDE40MG/2.4ML (16.7MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-07
N215866-017MOUNJAROTIRZEPATIDE50MG/2.4ML (20.8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-07
N215866-018MOUNJAROTIRZEPATIDE60MG/2.4ML (25MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-07
N215866-019MOUNJARO KWIKPENTIRZEPATIDE10MG/2.4ML (4.17MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-20
N215866-020MOUNJARO KWIKPENTIRZEPATIDE20MG/2.4ML (8.33MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-20
N215866-021MOUNJARO KWIKPENTIRZEPATIDE30MG/2.4ML (12.5MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-20
N215866-022MOUNJARO KWIKPENTIRZEPATIDE40MG/2.4ML (16.7MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-20
N215866-023MOUNJARO KWIKPENTIRZEPATIDE50MG/2.4ML (20.8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-20
N215866-024MOUNJARO KWIKPENTIRZEPATIDE60MG/2.4ML (25MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-20

Orange Book patents#

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N215866-00194747802036-01-05U-4374Drug substance, Drug product2022-06-09
N215866-001113578202039-06-14Drug product2022-06-30
N215866-001124537552039-06-14U-43752025-11-17
N215866-001124537552039-06-14U-43762025-11-17
N215866-001124537552039-06-14U-43772025-11-17
N215866-001124537552039-06-14U-43782025-11-17
N215866-001124537552039-06-14U-43792025-11-17
N215866-001124537552039-06-14U-43802025-11-17
N215866-001124537552039-06-14U-43812025-11-17
N215866-001124537552039-06-14U-43822025-11-17
N215866-001124537552039-06-14U-43832025-11-17
N215866-001124537552039-06-14U-43842025-11-17
N215866-001124537552039-06-14U-43852025-11-17
N215866-001124537552039-06-14U-43862025-11-17
N215866-001124537562039-06-14Drug product2025-11-17
N215866-001126294042039-06-14U-4533Drug product2026-06-05
N215866-001126294042039-06-14U-4534Drug product2026-06-05
N215866-001123433822039-07-22U-44012025-07-25
N215866-001123433822039-07-22U-42292025-07-25
N215866-001123433822039-07-22U-42302025-07-25
N215866-001123433822039-07-22U-42312025-07-25
N215866-001123433822039-07-22U-42322025-07-25
N215866-001123433822039-07-22U-44002025-07-25
N215866-001126167402039-07-22U-45002026-05-05
N215866-001126167402039-07-22U-45012026-05-05
N215866-001126167402039-07-22U-45022026-05-05
N215866-001122959872041-12-30U-41922025-06-11
N215866-001122959872041-12-30U-41932025-06-11
N215866-00294747802036-01-05U-4374Drug substance, Drug product2022-06-09
N215866-002113578202039-06-14Drug product2022-06-30
N215866-002124537552039-06-14U-43782025-11-17
N215866-002124537552039-06-14U-43862025-11-17
N215866-002124537552039-06-14U-43852025-11-17
N215866-002124537552039-06-14U-43842025-11-17
N215866-002124537552039-06-14U-43812025-11-17
N215866-002124537552039-06-14U-43772025-11-17
N215866-002124537552039-06-14U-43802025-11-17
N215866-002124537552039-06-14U-43752025-11-17
N215866-002124537552039-06-14U-43792025-11-17
N215866-002124537552039-06-14U-43832025-11-17
N215866-002124537552039-06-14U-43762025-11-17
N215866-002124537552039-06-14U-43822025-11-17
N215866-002124537562039-06-14Drug product2025-11-17
N215866-002126294042039-06-14U-4534Drug product2026-06-05
N215866-002126294042039-06-14U-4533Drug product2026-06-05
N215866-002123433822039-07-22U-42292025-07-25
N215866-002123433822039-07-22U-42302025-07-25
N215866-002123433822039-07-22U-42312025-07-25
N215866-002123433822039-07-22U-42322025-07-25
N215866-002123433822039-07-22U-44012025-07-25
N215866-002123433822039-07-22U-44002025-07-25
N215866-002126167402039-07-22U-45012026-05-05
N215866-002126167402039-07-22U-45022026-05-05
N215866-002126167402039-07-22U-45002026-05-05
N215866-002122959872041-12-30U-41932025-06-11
N215866-002122959872041-12-30U-41922025-06-11
N215866-00394747802036-01-05U-4374Drug substance, Drug product2022-06-09
N215866-003113578202039-06-14Drug product2022-06-30
N215866-003124537552039-06-14U-43832025-11-17
N215866-003124537552039-06-14U-43862025-11-17
N215866-003124537552039-06-14U-43812025-11-17
N215866-003124537552039-06-14U-43772025-11-17
N215866-003124537552039-06-14U-43852025-11-17
N215866-003124537552039-06-14U-43802025-11-17
N215866-003124537552039-06-14U-43782025-11-17
N215866-003124537552039-06-14U-43762025-11-17
N215866-003124537552039-06-14U-43822025-11-17
N215866-003124537552039-06-14U-43792025-11-17
N215866-003124537552039-06-14U-43752025-11-17
N215866-003124537552039-06-14U-43842025-11-17
N215866-003124537562039-06-14Drug product2025-11-17
N215866-003126294042039-06-14U-4533Drug product2026-06-05
N215866-003126294042039-06-14U-4534Drug product2026-06-05
N215866-003123433822039-07-22U-44002025-07-25
N215866-003123433822039-07-22U-42292025-07-25
N215866-003123433822039-07-22U-42302025-07-25
N215866-003123433822039-07-22U-42312025-07-25
N215866-003123433822039-07-22U-42322025-07-25
N215866-003123433822039-07-22U-44012025-07-25
N215866-003126167402039-07-22U-45012026-05-05

