FDA.reportPublic FDA data

Zepbound

Product NDC
0002-2002
11-digit product format
000022002
Labeler code
0002
Product ID
0002-2002_86a64015-7f78-4281-8b7f-579b6c3dc1f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tirzepatide
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Eli Lilly and Company
Application
NDA217806
Marketing category
NDA
Marketing start
2024-03-28
Substance
TIRZEPATIDE
Active strength
15 mg/.5mL
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
N217806-001ZEPBOUND (AUTOINJECTOR)TIRZEPATIDE2.5MG/0.5ML (2.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-11-08
N217806-002ZEPBOUND (AUTOINJECTOR)TIRZEPATIDE5MG/0.5ML (5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-11-08
N217806-003ZEPBOUND (AUTOINJECTOR)TIRZEPATIDE7.5MG/0.5ML (7.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-11-08
N217806-004ZEPBOUND (AUTOINJECTOR)TIRZEPATIDE10MG/0.5ML (10MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-11-08
N217806-005ZEPBOUND (AUTOINJECTOR)TIRZEPATIDE12.5MG/0.5ML (12.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-11-08
N217806-006ZEPBOUND (AUTOINJECTOR)TIRZEPATIDE15MG/0.5ML (15MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-11-08
N217806-007ZEPBOUNDTIRZEPATIDE2.5MG/0.5ML (2.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-03-28
N217806-008ZEPBOUNDTIRZEPATIDE5MG/0.5ML (5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-03-28
N217806-009ZEPBOUNDTIRZEPATIDE7.5MG/0.5ML (7.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-03-28
N217806-010ZEPBOUNDTIRZEPATIDE10MG/0.5ML (10MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-03-28
N217806-011ZEPBOUNDTIRZEPATIDE12.5MG/0.5ML (12.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-03-28
N217806-012ZEPBOUNDTIRZEPATIDE15MG/0.5ML (15MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-03-28
N217806-013ZEPBOUNDTIRZEPATIDE10MG/2.4ML (4.17MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-07
N217806-014ZEPBOUNDTIRZEPATIDE20MG/2.4ML (8.33MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-07
N217806-015ZEPBOUNDTIRZEPATIDE30MG/2.4ML (12.5MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-07
N217806-016ZEPBOUNDTIRZEPATIDE40MG/2.4ML (16.7MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-07
N217806-017ZEPBOUNDTIRZEPATIDE50MG/2.4ML (20.8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-07
N217806-018ZEPBOUNDTIRZEPATIDE60MG/2.4ML (25MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-07
N217806-019ZEPBOUND KWIKPENTIRZEPATIDE10MG/2.4ML (4.17MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-20
N217806-020ZEPBOUND KWIKPENTIRZEPATIDE20MG/2.4ML (8.33MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-20
N217806-021ZEPBOUND KWIKPENTIRZEPATIDE30MG/2.4ML (12.5MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-20
N217806-022ZEPBOUND KWIKPENTIRZEPATIDE40MG/2.4ML (16.7MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-20
N217806-023ZEPBOUND KWIKPENTIRZEPATIDE50MG/2.4ML (20.8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-20
N217806-024ZEPBOUND KWIKPENTIRZEPATIDE60MG/2.4ML (25MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-20