Orange Book exclusivity#

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N215866-001NCE2027-05-13
N215866-001NPP2028-12-19
N215866-002NCE2027-05-13
N215866-002NPP2028-12-19
N215866-003NCE2027-05-13
N215866-003NPP2028-12-19
N215866-004NCE2027-05-13
N215866-004NPP2028-12-19
N215866-005NCE2027-05-13
N215866-006NCE2027-05-13
N215866-007NCE2027-05-13
N215866-007NPP2028-12-19
N215866-008NCE2027-05-13
N215866-008NPP2028-12-19
N215866-009NCE2027-05-13
N215866-009NPP2028-12-19
N215866-010NCE2027-05-13
N215866-010NPP2028-12-19
N215866-011NCE2027-05-13
N215866-012NCE2027-05-13
N215866-013NCE2027-05-13
N215866-013NPP2028-12-19
N215866-014NCE2027-05-13
N215866-014NPP2028-12-19
N215866-015NCE2027-05-13
N215866-015NPP2028-12-19
N215866-016NCE2027-05-13
N215866-016NPP2028-12-19
N215866-017NCE2027-05-13
N215866-017NPP2028-12-19
N215866-018NCE2027-05-13
N215866-018NPP2028-12-19
N215866-019NCE2027-05-13
N215866-019NPP2028-12-19
N215866-020NCE2027-05-13
N215866-020NPP2028-12-19
N215866-021NCE2027-05-13
N215866-021NPP2028-12-19
N215866-022NCE2027-05-13
N215866-022NPP2028-12-19
N215866-023NCE2027-05-13
N215866-024NCE2027-05-13

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MounjaroTIRZEPATIDEEli Lilly and Companyd2d7da5d-ad07-4228-955f-cf7e355c8cc02026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier

Boxed warning cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

boxed warning

WARNING: RISK OF THYROID C-CELL TUMORS In both male and female 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 as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ) and Nonclinical Toxicology ( 13.1 )]. 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) [see Contraindications ( 4 )] . Counsel patients regarding the potential risk for MTC with the use of MOUNJARO and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with MOUNJARO [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. Tirzepatide causes thyroid C-cell tumors in rats. It is unknown whether MOUNJARO causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined ( 5.1 , 13.1 ). 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). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors ( 4 , 5.1 ).

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings and cautions

5 WARNINGS AND PRECAUTIONS Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, or MOUNJARO. Discontinue if pancreatitis is suspected. ( 5.2 ) Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing dose of insulin secretagogue or insulin may be necessary. ( 5.3 ) Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue MOUNJARO if suspected and promptly seek medical advice. ( 5.4 ) Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. ( 5.5 ) Severe Gastrointestinal Adverse Reactions: Use has been associated with gastrointestinal adverse reactions, sometimes severe. MOUNJARO is not recommended in patients with severe gastroparesis. ( 5.6 ) Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy: Has not been studied in patients with non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema. Monitor patients with a history of diabetic retinopathy for progression. ( 5.7 ) Acute Gallbladder Disease: Has occurred in clinical trials. If cholelithiasis is suspected, gallbladder studies and clinical follow-up are indicated. ( 5.8 ) Pulmonary Aspiration During General Anesthesia or Deep Sedation: Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures. Instruct patients to inform healthcare providers of any planned surgeries or procedures. ( 5.9 ) Never share a MOUNJARO KwikPen between patients, even if the pen needle is changed. ( 5.10 ) 5.1 Risk of Thyroid C-Cell Tumors In both sexes of rats, tirzepatide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) in a 2-year study at clinically relevant plasma exposures [see Nonclinical Toxicology ( 13.1 )] . It is unknown whether MOUNJARO causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined. MOUNJARO is contraindicated in ...