Orange Book patents#

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217806-00194747802036-01-05Drug substance, Drug product2023-12-07
N217806-001113578202039-06-14Drug product2023-12-07
N217806-001119186232039-06-14U-38552024-03-28
N217806-001124537562039-06-14Drug product2025-11-17
N217806-001126294042039-06-14U-4532Drug product2026-06-05
N217806-001126294042039-06-14U-4531Drug product2026-06-05
N217806-001123433822039-07-22U-42272025-07-25
N217806-001123433822039-07-22U-42282025-07-25
N217806-001123433822039-07-22U-44102025-07-25
N217806-001123433822039-07-22U-44092025-07-25
N217806-001124537582039-07-22U-43102025-11-17
N217806-001124537582039-07-22U-43112025-11-17
N217806-001124537582039-07-22U-43082025-11-17
N217806-001124537582039-07-22U-43092025-11-17
N217806-001126167402039-07-22U-44972026-05-05
N217806-001126167402039-07-22U-44982026-05-05
N217806-001126167402039-07-22U-44992026-05-05
N217806-00294747802036-01-05Drug substance, Drug product2023-12-07
N217806-002113578202039-06-14Drug product2023-12-07
N217806-002119186232039-06-14U-38552024-03-28
N217806-002124537562039-06-14Drug product2025-11-17
N217806-002126294042039-06-14U-4531Drug product2026-06-05
N217806-002126294042039-06-14U-4532Drug product2026-06-05
N217806-002123433822039-07-22U-44092025-07-25
N217806-002123433822039-07-22U-44102025-07-25
N217806-002123433822039-07-22U-42272025-07-25
N217806-002123433822039-07-22U-42282025-07-25
N217806-002124537582039-07-22U-43112025-11-17
N217806-002124537582039-07-22U-43082025-11-17
N217806-002124537582039-07-22U-43092025-11-17
N217806-002124537582039-07-22U-43102025-11-17
N217806-002126167402039-07-22U-44982026-05-05
N217806-002126167402039-07-22U-44972026-05-05
N217806-002126167402039-07-22U-44992026-05-05
N217806-00394747802036-01-05Drug substance, Drug product2023-12-07
N217806-003113578202039-06-14Drug product2023-12-07
N217806-003119186232039-06-14U-38552024-03-28
N217806-003124537562039-06-14Drug product2025-11-17
N217806-003126294042039-06-14U-4532Drug product2026-06-05
N217806-003126294042039-06-14U-4531Drug product2026-06-05
N217806-003123433822039-07-22U-44102025-07-25
N217806-003123433822039-07-22U-44092025-07-25
N217806-003123433822039-07-22U-42272025-07-25
N217806-003123433822039-07-22U-42282025-07-25
N217806-003124537582039-07-22U-43102025-11-17
N217806-003124537582039-07-22U-43082025-11-17
N217806-003124537582039-07-22U-43092025-11-17
N217806-003124537582039-07-22U-43112025-11-17
N217806-003126167402039-07-22U-44982026-05-05
N217806-003126167402039-07-22U-44972026-05-05
N217806-003126167402039-07-22U-44992026-05-05
N217806-00494747802036-01-05Drug substance, Drug product2023-12-07
N217806-004113578202039-06-14Drug product2023-12-07
N217806-004119186232039-06-14U-38552024-03-28
N217806-004124537562039-06-14Drug product2025-11-17
N217806-004126294042039-06-14U-4531Drug product2026-06-05
N217806-004126294042039-06-14U-4532Drug product2026-06-05
N217806-004123433822039-07-22U-42282025-07-25
N217806-004123433822039-07-22U-42272025-07-25
N217806-004123433822039-07-22U-44092025-07-25
N217806-004123433822039-07-22U-44102025-07-25
N217806-004124537582039-07-22U-43092025-11-17
N217806-004124537582039-07-22U-43102025-11-17
N217806-004124537582039-07-22U-43112025-11-17
N217806-004124537582039-07-22U-43082025-11-17
N217806-004126167402039-07-22U-44992026-05-05
N217806-004126167402039-07-22U-44982026-05-05
N217806-004126167402039-07-22U-44972026-05-05
N217806-00594747802036-01-05Drug substance, Drug product2023-12-07
N217806-005113578202039-06-14Drug product2023-12-07
N217806-005119186232039-06-14U-38552024-03-28
N217806-005124537562039-06-14Drug product2025-11-17
N217806-005126294042039-06-14U-4531Drug product2026-06-05
N217806-005126294042039-06-14U-4532Drug product2026-06-05
N217806-005123433822039-07-22U-44102025-07-25
N217806-005123433822039-07-22U-44092025-07-25
N217806-005123433822039-07-22U-42272025-07-25
N217806-005123433822039-07-22U-42282025-07-25
N217806-005124537582039-07-22U-43102025-11-17
N217806-005124537582039-07-22U-43112025-11-17