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

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-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in the Clinical Trials of Adults with Type 2 Diabetes Mellitus Pool of Two Placebo-Controlled Clinical Trials in Adults The data in Table 1 are derived from 2 placebo-controlled trials [1 monotherapy trial (SURPASS-1) and 1 trial in combination with basal insulin with or without metformin (SURPASS-5)] in adult patients with type 2 diabetes mellitus [see Clinical Studies ( 14.2 , 14.4 )] . These data reflect exposure of 718 patients to MOUNJARO and a mean duration of exposure to MOUNJARO of 36.6 weeks. The mean age of patients was 58 years, 4% were 75 years or older and 54% were male. The population was 57% White, 27% Asian, 13% American Indian or Alaska Native, and 3% Black or African American; 25% identified as Hispanic or Latino ethnicity. At baseline, patients had type 2 diabetes mellitus for an average of 9.1 years with a mean HbA1c of 8.1%....

adverse reactions table

Table 1: Adverse Reactions in Pool of Placebo-Controlled Trials Reported in ≥5% of MOUNJARO-treated Adult Patients with Type 2 Diabetes Mellitus Note: Percentages reflect the number of patients who reported at least 1 occurrence of the adverse reaction. Adverse ReactionPlacebo (N=235) %MOUNJARO 5 mg (N=237) %MOUNJARO 10 mg (N=240) %MOUNJARO 15 mg (N=241) %Nausea 4 12 15 18 Diarrhea 9 12 13 17 Decreased Appetite 1 5 10 11 Vomiting 2 5 5 9 Constipation 1 6 6 7 Dyspepsia 3 8 8 5 Abdominal Pain 4 6 5 5

Additional Listing Data#

Finished product
Yes
Brand name base
Mounjaro
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIRZEPATIDE8.33 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOYN3CCI6QE
Rxcui2601743, 2601746, 2601755, 2601758, 2601761, 2601764, 2601767, 2601770, 2601773, 2601776, 2601784, 2601785, 2644396, 2644399, 2644401, 2644403, 2644405, 2644407, 2644409, 2644411

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
764832a6-c731-479b-b340-b4c8813a2a29Product name120250724
079c774f-6797-40bd-b11b-fd311f893a4eProduct name120230124

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-4103-01Mounjaro2.4 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION2.438
0002-4103-11Mounjaro1 in 1 CARTONINJECTION, SOLUTION138