Orange Book exclusivity#

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N217806-001NP2026-11-08
N217806-001NCE2027-05-13
N217806-001M-822027-10-18
N217806-001I-9582027-12-20
N217806-002NP2026-11-08
N217806-002NCE2027-05-13
N217806-002M-822027-10-18
N217806-002I-9582027-12-20
N217806-003NP2026-11-08
N217806-003NCE2027-05-13
N217806-003M-822027-10-18
N217806-003I-9582027-12-20
N217806-004NP2026-11-08
N217806-004NCE2027-05-13
N217806-004M-822027-10-18
N217806-004I-9582027-12-20
N217806-005NP2026-11-08
N217806-005NCE2027-05-13
N217806-005M-822027-10-18
N217806-005I-9582027-12-20
N217806-006NP2026-11-08
N217806-006NCE2027-05-13
N217806-006M-822027-10-18
N217806-006I-9582027-12-20
N217806-007NCE2027-05-13
N217806-007M-822027-10-18
N217806-007I-9582027-12-20
N217806-008NCE2027-05-13
N217806-008M-822027-10-18
N217806-008I-9582027-12-20
N217806-009NCE2027-05-13
N217806-009M-822027-10-18
N217806-009I-9582027-12-20
N217806-010NCE2027-05-13
N217806-010M-822027-10-18
N217806-010I-9582027-12-20
N217806-011NCE2027-05-13
N217806-011M-822027-10-18
N217806-011I-9582027-12-20
N217806-012NCE2027-05-13
N217806-012M-822027-10-18
N217806-012I-9582027-12-20
N217806-013NCE2027-05-13
N217806-013M-822027-10-18
N217806-013I-9582027-12-20
N217806-014NCE2027-05-13
N217806-014M-822027-10-18
N217806-014I-9582027-12-20
N217806-015NCE2027-05-13
N217806-015M-822027-10-18
N217806-015I-9582027-12-20
N217806-016NCE2027-05-13
N217806-016M-822027-10-18
N217806-016I-9582027-12-20
N217806-017NCE2027-05-13
N217806-017M-822027-10-18
N217806-017I-9582027-12-20
N217806-018NCE2027-05-13
N217806-018M-822027-10-18
N217806-018I-9582027-12-20
N217806-019NCE2027-05-13
N217806-019M-822027-10-18
N217806-019I-9582027-12-20
N217806-020NCE2027-05-13
N217806-020M-822027-10-18
N217806-020I-9582027-12-20
N217806-021NCE2027-05-13
N217806-021M-822027-10-18
N217806-021I-9582027-12-20
N217806-022NCE2027-05-13
N217806-022M-822027-10-18
N217806-022I-9582027-12-20
N217806-023NCE2027-05-13
N217806-023M-822027-10-18
N217806-023I-9582027-12-20
N217806-024NCE2027-05-13
N217806-024M-822027-10-18
N217806-024I-9582027-12-20

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
ZepboundTIRZEPATIDEEli Lilly and Company487cd7e7-434c-4925-99fa-aa80b1cc776b2026-04-22Boxed 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 rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether ZEPBOUND 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 )]. ZEPBOUND 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 ZEPBOUND 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 ZEPBOUND [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. In rats, tirzepatide causes thyroid C-cell tumors. It is unknown whether ZEPBOUND 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 ). ZEPBOUND 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 Severe Gastrointestinal Adverse Reactions: Use has been associated with gastrointestinal adverse reactions, sometimes severe. ZEPBOUND is not recommended in patients with severe gastroparesis. ( 5.2 ) Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. ( 5.3 ) Acute Gallbladder Disease: Has been reported in clinical trials. If cholecystitis is suspected, gallbladder studies and clinical follow-up are indicated. ( 5.4 ) Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, or ZEPBOUND. Discontinue if pancreatitis is suspected. ( 5.5 ) Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported postmarketing with tirzepatide. If suspected, advise patients to promptly seek medical attention and discontinue ZEPBOUND. ( 5.6 ) Hypoglycemia: Concomitant use with insulin or an insulin secretagogue may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing dose of insulin or insulin secretagogue may be necessary. Inform all patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. ( 5.7 ) Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus: 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. ( 5.8 ) 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 ZEPBOUND KwikPen between patients, even if the pen needle is changed. ( 5.10 ) 5.1 Risk of Thyroid C-Cell Tumors In 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 ZEPBOUND causes thyroid C-cell tumors, including MTC, in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has...

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 )] Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.2 )] Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.3 )] Acute Gallbladder Disease [see Warnings and Precautions ( 5.4 )] Acute Pancreatitis [see Warnings and Precautions ( 5.5 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.6 )] Hypoglycemia [see Warnings and Precautions ( 5.7 )] Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus [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 ZEPBOUND are: nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection site reactions, fatigue, hypersensitivity reactions, eructation, hair loss, gastroesophageal reflux disease. ( 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 Patients for Weight Reduction and Long-Term Maintenance Pool of Placebo - Controlled Weight Reduction Trials in Adults with Obesity or Overweight, with or without Type 2 Diabetes (Study 1 and Study 2) ZEPBOUND was evaluated for safety in a pool of two randomized, double-blind, placebo-controlled trials that included 2,519 adult patients with obesity or overweight treated with ZEPBOUND for up to 72 weeks and a 4-week off drug follow-up period (Study 1 and Study 2) [see Clinical Studies ( 14.1 )] . The mean age of patients was 47 years and 37% were male. The population was 72% White, 12% Asian, 8% Black or African American, and 7% American Indian or Alaska Native; 51% identified as Hispanic or Latino ethnicity. Baseline characteristics included an average BMI of 37.4 kg/m 2 , 29% with a BMI ≥40 kg/m 2 , 41% with hy...

adverse reactions table

Table 1: Adverse Reactions (≥2% and Greater than Placebo) in ZEPBOUND-Treated Adults with Obesity or Overweight in Weight Reduction and Long-term Maintenance Trials (Study 1 and Study 2) a Includes diarrhea, frequent bowel movements. b Includes constipation, feces hard. c Includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness. d Includes multiple related adverse event terms, such as injection site bruising, injection site erythema, injection site pruritus, injection site pain, injection site rash, injection site reaction. e Includes asthenia, fatigue, lethargy, malaise. f Includes blood pressure decreased, hypotension, orthostatic hypotension. Adverse Reaction Placebo (N=958) %ZEPBOUND 5 mg (N=630) %ZEPBOUND 10 mg (N=948) %ZEPBOUND 15 mg (N=941) %Nausea 8 25 29 28 Diarrheaa8 19 21 23 Vomiting 2 8 11 13 Constipationb5 17 14 11 Abdominal Painc5 9 9 10 Dyspepsia 4 9 9 10 Injection Site Reactionsd2 6 8 8 Fatiguee3 5 6 7 Hypersensitivity Reactions 3 5 5 5 Eructation 1 4 5 5 Hair Loss 1 5 4 5 Gastroesophageal Reflux Disease 2 4 4 5 Flatulence 2 3 3 4 Abdominal Distension 2 3 3 4 Dizziness 2 4 5 4 Hypotensionf0 1 1 2

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIRZEPATIDE15 mg/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOYN3CCI6QE
Rxcui2601743, 2601755, 2601761, 2601767, 2601773, 2601784, 2644396, 2644401, 2644405, 2644409, 2644413, 2644417, 2669706, 2669709, 2669712, 2669715, 2669718, 2669721, 2679317, 2679319

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
764832a6-c731-479b-b340-b4c8813a2a29Product name120250724
079c774f-6797-40bd-b11b-fd311f893a4eProduct name120230124
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-2002-01Zepbound1 in 1 CARTONINJECTION, SOLUTION138
0002-2002-01Zepbound0.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION0.538
0002-2002-04Zepbound0.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION0.538
0002-2002-04Zepbound4 in 1 CARTONINJECTION, SOLUTION438