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2601770mounjaro 10 MG in 0.5 ML Auto-InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2644419mounjaro 10 MG in 0.5 ML InjectionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2735292mounjaro 10 MG per dose (40 MG in 2.4 ML) Pen InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2601776mounjaro 12.5 MG in 0.5 ML Auto-InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2644415mounjaro 12.5 MG in 0.5 ML InjectionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2735294mounjaro 12.5 MG per dose (50 MG in 2.4 ML) Pen InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2733666mounjaro 12.5 MG/ML Injectable SolutionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2601758mounjaro 15 MG in 0.5 ML Auto-InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2644411mounjaro 15 MG in 0.5 ML InjectionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2735297mounjaro 15 MG per dose (60 MG in 2.4 ML) Pen InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2733668mounjaro 16.7 MG/ML Injectable SolutionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2601764mounjaro 2.5 MG in 0.5 ML Auto-InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2644407mounjaro 2.5 MG in 0.5 ML InjectionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2735286mounjaro 2.5 MG per dose (10 MG in 2.4 ML) Pen InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2733670mounjaro 20.8 MG/ML Injectable SolutionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2733671mounjaro 25 MG/ML Injectable SolutionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2733673mounjaro 4.17 MG/ML Injectable SolutionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2601746mounjaro 5 MG in 0.5 ML Auto-InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2644403mounjaro 5 MG in 0.5 ML InjectionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2735288mounjaro 5 MG per dose (20 MG in 2.4 ML) Pen InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2601785mounjaro 7.5 MG in 0.5 ML Auto-InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2644399mounjaro 7.5 MG in 0.5 ML InjectionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2735290mounjaro 7.5 MG per dose (30 MG in 2.4 ML) Pen InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2733675mounjaro 8.33 MG/ML Injectable SolutionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2601767tirzepatide 10 MG in 0.5 ML Auto-InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2644417tirzepatide 10 MG in 0.5 ML InjectionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2734628tirzepatide 10 MG per dose (40 MG in 2.4 ML) Pen InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2601773tirzepatide 12.5 MG in 0.5 ML Auto-InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2644413tirzepatide 12.5 MG in 0.5 ML InjectionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2734632tirzepatide 12.5 MG per dose (50 MG in 2.4 ML) Pen InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2732437tirzepatide 12.5 MG/ML Injectable SolutionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2601755tirzepatide 15 MG in 0.5 ML Auto-InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2644409tirzepatide 15 MG in 0.5 ML InjectionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2734636tirzepatide 15 MG per dose (60 MG in 2.4 ML) Pen InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2732442tirzepatide 16.7 MG/ML Injectable SolutionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2601761tirzepatide 2.5 MG in 0.5 ML Auto-InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2644405tirzepatide 2.5 MG in 0.5 ML InjectionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2734640tirzepatide 2.5 MG per dose (10 MG in 2.4 ML) Pen InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2732446tirzepatide 20.8 MG/ML Injectable SolutionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2732449tirzepatide 25 MG/ML Injectable SolutionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2732452tirzepatide 4.17 MG/ML Injectable SolutionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2601743tirzepatide 5 MG in 0.5 ML Auto-InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2644401tirzepatide 5 MG in 0.5 ML InjectionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2734644tirzepatide 5 MG per dose (20 MG in 2.4 ML) Pen InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2601784tirzepatide 7.5 MG in 0.5 ML Auto-InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2644396tirzepatide 7.5 MG in 0.5 ML InjectionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2734623tirzepatide 7.5 MG per dose (30 MG in 2.4 ML) Pen InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2732456tirzepatide 8.33 MG/ML Injectable SolutionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26017460.5 ML tirzepatide 10 MG/ML Auto-Injector [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26444030.5 ML tirzepatide 10 MG/ML Injection [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26017850.5 ML tirzepatide 15 MG/ML Auto-Injector [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26443990.5 ML tirzepatide 15 MG/ML Injection [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26017700.5 ML tirzepatide 20 MG/ML Auto-Injector [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26444190.5 ML tirzepatide 20 MG/ML Injection [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26017760.5 ML tirzepatide 25 MG/ML Auto-Injector [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26444150.5 ML tirzepatide 25 MG/ML Injection [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26017580.5 ML tirzepatide 30 MG/ML Auto-Injector [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26444110.5 ML tirzepatide 30 MG/ML Injection [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26017640.5 ML tirzepatide 5 MG/ML Auto-Injector [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26444070.5 ML tirzepatide 5 MG/ML Injection [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
27352902.4 ML tirzepatide 12.5 MG/ML Pen Injector [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
27352922.4 ML tirzepatide 16.7 MG/ML Pen Injector [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
27352942.4 ML tirzepatide 20.8 MG/ML Pen Injector [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
27352972.4 ML tirzepatide 25 MG/ML Pen Injector [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
27352862.4 ML tirzepatide 4.17 MG/ML Pen Injector [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
27352882.4 ML tirzepatide 8.33 MG/ML Pen Injector [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2733666tirzepatide 12.5 MG/ML Injectable Solution [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2733668tirzepatide 16.7 MG/ML Injectable Solution [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2733670tirzepatide 20.8 MG/ML Injectable Solution [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2733671tirzepatide 25 MG/ML Injectable Solution [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2733673tirzepatide 4.17 MG/ML Injectable Solution [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2733675tirzepatide 8.33 MG/ML Injectable Solution [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26017430.5 ML tirzepatide 10 MG/ML Auto-InjectorSCDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26444010.5 ML tirzepatide 10 MG/ML InjectionSCDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26017840.5 ML tirzepatide 15 MG/ML Auto-InjectorSCDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26443960.5 ML tirzepatide 15 MG/ML InjectionSCDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26017670.5 ML tirzepatide 20 MG/ML Auto-InjectorSCDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26444170.5 ML tirzepatide 20 MG/ML InjectionSCDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26017730.5 ML tirzepatide 25 MG/ML Auto-InjectorSCDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26444130.5 ML tirzepatide 25 MG/ML InjectionSCDd2d7da5d-ad07-4228-955f-cf7e355c8cc038

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0002-4103-01000024103012.4 mL in 1 VIAL, MULTI-DOSE2.4 mlHistorical
0002-4103-11000024103111 VIAL, MULTI-DOSE in 1 CARTON (0002-4103-11) / 2.4 mL in 1 VIAL, MULTI-DOSE (0002-4103-01) 2026-01-07NoNoCurrent