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-2002-01ML - Milliliter0002-2002301b68ff-0c3a-4bab-b778-c9ebcb180bbc12025-07-08
0002-2002-04ML - Milliliter0002-20024ad1b969-95b1-4589-b0f9-659915b5b90c12025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-2002ZEPBOUND (TIRZEPATIDE) INJECTION, SOLUTION ZEPBOUND (TIRZEPATIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY]22Current NDC, 4 package rows20250529_487cd7e7-434c-4925-99fa-aa80b1cc776b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2601767tirzepatide 10 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2644417tirzepatide 10 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734628tirzepatide 10 MG per dose (40 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2601773tirzepatide 12.5 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2644413tirzepatide 12.5 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734632tirzepatide 12.5 MG per dose (50 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732437tirzepatide 12.5 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2601755tirzepatide 15 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2644409tirzepatide 15 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734636tirzepatide 15 MG per dose (60 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732442tirzepatide 16.7 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2601761tirzepatide 2.5 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2644405tirzepatide 2.5 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734640tirzepatide 2.5 MG per dose (10 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732446tirzepatide 20.8 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732449tirzepatide 25 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732452tirzepatide 4.17 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2601743tirzepatide 5 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2644401tirzepatide 5 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734644tirzepatide 5 MG per dose (20 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2601784tirzepatide 7.5 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2644396tirzepatide 7.5 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734623tirzepatide 7.5 MG per dose (30 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732456tirzepatide 8.33 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2669715zepbound 10 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2679317zepbound 10 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734630zepbound 10 MG per dose (40 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2669718zepbound 12.5 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2679319zepbound 12.5 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734634zepbound 12.5 MG per dose (50 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732440zepbound 12.5 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2669721zepbound 15 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2679321zepbound 15 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734638zepbound 15 MG per dose (60 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732444zepbound 16.7 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2669706zepbound 2.5 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2679323zepbound 2.5 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734642zepbound 2.5 MG per dose (10 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732448zepbound 20.8 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732450zepbound 25 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732454zepbound 4.17 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2669709zepbound 5 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2679325zepbound 5 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734646Zepbound 5 MG per dose (20 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2669712zepbound 7.5 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2679327zepbound 7.5 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734626zepbound 7.5 MG per dose (30 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732458zepbound 8.33 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
26697090.5 ML tirzepatide 10 MG/ML Auto-Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26793250.5 ML tirzepatide 10 MG/ML Injection [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26697120.5 ML tirzepatide 15 MG/ML Auto-Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26793270.5 ML tirzepatide 15 MG/ML Injection [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26697150.5 ML tirzepatide 20 MG/ML Auto-Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26793170.5 ML tirzepatide 20 MG/ML Injection [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26697180.5 ML tirzepatide 25 MG/ML Auto-Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26793190.5 ML tirzepatide 25 MG/ML Injection [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26697210.5 ML tirzepatide 30 MG/ML Auto-Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26793210.5 ML tirzepatide 30 MG/ML Injection [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26697060.5 ML tirzepatide 5 MG/ML Auto-Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26793230.5 ML tirzepatide 5 MG/ML Injection [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
27346262.4 ML tirzepatide 12.5 MG/ML Pen Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
27346302.4 ML tirzepatide 16.7 MG/ML Pen Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
27346342.4 ML tirzepatide 20.8 MG/ML Pen Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
27346382.4 ML tirzepatide 25 MG/ML Pen Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
27346422.4 ML tirzepatide 4.17 MG/ML Pen Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
27346462.4 ML tirzepatide 8.33 MG/ML Pen Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732440tirzepatide 12.5 MG/ML Injectable Solution [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732444tirzepatide 16.7 MG/ML Injectable Solution [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732448tirzepatide 20.8 MG/ML Injectable Solution [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732450tirzepatide 25 MG/ML Injectable Solution [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732454tirzepatide 4.17 MG/ML Injectable Solution [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732458tirzepatide 8.33 MG/ML Injectable Solution [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26017430.5 ML tirzepatide 10 MG/ML Auto-InjectorSCD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26444010.5 ML tirzepatide 10 MG/ML InjectionSCD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26017840.5 ML tirzepatide 15 MG/ML Auto-InjectorSCD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26443960.5 ML tirzepatide 15 MG/ML InjectionSCD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26017670.5 ML tirzepatide 20 MG/ML Auto-InjectorSCD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26444170.5 ML tirzepatide 20 MG/ML InjectionSCD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26017730.5 ML tirzepatide 25 MG/ML Auto-InjectorSCD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26444130.5 ML tirzepatide 25 MG/ML InjectionSCD487cd7e7-434c-4925-99fa-aa80b1cc776b38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0002-2002-01000022002011 VIAL, SINGLE-DOSE in 1 CARTON (0002-2002-01) / .5 mL in 1 VIAL, SINGLE-DOSE2024-03-28NoNoCurrent
0002-2002-04000022002044 VIAL, SINGLE-DOSE in 1 CARTON (0002-2002-04) / .5 mL in 1 VIAL, SINGLE-DOSE2025-07-07NoNoCurrent